Category Archives: Genetics

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Halo Labs Inc. ("Halo" or the "Company") (NEO: HALO, OTCQX: AGEEF, Germany: A9KN) is pleased to announce that the Company has entered into an exclusive strategic partnership with Terphogz, LLC ("Zkittlez") to develop and commercialize new and unique cannabis genetics in Oregon.

Background & Partnership Highlights

Terphogz, LLC owns a genetic library that is well-known for creating the famous Zkittlez cannabis variety. Zkittlez has a unique and distinct terpene profile unlike other genetics in the market, making it distinguishable from other strains. Halo has secured a 5-year exclusive partnership with Zkittlez in Oregon to cultivate the groups strains and provide this beloved brand to the Oregon marketplace and consumers for the first time.

Halo will license and have exclusive rights to a large repertoire of genetic strains, most notably Zkittlez, Zmoothi and Z3 Kush. Focusing on the whole plant, Zkittlez has proven that THC alone cant compete with robust and unique terpene profiles. Highly awarded and recognized, the strains will allow Halo develop more brand and retail focused products aligning with the Companys long term growth strategy. With over 200,000 followers on social media and a history of excellence in cannabis genetics, Zkittlez provides extensive value to Halos already strong portfolio of cannabis consumer-centric partnerships.

"We are extremely excited to join forces with Halo. With our award-winning genetics and Halo's cultivation firepower, our collaboration will be a force to be reckoned with in Oregon. Stay tuned, we can't wait to get to work!" comments Green R. Fieldz, CEO of Terphogz, LLC.

Kiran Sidhu CEO and Co-Founder of Halo commented, "We are pleased to be partnering with Terphogz, LLC in Oregon to build a new branded product line of flower, pre-rolls and concentrates. Aligning with a beloved and Emerald Cup award winning brand such as Zkittlez to cultivate existing and develop new cannabis strains demonstrates Halos commitment to offering cannabis consumers access to some of the best genetics. We expect to do more projects with the Terphogz, LLC team and expand the partnership into additional markets."

About Halo

Halo is a leading cannabis cultivation, manufacturing, and distribution company that grows and extracts and processes quality cannabis flower, oils, and concentrates and has sold over 5 million grams of oils and concentrates since inception. Additionally, Halo has continued to evolve its business through delivering value with its products and now via verticalization in key markets in the United States and Africa with planned expansion into European and Canadian markets. With a consumer-centric focus, Halo markets innovative, branded, and private label products across multiple product categories.

Recently, the Company entered into binding agreements to acquire a dispensary in Los Angeles, 3 KushBar branded dispensaries, 5 development permits in Alberta Canada, and Canmart Limited which holds wholesale distribution and special licenses allowing the import and distribution of cannabis based products for medicinal use (CBPMs) in the United Kingdom. Halo is led by a strong, diverse management team with deep industry knowledge and blue-chip experience. The Company is currently operating in the United States in California, Oregon, and Nevada while having an international presence in Lesotho within a planned 200-hectare cultivation zone via Bophelo Bioscience & Wellness (Pty) Ltd. as well as planned importation and distribution in the United Kingdom via Canmart.

For further information regarding Halo, see Halos disclosure documents on SEDAR at http://www.sedar.com.

Cautionary Note Regarding Forward-Looking Information and Statements

This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only Halos beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of Halos control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or may contain statements that certain actions, events or results "may", "could", "would", "might" or "will be taken", "will continue", "will occur" or "will be achieved". The forward-looking information and forward-looking statements contained herein may include, but are not limited to, statements in respect of the Companys license arrangement with Terphogz, LLC and the cultivation, sale and distribution of Zkittlez branded and other products by the Company.

Story continues

By identifying such information and statements in this manner, Halo is alerting the reader that such information and statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from those expressed or implied by such information and statements. In addition, in connection with the forward-looking information and forward-looking statements contained in this press release, Halo has made certain assumptions. Although Halo believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. Among others, the key factors that could cause actual results to differ materially from those projected in the forward-looking information and statements are the following: unexpected costs or delays in the completion of the Company's proposed dispensaries and other operation; negative results experienced by the Company as a result of general economic conditions or the ongoing COVID-19 pandemic; delays in the ability of the Company to obtain certain regulatory approvals; unforeseen delays or costs in the completion of the Company's construction projects; adverse changes to demand for cannabis products; ongoing projects by competitors that may impact the relative size of the Companys growing operation; adverse changes in applicable laws; adverse changes in the application or enforcement of current laws, including those related to taxation; increasing costs of compliance with extensive government regulation; changes in general economic, business and political conditions, including changes in the financial markets; risks related to licensing, including the ability to obtain the requisite licenses or renew existing licenses for the Company's proposed operations; dependence upon third party service providers, skilled labor and other key inputs; and the other risks disclosed in the Company's annual information form dated April 16, 2020 and available on the Companys profile at http://www.sedar.com. Should one or more of these risks, uncertainties or other factors materialize, or should assumptions underlying the forward-looking information or statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected.

The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and Halo does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws. All subsequent written and oral forward-looking information and statements attributable to Halo or persons acting on its behalf is expressly qualified in its entirety by this notice.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200603005962/en/

Contacts

Halo LabsInvestor Relationsinfo@halocanna.com

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Halo Labs Announces Partnership with Zkittlez Providing Award Winning Genetics in Oregon - Yahoo Finance

When people respond negatively to an event, even one seemingly benign to others, they might talk of being triggered meaning an emotional button has been pushed, and a discomforting, upsetting or even traumatic experience has been conjured from the past.

Triggering is a big conversation.

The point here is that your reaction to the event is all to do with how the world has treated you.

Less discussed is the fact that some people are more sensitive than others.

Unhappy or stressful moments are felt more deeply: Its just the way they are.

Parents worry about this, sometimes hysterically. One of the kids cries or sooks more easily, more often.

Some wonder: Who did this to our child?

Others quietly lament that theyve spawned a weakling: Some quirk in the genetic marriage. Theyre half right.

A new study from Queen Mary University of London says: Some people are more sensitive to others and around half of these differences can be attributed to our genes.

The researchers, developmental psychologists, compared pairs of identical and non-identical 17-year-old twins to see how strongly they were affected by positive or negative experiences.

The idea was to establish each participants sensitivity level.

The plan was to tease out how much of the differences in sensitivity could be explained by either genetic or environmental factors during development.

As the researchers explain it:

This analysis concluded that 47 per cent of the differences in sensitivity between individuals were down to genetics, leaving 53 per cent accounted for by environmental factors.

The researchers says their study is the first to show this link conclusively in such a large study.

Michael Pluess, Professor of Developmental Psychology at Queen Mary University of London and study lead, said: We are all affected by what we experience sensitivity is something we all share as a basic human trait. But we also differ in how much of an impact our experiences have on us.

Scientists have always thought there was a genetic basis for sensitivity, but this is the first time weve been able to actually quantify how much of these differences in sensitivity are explained by genetic factors.

More than 2800 twins were involved in the study, split between about 1000 identical twins and 1800 non-identical twins, roughly half of whom were same sex.

The twins were asked to fill out a questionnaire, developed by Professor Pluess, which has been widely used to test an individuals levels of sensitivity to their environment.

This test will be made available online later this month so anyone can assess their sensitivity.

The questionnaire is designed to tease out different types of sensitivity whether someone is more sensitive to negative experiences or positive experiences as well as general sensitivity.

Co-researcher Dr Elham Assary said: If a child is more sensitive to negative experiences, it may be that they become more easily stressed and anxious in challenging situations.

On the other hand, if a child has a higher sensitivity to positive experiences, it may be that they are more responsive to good parenting or benefit more from psychological interventions at school.

What our study shows is that these different aspects of sensitivity all have a genetic basis.

The researchers also explored if there was a shared genetic component between sensitivity and the personality traits known as the Big Five.

These are openness, conscientiousness, agreeableness, extraversion and neuroticism.

They found that there was a shared genetic component between sensitivity, neuroticism and extraversion, but not with any of the other personality traits.

Professor Pluess said the findings could help us in how we understand and handle sensitivity, in ourselves and others.

He said: We know from previous research that around a third of people are at the higher end of the sensitivity spectrum. They are generally more strongly affected by their experiences.

This can have both advantages and disadvantages.

Because we now know that this sensitivity is as much due to biology as environment, it is important for people to accept their sensitivity as an important part of who they are and consider it as a strength, not just as a weakness.

Read the original:
Sensitivity is partly in our genes: New study with twins - The New Daily

A new market report by Verified Market Research on the Animal Genetics Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

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Leading Animal Genetics manufacturers/companies operating at both regional and global levels:

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According to the research report, one of the key challenges that might hinder the market growth is the presence of counter fit products. The market is witnessing the entry of a surging number of alternative products that use inferior ingredients.

Key factors influencing market growth:

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Animal Genetics Market 2019 Break Down by Top Companies, Countries, Applications, Challenges, Trends, Opportunities and Forecast 2026 - Cole of Duty

TORONTO--(BUSINESS WIRE)--Halo Labs Inc. ("Halo" or the "Company") (NEO: HALO, OTCQX: AGEEF, Germany: A9KN) is pleased to announce that the Company has entered into an exclusive strategic partnership with Terphogz, LLC (Zkittlez) to develop and commercialize new and unique cannabis genetics in Oregon.

Background & Partnership Highlights

Terphogz, LLC owns a genetic library that is well-known for creating the famous Zkittlez cannabis variety. Zkittlez has a unique and distinct terpene profile unlike other genetics in the market, making it distinguishable from other strains. Halo has secured a 5-year exclusive partnership with Zkittlez in Oregon to cultivate the groups strains and provide this beloved brand to the Oregon marketplace and consumers for the first time.

Halo will license and have exclusive rights to a large repertoire of genetic strains, most notably Zkittlez, Zmoothi and Z3 Kush. Focusing on the whole plant, Zkittlez has proven that THC alone cant compete with robust and unique terpene profiles. Highly awarded and recognized, the strains will allow Halo develop more brand and retail focused products aligning with the Companys long term growth strategy. With over 200,000 followers on social media and a history of excellence in cannabis genetics, Zkittlez provides extensive value to Halos already strong portfolio of cannabis consumer-centric partnerships.

We are extremely excited to join forces with Halo. With our award-winning genetics and Halo's cultivation firepower, our collaboration will be a force to be reckoned with in Oregon. Stay tuned, we can't wait to get to work!" comments Green R. Fieldz, CEO of Terphogz, LLC.

Kiran Sidhu CEO and Co-Founder of Halo commented, We are pleased to be partnering with Terphogz, LLC in Oregon to build a new branded product line of flower, pre-rolls and concentrates. Aligning with a beloved and Emerald Cup award winning brand such as Zkittlez to cultivate existing and develop new cannabis strains demonstrates Halos commitment to offering cannabis consumers access to some of the best genetics. We expect to do more projects with the Terphogz, LLC team and expand the partnership into additional markets.

About Halo

Halo is a leading cannabis cultivation, manufacturing, and distribution company that grows and extracts and processes quality cannabis flower, oils, and concentrates and has sold over 5 million grams of oils and concentrates since inception. Additionally, Halo has continued to evolve its business through delivering value with its products and now via verticalization in key markets in the United States and Africa with planned expansion into European and Canadian markets. With a consumer-centric focus, Halo markets innovative, branded, and private label products across multiple product categories.

Recently, the Company entered into binding agreements to acquire a dispensary in Los Angeles, 3 KushBar branded dispensaries, 5 development permits in Alberta Canada, and Canmart Limited which holds wholesale distribution and special licenses allowing the import and distribution of cannabis based products for medicinal use (CBPMs) in the United Kingdom. Halo is led by a strong, diverse management team with deep industry knowledge and blue-chip experience. The Company is currently operating in the United States in California, Oregon, and Nevada while having an international presence in Lesotho within a planned 200-hectare cultivation zone via Bophelo Bioscience & Wellness (Pty) Ltd. as well as planned importation and distribution in the United Kingdom via Canmart.

For further information regarding Halo, see Halos disclosure documents on SEDAR at http://www.sedar.com.

Cautionary Note Regarding Forward-Looking Information and Statements

This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only Halos beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of Halos control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or may contain statements that certain actions, events or results "may", "could", "would", "might" or "will be taken", "will continue", "will occur" or "will be achieved". The forward-looking information and forward-looking statements contained herein may include, but are not limited to, statements in respect of the Companys license arrangement with Terphogz, LLC and the cultivation, sale and distribution of Zkittlez branded and other products by the Company.

By identifying such information and statements in this manner, Halo is alerting the reader that such information and statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from those expressed or implied by such information and statements. In addition, in connection with the forward-looking information and forward-looking statements contained in this press release, Halo has made certain assumptions. Although Halo believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. Among others, the key factors that could cause actual results to differ materially from those projected in the forward-looking information and statements are the following: unexpected costs or delays in the completion of the Company's proposed dispensaries and other operation; negative results experienced by the Company as a result of general economic conditions or the ongoing COVID-19 pandemic; delays in the ability of the Company to obtain certain regulatory approvals; unforeseen delays or costs in the completion of the Company's construction projects; adverse changes to demand for cannabis products; ongoing projects by competitors that may impact the relative size of the Companys growing operation; adverse changes in applicable laws; adverse changes in the application or enforcement of current laws, including those related to taxation; increasing costs of compliance with extensive government regulation; changes in general economic, business and political conditions, including changes in the financial markets; risks related to licensing, including the ability to obtain the requisite licenses or renew existing licenses for the Company's proposed operations; dependence upon third party service providers, skilled labor and other key inputs; and the other risks disclosed in the Company's annual information form dated April 16, 2020 and available on the Companys profile at http://www.sedar.com. Should one or more of these risks, uncertainties or other factors materialize, or should assumptions underlying the forward-looking information or statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected.

The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and Halo does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws. All subsequent written and oral forward-looking information and statements attributable to Halo or persons acting on its behalf is expressly qualified in its entirety by this notice.

Read more:
Halo Labs Announces Partnership with Zkittlez Providing Award Winning Genetics in Oregon - Business Wire

SALT LAKE CITY, June 04, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN, Myriad or the Company), a global leader in molecular diagnostics and precision medicine, today announced the publication of a prospective study demonstrating that the EndoPredict test predicts which patients with ER+, HER2- early-stage breast cancer will benefit from neoadjuvant therapy. The article titled, The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial, appeared online in theEuropean Journal of Cancer.

This study demonstrated that the EndoPredict (EP) test predicted response to neoadjuvant chemotherapy or neoadjuvant endocrine therapy in women with ER+, HER2 negative early-stage breast cancer, said Peter Dubsky, M.D., lead author, speaking on behalf of the Austrian Breast and Colorectal Cancer Study Group (ABCSG). Based on these findings and prior studies, we are confident the EndoPredict test can add valuable information to aid in personalized treatment selection in neoadjuvant therapy and provides an important basis for future design of neoadjuvant clinical trials.

The primary objective of this prospective study was to test the predictive value of the EndoPredict test regarding tumor response after neoadjuvant chemotherapy (NaCT) or neoadjuvant endocrine therapy (NET) within the ABCSG-34 trial. The analysis included data from 217 women with HR+ breast cancer. Of these, 134 patients were assigned to receive NaCT (eight cycles of anthracycline/taxane) according to aggressive clinico-pathologic tumor features. The remaining 83 patients were clinically identified as having luminal A-like types of breast cancer and were assigned to receive NET (six months of letrozole). The primary endpoint was residual cancer burden RCB0/I (i.e., good tumor response) vs. RCB II/III (i.e., poor tumor response) at time of surgery.

In the neoadjuvant chemotherapy group, 125 patients had high EP scores and nine had a low EP score. The results show that 26.4 percent of those with a high score showed a good tumor response (RCB0/I) to neoadjuvant chemotherapy, while all patients with a low score showed only a poor tumor response (Table 1). In the luminal A group receiving neoendocrine therapy, 39 patients had a high EP score and 44 had a low EP score. The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy (Table 1).

EndoPredict Low Score

EndoPredict High Score

0.0

%

26.4

%

p=0.0001

In this prospective study, we demonstrated that the EndoPredict test is a useful tool pre-operatively, said Ralf Kronenwett, M.D., director of International Medical Affairs at Myriad. In two distinct ER-positive, HER2-negative cohorts selected by clinicians to receive neoadjuvant chemotherapy or neoadjuvant endocrine therapy, EndoPredict identified patients with poor neoadjuvant treatment response. Clinicians can use information to determine who might forgo these therapies prior to surgery.

About EndoPredictEndoPredict is a second-generation, 12-gene molecular prognostic test for patients diagnosed with breast cancer. The test provides vital information that helps clinicians devise personalized treatment plans for their patients. EndoPredict has been validated in more than 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: http://www.endopredict.com.

About Myriad GeneticsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the EndoPredict test adding valuable information to aid in personalized treatment selection in neoadjuvant therapy and providing an important basis for future design of neoadjuvant clinical trials; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Excerpt from:
Myriad Genetics Announces Publication of a Prospective Clinical Study of the EndoPredict Test in Women with Early-Stage Breast Cancer - GlobeNewswire

Historically, Western Asia, which includes todays Middle East, is one of civilizations most important geographical locations. Not only did it create some of humanitys earliest cities, but its early trade routes laid the foundation for what would become the Silk Road, a route that commercially linked Asia, Africa, and Europe.

Even before they connected with other regions, however, populations across Western Asia had already developed their own distinct traditions and systems of social organization. The areas studied in this paper played major roles in the evolution from farming to pastoral communities to early state-level societies.

With the study, the researchers wanted to fill in some of the anthropological gaps between the origins of agriculture and of cities to get a better grip on how these different communities came together, a dynamic that is still not understood well.

What we see in archaeology is that the interconnectivity within Western Asia increased and areas such as Anatolia, the Northern Levant, and the Caucasus became a hub for [the] exchange of ideas and material culture, said Eirini Skourtanioti, a Ph.D. student at the Max Planck Institute and the lead author of the study, in avideoaccompanying the release of the paper. The goal of our study was to understand the role of human mobility throughout this process.

The authors came from many disciplines and countries, including Australia, Azerbaijan, France, Italy, Germany, South Korea, Turkey, and the U.S. They gathered 110 ancient remains from museums and labs around the world, and took samples from teeth and part of the temporal bone called the petrous, which houses the inner ear. The genetic analysis was conducted by scientists at the Max Planck Institute, including Warinner.

The paper outlines how populations across Anatolia and the Southern Caucasus began mixing approximately 8,500 years ago. That resulted in a gradual change in genetic profile that over a millennium slowly spread across both areas and entered into what is now Northern Iraq. Known as a cline in genetics, this mixture indicated to the researchers ongoing human mobility in the area and the development of a regional genetic melting pot in and surrounding Anatolia.

We see the past through artifacts, through the evidence people leave behind. But sometimes events are happening that dont leave traces in conventional ways.

Christina Warinner

The other shift researchers detected wasnt as gradual. They looked at samples from the ancient cities of Alalakh and Ebla in what is today Southern Turkey and Northern Syria, and saw that around 4,000 years ago the Northern Levant experienced a relatively sudden introduction of new people.

The genetic shifts point to a mass migration. The timing corresponds with a severe drought in Northern Mesopotamia, which likely resulted in an exodus to the Northern Levant. The scientists cant be sure, because they have no well-preserved genomes for people who lived in Mesopotamia.

Along with findings on interconnectivity in the region, the paper presents new information about long-distance migration during the late Bronze Age, roughly 4,000 years ago. A lone corpse, found buried in a well, was genetically linked to people who then lived in Central Asia, not in part of present-day Turkey.

We cant exactly know her story, but we can piece together a lot of information that suggests that either she or her ancestors were fairly recent migrants from Central Asia, said Warinner, who is also a group leader in the Department of Archaeogenetics at the Max Planck Institute. We dont know the context in which they arrived in the Eastern Mediterranean, but this is a period of increasing connectivity in this part of the world.

The corpse had many injuries and the way she was buried indicated a violent death. Warinner hopes more genomic analysis can help unravel the ancient womans story.

For Warinner, who earned her masters in 2008 and her Ph.D. in 2010 from theGraduate School of Arts and Sciences, such studies are proof of the insights DNA analysis can provide when traditional clues dont tell the full story.

Whats really interesting is that we see these populations are mixing genetically long before we see clear material culture evidence of this so long before we see direct evidence in pottery or tools or any of these more conventional archaeological evidence artifacts, Warinner said. Thats important because sometimes were limited in how we see the past. We see the past through artifacts, through the evidence people leave behind. But sometimes events are happening that dont leave traces in conventional ways, so by using genetics, we were able to access this much earlier mixing of populations that wasnt apparent before.

(Reprinted with permission from the Harvard Gazette.)

Originally posted here:
Earliest Genetic Glimpses of the Movement and Mingling of Peoples in West Asia 8,500 Years Ago - India New England

Those who follow the science behind autism may know that there is an explosion of scientific research happening in the field right now.In January Mount Sinai Hospital published a study that identified 102 genes associated with autism. A paper published in Biological Psychiatry earlier this month suggests that a gene mutation may be linked to autistic behaviors. And arecent government studyfound that children who have an autistic uncle or aunt have a more than doubled risk of being diagnosed with the condition themselves.

At the crux of these studies and so many others are questions about why some people have this very unique type of brain. If you're on the autism spectrum, you're likely to be more intelligent than average, but also to struggle more in social situations. You have skills that can make you excel in many career paths, but are also more likely to face very unique types of employment-based discrimination along the way.

What causes people to develop like this? Is it in our genes, due to environmental factors or caused by some combination of both factors? This question, known colloquially as the "nature versus nurture" debate in biology, is innate to much psychology and sociobiology research. To wit: intelligence, disorders like ADHD, and personality disorders all have aspects that are develpmental or environmental and aspects that are genetic.

To learn more about new research in thenature versus nurture debate for autism, I turned to Temple Grandin for answers and this is the part where I need to add that I'm not neutral about Temple Grandin.

The advocate of humane treatment for livestock, who was the focus of the 2010 movie "Temple Grandin" starring Claire Danes, is a hero of the autism community, for which she has emerged as a major spokesperson. I am also on the autism spectrum and, as such, she is a person to whom I have reached out more than once about questions about issues facing my community. She is unquestionably brilliant, blunt to a fault, passionate about helping people and animals and yet clearly one who does not suffer fools gladly.

She also, as I quickly learned, has a talent for explaining autism in a way that makes it easy for virtually anyone to understand. I suspect the readers of this interview will agree. As always, this interview has been condensed and edited for print.

Let's talk about the genetics of autism. We were talking about a January study done at Mt. Sinai Hospital which found that there are 102 genes associated with autism. Do you tend to agree with it?

Well I have no reason not to agree with the study. Basically, autism is a continuous trait. There's a lot of traits where many many genes contribute just a little bit....Some of the genes were associated with other types of developmental delays. There's also a lot of research that shows that there's a crossover between ADHD and autism. Even in the brain scans, there is crossover. I've got some of those references in the new edition of "The Way I See It." Basically, you have a whole lot of little tiny code variations that contribute a little bit and they all have to do with brain development.

Now, I've told you about my own genome scanning. My genes have been totally scanned. What I found is other health problems I have anxiety, bad skin, bad teeth that showed right up. Simple genetics. But the autism stuff, yeah, I got some of the at-risk genes. It gets back into basic brain development.

I told you about the paper called"Genomic Trade-Offs: Are Autism and Schizophrenia the Steep Price of the Human Brain?" This is a quote from their abstract this isn't the way I would have put it but they said, "The genes that make us mad, make us human." That's a quote out of the abstract of the paper. It's not me saying that. I say that the same genes that make the brain big are also involved with autism and schizophrenia. It's a whole lot of little genes. It's a whole lot of little, I call them code variations. There's actually some argument in the literature to exactly what a gene is. I mean there's simple genetic stuff like brown or black coats on Angus cattle. That's very very simple genetics. That's Mendelian genetics. You need to forget about that.

I also went back and looked up some of the twin studies. Some of these were done ages ago. I found a nice review article on "Heritability of Autism Spectrum Disorders: A Meta-analysis of Twin Studies." It's a nice review article on twin studies. Some of this research is very old.

It sounds like you're saying that you believe nature plays a larger role than nurture in creating autism?

Yes. When it comes to nature, what's been found in twin studies, that when child is brought up anywhere resembling a decent environment, there's a lot of traits where genetics has a big effect on it. You get into a lot of things across the board. I'm going to say a person, what they become, is half-nature and half-nurture. It's the same thing with an animal. Some traits are much more genetic than others. One trait that's really genetic is the tendency to startle. This is true with cattle and horses, like if you open an umbrella suddenly, some horses are going to rear up and hit the roof and others will just flinch. Now what context are you discussing nature and nurture?

I'm talking about the question of when people are born on the autism spectrum, to what degree is that because of their genes and to what degree is that because of environmental factors that influence their neurological development, like the way their raised, the degree to which they're exposed to various potentially intellectually stimulating stimuli, things like that.

Well those things all have an effect. Let's say you took a young autistic kid like me and you did no early intervention. I don't think I would have become a college professor. So in terms of what you might become, maybe I'd be in an institution somewhere if nothing had been done with me.

I wonder the same thing about myself.

Well this is the problem, you see? This is something I tell parents all the time: I talk to a lot of low income families and say, You got a kid, he's two-and-a-half or three years old, he's not talking, he sits in the corner rocking, you've got a problem. I don't care whether you've got an official diagnosis or not, work with this kid now. I suggest that they go to their church group and get some volunteers, and you need to start taking turns playing games with the kid. Just start teaching him words, get down to work with this kids. If he just sits there and vegetates, he ain't going anywhere. So okay, that's an environmental influence there.

But then there's other kids that don't work as hard. Some of them can learn to type independently. I mean both nature and nurture are important in determining what a person could accomplish.

I'm going to just take it animals and people both, I'm going to say half-and-half, in terms of what you become. I talk to educators about the goal of education and say, let's look at where a student is 10 years after high school. Well, 10 years after high school I was doing that big dip vat project that was shown in the movie. That was 10 years after high school almost exactly. Okay if the kid's ending up in jail or some other bad thing, certainly don't want him there.

From a cultural perspective, what do you think the implications of this are? Obviously the science is pretty cut and dried. In terms of how society views people who are intelligent [but] also display non-neurotypical traits, do you think this paper could possibly change the way we perceive those who are on the spectrum?

First of all, I never told anyone I had autism. You know what my biggest barrier was in the '70s in the feedlot industry, the cattle industry, in Arizona in the '70s? Being a woman. Much bigger barrier than autism ever was. Being a woman was the biggest barrier. I got kicked out of places for being a woman.

So you're saying that's a much bigger barrier for you than being on the spectrum?

For much of my career, a much bigger barrier. Early 1970s, I want to emphasize early '70s, much bigger barrier, much bigger barrier. This is the early '70s when I started.

And the way, what I did is I had to prove to them. I had to be three times better than a guy. The thing that I got people to accept me is when I showed my work. I would lay the drawings out. I'd go in for an interview and I'd take a big drawing, lay it out on the table, put all the pictures out there that I had, pictures of jobs. I'd give them my brochure, I'd give trade magazine articles that I'd written. I just would show off the work, period. I showed the work. That was my total way of doing it and I wrote about my projects.

But if we're talking about people who do struggle because they're not neurotypical, and they tend to be intelligent but society views them

I can't talk in abstractions. I'm a visual thinker, I only think in specific examples. Then I take specific examples and I put them into categories. Very verbalized, abstract things, I can only get specific examples of all right, here's a person where they had a successful career, here's a person that did not. What could have derailed their career?

I could talk about myself. This isn't so much in terms of derailing my career, but when I tell people I'm on the autism spectrum and that I struggle with mental health issues like ADD, anxiety, depression frequently they respond by saying "Well you're so very intelligent." It seems like there is a struggle in reconciling the fact that I'm bright with the fact that I have all of these mental health issues. I know other people who are also successful in their careers who have had similar reactions.

So my question is, it seems like there's a cultural tendency to assume that if you struggle with mental health issues or you're not neurotypical, that means you're not very bright. And if you are very bright, that means you're well adjusted.

Intelligence and creativity is associated with mental health issues. I'm right now reviewing some literature on visual thinking and I'm finding papers where right now I'm looking at a bunch of journal articles I looked up online about the ability to remember your past. People who get really bad PTSD, the past just comes back like pictures. Then you've got people that are highly verbal, it's easier for them to forget that bad things have happened to them in the past. Some of those visual thinkers, they're really creative. I've worked with them on equipment design. I worked with two guys that had 20 patents each. Yeah they had problems drinking, they had some problems. They ended up both on Prozac and that basically saved them from the gutter. One still has a very successful business. I have to be very vague about what they do, I cannot identify them, they're still alive, [one] still owns a very successful business. I know he has problems with drinking. It's mechanical, very clever mechanical engineering is what he did, what he does.

That's where I was going with my earlier question. There seem to be these cultural assumptions that are not borne out by the scientific data. There is something else I want to go into, which is you're talking about the different types. In your book, you discuss the different types of autistic brains, the different manifestations

Of thinkers, different thinkers. I'm right now reviewing literature on this, recent literature. It's very clear that you've got some people, now they're not looking at mental health here, they're just looking at more career stuff. Object visualizer, that would be me. Thinks in pictures, often ends up in the arts, industrial designs. Then you have the visual-spatial, or mathematical mind, thinks in patterns. Then you have people that totally think in words. I'm right now reviewing literature right now, new literature, stuff published since 2016 after I did"The Autistic Brain", that totally supports this idea that you've got some people ... They have people that are mixtures though, the intermediate.

The person who is a super good object visualizer is going to be crappy in math, not good at math and the more spatial way of looking at things, the more mathematical way of looking at things. There's getting to be good evidence. The object visualizer and visual-spatial, the skills sort of are antagonistic. You can't be super good at both. You can be intermediate at both. But the people that are super good at object visualizing, like they are horrible at the more abstract, schematic and mathematic way of visual spatial. I'm horrible on a thing called paper fold test. I flunked that. Just last night, I took a little mechanical aptitude test that was online. I had to speed through and I got seven out of 10 right. I'm pretty sure I know which ones I got wrong.

For me personally, I've always been very good at writing and I tend to absorb a lot of information. I can read a 500-page book in a few hours and remember all of the major facts within that book months and months later. So I guess what category of intelligence would I then be in?

Let me just ask you a question. I want you to think about cell phone towers. How do they come into your mind?

I imagine a large metal tower in the middle of the woods.

Is it a specific or general?

I just imagine the concept of the tower. I don't visualize it.

Yeah, the visual thinker starts naming them off. Now I'm thinking of it, there's one I go by that's next to a gas station. It's one of their best fake trees but it's still really fake looking. As I talk about it now I see it.

Yeah, I just imagine the concept of a tower.

I take specific examples of cell phone towers. Now there's another cell phone tower, it's actually the Hilton hotel and they now have them along the edge of the roof. I see. I've also seen them used as church steeples. I'll never forget when I asked, this is when I discovered that some people didn't think visually, I asked a speech therapist at an autism conference, think about a church steeple. She just got very vague pointy thing. I see it and I start naming them off. Visual thinkers just come up, just like it showed in the movie, like PowerPoint slides.

So for me, I just think of the concept, I don't think of specifics.

Well then you're more verbal. You're probably a lot more verbal.

How would you say cultural attitudes towards non-neurotypical personality types have changed over the last 40 to 50 year?

Well it has changed. I look back on the people I worked with, welders and designer. The people who have the 20 patents, neither one of those, one barely graduated from high school and the other one I think dropped out of high school. They couldn't do math but they've got 20 patents and their stuff is out being used in the industry. They were saved by welding class. One guy he just started making stuff and selling it at local trade shows. That grew into a big business. I worked with welders, I worked with a lot of people. If I tell you of people I worked with on my projects, I'm going to guess 20 percent of them would be considered neurodiverse today. But this is long before that term ever [became popularized]. 20 percent were either autistic, dyslexic, or ADHD. There was one guy, looking at him now, he was sound sensitive. I'll never forget the job where I was chipping the slag off of his welds and me tapping with the chipping hammer drove him just crazy. I didn't realize it. This was back in 1980.

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Interview with Temple Grandin: Autism, genetics and the steep price of being intelligent - Salon

Ancestry and 23andMe offer direct-to-consumer DNA tests.(Photo: Reviewed.com/Jackson Ruckar)

It's a question that has vexed researchers from the beginning of the coronavirus outbreak: Why do some people get severely ill and die from COVID-19, while others have mild symptoms or none at all?

Now, scientists at two direct-to-consumer genealogy DNA companies hope to use the genomesthey've collected from millions of people over the years to see if they can find a genetic explanation toanswer that question.

Both 23andMe and Ancestry have launched COVID-19 studies, asking U.S. adult customers who've already submitted DNA samples to answer online questions about how the virus affected or didn't affect them.

"From the early days ... I think it was clear to all of us that some people were getting very, very sick when they were affected with coronavirus, and some people had hardly any symptoms at all," said Dr. Catherine Ball,chief scientific officer at Utah-based Ancestry."It turns out that there are plenty of people who have no symptoms. The spectrum of human response to the same pathogen is unusual.

"And even with a bunch of comorbidities and other problems, it's still remarkably divergent in different people, even if they have the same age and have the same overall health. And soto geneticists, that looks like there's a genetic factor in whether people become infected in the first placeor have serious or mild symptoms."

With 16 million people who've already spit in vials and sent them to Ancestryfor genetic testing to find blood relatives who might be closely or distantly related or learn how much of their DNA suggests their relatives came from Africa or Asia or were Native American or European, Ball said the companyknew it had a potentially useful data pool to tap for COVID-19 research.

"We clearly want to take the opportunity to unleash that power to be able to see if there are genetic signals, and be able to help researchers and people making drugs and therapeutics and vaccines dosmarter work faster," she said.

Dr. Catherine Ball, chief scientific officer for Utah-based Ancestry.(Photo: Ancestry)

Of those 16 million DNA customers through Ancestry, so far about 500,000people have already taken an online survey to participate in the company'scoronavirus research.

At 23andMe, principal scientist Adam Auton said the California-based company's COVID-19 genome-wide association study launched in April.

About 10 million of itsgenotype customers are eligible for the study, he said.Of them, about 80%have consented to participate in research, and600,000 customers have opted into the COVID-19 study.

"It is a really quite tremendous response to the study and I think shows that people really do want to try and contribute to help understand and fight this disease," said Auton.

Both Ancestry and 23andMeacknowledge that the bigger the sample size, the better their research will be.

"Never ask a scientisthow much data she needsbecause she always needs more," Ball said. "We're really hoping to get a minimum of a million respondentsbecause we need to have a decent number of people who have tested positive to give us a statistical signal."

So far, about9,000 people in 23andMe'sCOVID-19 study reported that theytested positive for coronavirus.

"That's a pretty substantial number," Auton said. "However, it's the nature of genetic studies that we really need very large numbers of people to be able to draw connections between the genetic information and people's health information."

A worker at 23andMe performs DNA testing on samples provided by customers.(Photo: 23andMe)

Since the pandemic began,about 1.6million people in the United States, a country of 330 million, have tested positive for COVID-19. As the virus continues to spread,and more people get coronavirus diagnoses, the companies suspect that the number of people who will go on to enroll in their studies also is likely to rise.

"We understand this is an evolving situation," Ball said. "And while we can't shelter in place forever, at some point, as we're opening up our cities and states, more people will start contracting the virus."

Anyone who may have already filled out anonline COVID-19 survey on Ancestry.com or 23andMe.com, saying they had not yet had the virus, can go back and revise their answers later to reflect that they've contracted it.

To expand its research of people who've had COVID-19 even more, Auton said 23andMeis now offering tomail a free DNA test kit to any U.S adult who was hospitalized with COVID-19, but has not yet submitted a DNA sample to the company.

"We are essentially asking if people have been hospitalized with COVID-19, and they have recovered, if they would like to participate inour research. They can come to our website and we'll offer them a free kit,"Auton said.

The contents of a 23andMe kit.(Photo: 23andMe)

"We're very much interested in trying to get the word out so that people to hear about this because really every data point is going to be pretty valuable."

23andMe has emailed customers in areas hardest hit so far in the pandemic including those in Michiganto let them know about its study, Auton said.

"The best thing that we can do to make a difference for COVID is to really publish the results that we find and make them available to the research and scientific communities," he said.

23andMe haspublishedmore than 150 studies in peer-reviewed scientific journals, "the majority of which come from collaboration with the broader academic and the scientific community," Auton said,since it launched in 2006with its direct-to-consumer DNA kit.

But the company ran afoul of the U.S. Food and Drug Administration in 2013, when the agency ordered 23andMeto halt the release of genetic health information to customers, saying the company had yet to prove its tests were"analytically or clinically validated."

After revamping, the company passed FDA muster in 2017, and got authorization tooffergenetic healthreports that outlinedrisk for 10conditions, including late-onset Alzheimers disease andParkinsons disease.

Ancestry is new to the health genetics business. It launched AncestryHealth in 2019, with the disclaimer that its tests are physician-ordered and not diagnostic, but offer "health insights" into whether a person might be a carrier for cystic fibrosis or sickle cell anemia or whether there's a genetic variant associated with a higher risk for breast cancer or colon cancer.

Ball said Ancestry also will seek to publish its COVID-19 research findings, too.

"We will be doing our very best to publish our findings as quickly as possible, and making them as useful to clinicians and other researchers as quickly as possible," she said.

Ancestry DNA(Photo: Melissa Rorech)

Both companies are looking for research partners for the coronavirus studies. Ancestry has had nibbles from universities, biotech and pharmaceutical companies, but Ball said, right now, the focus is on safeguarding the privacy of its customers.

"We typically do not share data out with third parties," Ball said. "That's an unusual activity for us.

"We will not be sharingpersonal data. Everything will be de-identified. So names, email addresses, your address, your ZIP code, your phone number, all that stuff will be stripped and will not be shared. We do want to still be very conservative because it is people's genetic data."

At 23andMe, individual-level data is never shared with a third party "without explicit additional consent from participants," Auton said.

"The information that we're talking about here, where we would be working with the academic community, is all aggregated at a very high level. So it's really just information about whether a specific genetic variant is associated with the disease. It doesn't contain any information about the individuals in the study."

Ball urged people to consider participating in this research for the common good.

"The people who came to AncestryDNA were interested in finding out about their ancestors, their past and their history," she said."This is our chancein this moment of history ... to take 5-10 minutes ... and do our best to help our community of friends or familyand the people who we don't even know who will be coming along later.

"It's our chance to contribute to the benefit of everybody. And I think right now, it'san opportunity that resonates with a lot of people."

Auton said the research could lead to therapies or treatments for people sickened by COVID-19.

"Hopefully, that can make a difference," he said.

Contact Kristen Jordan Shamus: 313-222-5997 or kshamus@freepress.com. Follow her on Twitter @kristenshamus.

Read or Share this story: https://www.freep.com/story/news/health/2020/05/26/genes-dna-ancestry-23-andme-coronavirus-covid-19/5223568002/

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Genetic genealogy companies Ancestry, 23andMe begin COVID-19 research - Detroit Free Press

Researchers are learning more about genetic aberrations common in the rare but clinically aggressive hematological cancer blastic plasmacytoid dendritic cell neoplasm. There is one targeted therapy approved by the U.S. Food and Drug Administration: Elzonris (tagraxofusp-erzs, Stemline). However, more treatment options are needed to improve the cancers clinical outcome, according to a review published May 2020 in Critical Reviews Oncology/Hematology.1

Dermatologists might be the first providers to encounter patients with blastic plasmacytoid dendritic cell neoplasm because more than 70% of these patients have cutaneous lesions. Those lesions often are asymptomatic and vary in size. The skin lesions tend to have nodules, plaques or bruise-like areas, a brown to violet color and might be solitary or multifocal, according to the authors.

Blastic plasmacytoid dendritic cell neoplasm often originates from type 2 myeloid-derived resting plasmacytoid dendritic cell precursors. Recent research suggests providers can diagnose the cancer when patients express at least four of five plasmacytoid dendritic cell specific markers, CD4, CD56, CD123, TCL1 and BDCA-2, without expressing myeloid, T-cell or B-cell lineage markers.

Commonly, [blastic plasmacytoid dendritic cell neoplasm] is characterized by high CD123 expression, aberrant NF-B [nuclear factor-B] activation, dependence on TCF4-/BRD4-network, and deregulated cholesterol metabolism, they wrote.

Despite advancing knowledge about the cancer type, patients median overall survival remains at 12 to 14 months, according to the paper. Conventional treatment approaches include chemotherapy, radiotherapy and ultimately hematopoietic stem cell transplantation. The challenges with conventional therapies are while blastic plasmacytoid dendritic cell neoplasm is sensitive to some chemotherapy regimens, patient relapse is high at more than 60%. And many patients with blastic plasmacytoid dendritic cell neoplasm are too old or frail to have intensive chemotherapy or hematopoietic stem cell transplantation, according to the authors.

Recently, the most attractive agent for [blastic plasmacytoid dendritic cell neoplasm] is tagraxofusp, which is composed of the catalytic and translocation domains of diphtheria toxin (DT) fused to interleukin-3 (IL-3), the authors wrote.

Blastic plasmacytoid dendritic cell neoplasm cells overexpress interleukin-3 receptor subunit alpha (IL3RA, also called CD123). Elzonris, or tagraxofusp-erzs, is a CD123-directed cytotoxin given intravenously, which is used to treat blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric patients 2 years and older.

Researchers reported in a study of 47 blastic plasmacytoid dendritic cell neoplasm patients published in 2019 in the New England Journal of Medicine that tagraxofusp led to clinical responses in untreated and relapsed patients.2 The overall response rate with tagraxofusp was 90% and the primary outcome of complete response and clinical complete response was 72% among the previously untreated patients. Overall response was 67% in the previously treated patients. Serious adverse events including capillary leak syndrome, hepatic dysfunction and thrombocytopenia were common, according to the NEJM paper.

More targeted therapies are needed to treat blastic plasmacytoid dendritic cell neoplasm, but many potential therapeutic agents are not advancing to clinical trials, according to authors of the paper in Critical Reviews Oncology/Hematology.

Common blastic plasmacytoid dendritic cell neoplasm characteristics are genetically heterogeneous and provide valuable drug targets, according to the authors.

Apart from aberrant activation of NF-B signaling pathway, which is highly dependent on TCF4- and BRD4- transcriptional networks, cholesterol metabolism deregulation and CD123 expression, defects of DNA damage repair and mitosis are new, potential common features of the cancer. Corresponding therapies might be promising, the authors wrote.

Venetoclax, anti-CD123 CAR-T, XmAb14045 and IMGN632 are in clinical trials for blastic plasmacytoid dendritic cell neoplasm. But the authors noted that bortezomib, lenalidomide, 5-aza and pralatrexate could easily be pushed to the front line of the cancers treatment.

Disclosures:

The authors report no relevant disclosures.

References:

1. Zhang X, Sun J, Yang M, Wang L, Jin J. New perspectives in genetics and targeted therapy for blastic plasmacytoid dendritic cell neoplasm. Crit Rev Oncol Hematol. 2020 May;149:102928.2. Pemmaraju N, Lane AA, Sweet KL, et al. Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm. N Engl J Med. 2019;380(17):1628-1637.

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Genetic features pave way for targeted BPDCN therapies - Dermatology Times

A month following surgery for thyroid cancer, a Hartford Hospital patients tumor grew to 10 inches. The case was presented to the hospitals tumor board, which involved 30 doctors from different specialties.

The gene mutation found to be controlling the patients tumor growth was already well-established as a driver of melanoma, the deadliest form of skin cancer, says Dr. Sope Olugbile, medical oncologist at Hartford HealthCare.Chemotherapy wouldnt work fast enough against the aggressive tumor. Tumor board members recommended a targeted therapy already treating patients with melanoma. Without that genetic information, we wouldnt have been able to come up with that therapy, he says. The treatment saved the patients life, so far. Our goal is to use more of the genetic information to drive the treatment of cancer patients.

This type of personalized care, known as precision medicine and its subset, genomic medicine, has been offered for years at world-renowned cancer-treatment hospitals such as Memorial Sloan Kettering Cancer Center in New York, Dana-Farber Cancer Institute in Boston and University of Texas MD Anderson Cancer Center in Houston. Its now the standard of care in Connecticuts Hartford HealthCare Cancer Institute, UConn Health Center in Farmington, Connecticut Childrens Medical Center in Hartford and Smilow Cancer Center at Yale New Haven Health.Cancer therapy has become precision therapy, says Dr. Roy Herbst, professor of medicinal oncology and pharmacology, and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital.

Dr. Roy Herbst, of Yale Cancer Center and Smilow Cancer Hospital, says that precision care is often used in cancer treatment these days.

While its most commonly used with cancer patients, precision medicine is also making inroads into other areas of health care including the treatment of some cardiac patients. Its also being studied and used on a limited basis to treat those with rare diseases. In the U.S., newborns are screened with a blood test for hearing loss and heart defects. If detected and treated early, this can prevent death and disability in some cases. For some doctors and researchers, precision medicine holds the promise of effective targeted diseases and chronic conditions, and, even more revolutionary, the chance to prevent illness before it arises. The race is on to gather as much data as possible in order to increase understanding of the connection between genes and overall health; here in Connecticut, Yales Center for Genetic Health last fall launched its Generations project to collect DNA from 100,000 volunteers (see sidebar below).

Precision medicine involves the study of human genes, called the genome. The human genome contains 23 pairs of chromosomes within all human cells, and each chromosome contains hundreds to thousands of genes. Using high-level computing and mathematics, genomics researchers analyze massive amounts of DNA-sequence data to find variations or mutations that affect health, disease or response to drugs, according to an online description by The Jackson Laboratory for Genomic Medicine in Farmington.

Researchers can sequence an entire tumor to look for markers or abnormalities that can be treated with a targeted medication that attacks that mutation, unlike traditional chemotherapy that kills healthy cells along with cancer cells, says Herbst, also associate director for translational science at the Yale School of Medicine.

These days, when Yales precision medicine tumor board meets weekly, they dont focus on where the tumor began, he says. They look at what errors occurred in the DNA of the tumor, because once they know whats driving the tumor, they can treat it.For example, lung cancer is the most common cancer in the world. When a nonsmoker gets lung cancer, doctors sequence the tumors DNA to see if it contains one of eight genes known to mutate.

Each cancer cell has about 18,000 to 20,000 genes, and there are some cancers where just one of those genes is directing the growth of the cancer, Olugbile says. We call that the driver gene. The other 17,999 are just following the lead of that driver gene, he says. That means if we tag just that one gene with the medication then we can actually shut down the growth of the entire cancer.

Traditional chemotherapy can only be given for 4-6 months because of the side effects, while targeted oral medications have very few side effects and patients remain on them for an average of two years, Olugbile says.

In the past five years, genetic testing has become standard of care for some cancers specifically colon, lung and melanoma because those types of cancers tend to have genetic mutations that have been known to respond to therapy, says Sara Patterson, manager of clinical analytics and curation at Jackson Labs, which works with UConn and Yale researchers.But targeted therapy is not a cure-all, and researchers are still a long way from using precision medicine to treat all cancer patients. Even if cancers have the same genomic change and mutation, theres no guarantee they will all respond to the same therapy, she says.Overall, precision medicine is only effective at stopping the spread of cancer in an average of 20 percent of cancer patients treated, Olugbile says, with variations by cancer. Sometimes the cancer returns because the tumor changes to resist the therapy, Patterson adds.

As doctors and researchers do more genomic sequencing, the data pool will grow and so will knowledge of what medications work most effectively against various tumor types.The more information we gather, the better well know how to treat specific patients, Patterson says.

Reimbursement from insurance companies can be a challenge. If precision treatment for a particular type of cancer hasnt been approved by the insurance industry, its difficult to get reimbursed for genomic testing, says Sue Mockus, director of product innovation and strategic commercialization at Jackson Labs.Its a catch-22. Even though a patient with pancreatic cancer could benefit from a targeted therapy, unless that patient is part of a clinical trial that would pay for the genomic testing, the patient would have to pay out of pocket, the annual cost of which can run into the hundreds of thousands of dollars. If you do have a mutation identified and your physician wants to give you the medication off label, you have to fight with the insurance company, Mockus says.

Experts have suggested a value-based approach to precision medicine, reports the International Journal of Public Health. This means policy decisions about reimbursement and investment in research and development will factor in how long patients lives are prolonged and the quality of those lives, the Journal reports.

Oncologists also offer cancer patients immunotherapy, another form of personalized medicine, Patterson says. Theyre using diagnostic tests on tumors, independent of genomic sequencing, to determine if their tumor profiles make them a good immunotherapy candidate. Immunotherapy is approved for multiple tumor types, as long as they have certain markers, she says.

Former President Jimmy Carter became cancer free after receiving radiation and immunotherapy to treat the melanoma that had spread to his brain and liver. While immunotherapy can cure cancer for some, its only effective about 20 percent of the time, Olugbile says. It varies a bit by cancer, with some cancers having a higher success rate, he adds.

Through a collaboration with Memorial Sloan Kettering, Hartford HealthCares Advanced Disease Clinic was scheduled to open this spring to give patients even more options, he says. If targeted therapies and immunotherapies dont work or are not a match for patients, doctors will look for suitable clinical trials that offer potential treatments, Olugbile says.Our goal is to create awareness on two fronts, one is among the doctors. Yes, we are available to help if patients have gone through standard of care who didnt respond, he says. Its also an option for patients who want to be treated with precision medicine closer to home. The goal is to make it available so they dont have to go to New York or Boston, he says. Its right here in Hartford and hopefully at other cancer centers over time.

From Yale, Herbst leads a clinical trial through the National Cancer Institute where he and his team are trying to match the right patient to the right drug.Every tumor is getting sequenced. Thats accelerating the field. The sequencing techniques have gotten cheaper and faster, so we can analyze them at the point of care, Herbst says. This is why clinical trials are so important. Whats a clinical trial today is standard of care tomorrow.

In a study published in the journal Science Translational Medicine, a multi-institutional research team including a Connecticut doctor developed an advanced method to analyze existing data from thousands of clinical trials, comparing which genes FDA-approved drugs work against to the genes active in pediatric brain tumor patients. This sped up the lengthy process of developing cancer drugs.

Dr. Ching Lau, head of the oncology-hematology division at Connecticut Childrens Medical Center and the pediatric oncology-hematology department at UConn School of Medicine, is accessing the World Community Grid, an IBM-funded program that allows researchers worldwide to perform tens of thousands of virtual experiments. Instead of screening thousands and thousands of compounds to try to find a potential drug, we found we could use genomics data already available and do a more systems-approach analysis to figure out the predominant pathways driving the tumor cells, Lau, professor at The Jackson Laboratory, says in an email. Then we asked if there were any existing FDA-approved drugs that could potentially modulate those pathways.

The researchers identified eight drugs that could potentially fight medulloblastoma (MB) tumors, the most common malignant brain tumor in children. One of the drugs showed an increased survival rate in mice with MB tumors, and a clinical trial is being pursued.

Personalized medicineand heart disease

Precision medicines applications have expanded beyond cancer care. At first, much heart disease research relied on a genetic analysis of whether someone was predisposed to a disease. Thanks to a growing database of patient information that is shared worldwide, researchers can mine huge data sets with hundreds of thousands of cases for patterns and abnormalities that lead to discoveries, says Beth Taylor, associate professor of kinesiology at UConn and director of exercise physiology research in cardiology at Hartford Hospital. Researchers and clinicians know that about half the people who have heart attacks dont have the typical risk factors such as high blood pressure, obesity and diabetes. To determine why physically active people with healthy diets have heart attacks, researchers are using precision medicine to comb through large studies to find small predictors, Taylor says. Often the influence of any one factor is hard to detect unless you have a big sample size, she says.

The National Institutes of Health requires grant recipients to share their data to a national registry so that researchers have access to big data, she says. (Personal information such as date of birth, name and address are removed from files used for research studies.)

When we first began to really measure genetic variations, it was believed that was going to be the big hope in treatment, Taylor says. But genes are complex and environmental factors modify genetics for multiple generations.

For the first time ever, weve got wide-scale computing ability to analyze huge data points. This can better allow us to predict disease progression and optimize treatment, she says. Many of us would say that this concept of big data is as or more important than genetic risk. Genetic risks are not the whole picture.

For the first time ever, weve got wide-scale computing ability to analyze huge data points. This can better allow us to predict disease progression and optimize treatment.

Progress with diabetes

Precision medicine is not widely used in the treatment ofdiabetesin the U.S., except when it comes to a rare form of diabetes called neonatal diabetes mellitus. While type 1 and type 2 diabetes are controlled by two or more genesand additional genetic factors,neonatal diabetes mellitus involves a single gene and develops in babies under 6 months old.

Through genetic testing of babies with elevated blood sugar levels,researchers learnedthat about half the patients have gene mutations that respond well to a pill used to treat type 2 diabetes and they dont need to be on insulin for the rest of their lives like type 1 diabetics, says Karel Erion,director of research stewardship and communications for the American Diabetes Association.

When infants show signs of type 1 diabetes at Yale New Haven Childrens Hospital or Connecticut Childrens Medical Center, they are automatically tested for neonatal diabetes, hospital doctors say.

An example of precision medicine as a predictor of disease is the TrialNet database, which uses genetic testing to determine whether the relatives of those with type 1 diabetes have two or more of the five diabetes-related autoantibodies (proteins produced by the immune system directed against the persons own proteins) linked to increased risk of developing type 1 diabetes. Type 1 diabetics must take insulin for the rest of their lives to survive, and theres no known way to prevent the autoimmune disease. Type 1 diabetes, formerly called juvenile diabetes, typically strikes children and adolescents, causing the pancreas to stop producing insulin, a hormone needed to process sugar, or glucose, from food. Type 2 diabetes was formerly known as adult-onset diabetes, but the disorder is being seen in more children, thought to be the result of a rise in childhood obesity. Screening identifies the early stages of the disease years before any symptoms appear, according to the TrialNet website.

In a study published in the New England Journal of Medicine, researchers from the TrialNet Study Group, led by Yale Universitys Dr. Kevan Herold, found that an experimental medication delayed the onset of type 1 diabetes in high-risk participants by two years compared to the control group. The disease was diagnosed in 43 percent of the participants who received the medication, teplizumab, and 72 percent of those who received the placebo.

Alzheimers disease and dementia

Only 1 to 3 percent of the 5 million people living with Alzheimers disease have a genetic mutation that leads to whats called genetic or familial Alzheimers. But one in three older adults will eventually develop some form of dementia, says Rebecca Edelmayer, the Alzheimers Association director of scientific engagement.

Like other diseases that strike large segments of the population, researchers rely on big data to learn about Alzheimers and which genes play a role in who gets it.Researchers have learned that there are several risk factors that contribute to dementia, she says. Specifically, the presence of heart disease, high blood pressure, diabetes, social and cognitive isolation, poor nutrition and the level of education, can contribute to cognitive decline, she says.

Scientists from around the world share research data and draw from data in the Global Alzheimers Association Interactive Network, she says.The field has made some dramatic advances in understanding of how genetics play a role and how other underlying diseases play a role, Edelmayer says. We need to give doctors evidence-based recommendations.

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For cancer treatment and more, genetic-based precision medicine holds a lot of promise - Connecticut Magazine