|Moderna, Pfizer Coronavirus Vaccines Begin Final-Stage Testing|
“Two of the most advanced experimental coronavirus vaccines entered the pivotal phase of their studies on Monday,” Peter Loftus and Jared S. Hopkins report for The Wall Street Journal. “The start of the pivotal Moderna vaccine trial is the latest sign that the most advanced coronavirus vaccine candidates are moving into the final stages of testing, and could be ready for wider use before year’s end if results are positive.”
President Trump visited a biotechnology plant in North Carolina yesterday, where he praised the rapid progress toward a vaccine being made under Operation Warp Speed.
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WATCH: “We’ve shaved years off” time it takes to develop a vaccine
“It doesn’t get more heartbreaking—soul-wrenching—than the funeral of tiny Davell Gardner, the youngest victim of New York City’s crime spike . . . And [criminals] now believe—alas, with good reason—that the [New York City] police and the rest of the law-enforcement system are helpless to stop them,” the New York Post editorial board writes.
The critics have it “100 percent wrong”—the Department of Homeland Security’s actions in Portland “should just be the first step in disrupting the organized violence aimed at intimidating public officials, injuring law enforcement officers, destroying public and private property and making our streets less safe,” James Jay Carafano writes for Fox News.
Ivanka Trump joined Interior Secretary David Bernhardt to visit “Duluth Pack, a Minnesota manufacturer that pivoted from leather and canvas products to [personal protective equipment] during the coronavirus pandemic, as part of her Pledge to America’s Workers that focuses on job training,” Evie Fordham writes for Fox Business.
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NIH funds genetic counseling resource ahead of million-person sequencing effort
August 21, 2019
Genetic counseling and technological infrastructure for the All of Us Research Program to be provided by Color
The All of Us Research Program, part of the National Institutes of Health, has awarded $4.6 million in initial funding to Color, a health technology company in Burlingame, California, to establish the program’s nationwide genetic counseling resource. With the goal of speeding up health research breakthroughs, All of Us plans to sequence the genomes of 1 million participants from diverse communities across the United States. Through this funding, Color’s network of genetic counselors will help participants understand what the genomic testing results mean for their health and their families.
“Returning results in a responsible way is integral to what All of Us stands for,” said All of Us Director Eric Dishman. “Participants are our partners in research, who may want to receive their own health data, including genomics. The genetic counseling resource will help our participants interpret and act upon their health information.”
As one of the most ambitious research programs in history, the All of Us Research Program aims to create the largest and most diverse health research resource of its kind. Participants from all parts of the country share health information over time through surveys, electronic health records and more. Some participants also are invited to contribute blood and urine samples for analysis. Researchers will be able to use this data to learn more about how biology, behavior and environment influence health and disease, which may lead to discoveries on how to further individualize health care in the future.
This award is in addition to Color’s ongoing funding in collaboration with the Broad Institute and Harvard’s Laboratory of Molecular Medicine, Cambridge, Massachusetts, which together received one of the three All of Us genome center awards announced in September 2018. As centers prepare to begin genotyping and whole genome sequencing in coming months, participants will be able to decide whether to receive test results.
Over time, the program anticipates providing several kinds of information to participants, including: information on ancestry and traits, drug-gene interactions (pharmacogenomics) and genetic findings connected with high risk of certain diseases. Genomic results from All of Us, although produced at a high quality in specially certified labs, should be confirmed by a health care provider before a participant makes any changes to their care. The pharmacogenomic information may help participants work with their health care teams more effectively to make choices about certain prescription drugs. Genetic findings tied to 59 genes associated with risk of specific diseases, like breast cancer or heart disease, for which there are established medical guidelines for treatment or prevention will also be returned to participants. To ensure that the program uses the most current knowledge in the fast-moving field of clinical genetics, All of Us is following guidance from professional organizations such as the American College of Medical Genetics and Genomics and the Clinical Pharmacogenetics Implementation Consortium.
As health-related information is made available, all participants will have access to genetic counseling services from Color. A small percentage of people will have DNA results, such as a variation in the breast cancer gene BRCA1, that may be important for treatment or screening. This information can also be valuable to their immediate family members who may share the same genetic variant. For All of Us, that could amount to tens of thousands of participants out of its eventual 1 million. Color will deliver the results to these participants in genetic counseling sessions, highlighting any important findings they may want to discuss with a health care provider.
“A genetic counseling award of this size is a first for NIH,” said Brad Ozenberger, Ph.D., genomics program director of the All of Us Research Program. “We look forward to working with Color and our entire consortium to discover the ethical and effective ways to deliver genetic counseling at this very large scale across diverse communities.”
Color will offer educational materials and telecounseling in multiple languages, as well as access to in-house licensed clinical pharmacists who can help participants have more effective conversations with their health care providers. Genetic counselors will also be able to help connect participants to health care providers who can address their particular health risks.
To help guide its genetic counseling services, Color’s steering committee is led by Amy Sturm, M.S., CGC, LGC, president of the National Society of Genetic Counselors. It also includes leadership of the American Board of Genetic Counseling. The steering committee will help ensure that Color delivers top-quality genetic counseling and serves as a platform for training future generations of genetic counselors.
Color has built software and digital tools that remove traditional barriers to genetic counseling and clinical genetic testing. It has conducted more than 15,000 genetic counseling sessions to help people across the country understand their DNA information.
“The All of Us Research Program is a prime example of using technology to support geographically distributed and diverse research volunteers,” said Othman Laraki, chief executive officer of Color. “This ambitious program relies on a deeply unified process, which includes engaging participants, gathering health information, sequencing genomes, interpreting data and securely and responsibly returning results. We are honored to provide the technological backbone—software and services including our genetic counseling program—to extend the reach of this groundbreaking effort across all 50 states and showcase a scalable model for the integration of genomics into public health.”
The All of Us Research Program Genetic Counseling Resource is supported by NIH award number OT2 OD028251.
All of Us Research Program Establishes Genetic Counseling Resource
About the All of Us Research Program: The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. The program will partner with one million or more people across the United States to build the most diverse biomedical data resource of its kind, to help researchers gain better insights into the biological, environmental, and behavioral factors that influence health. For more information, visit www.JoinAllofUs.org and www.allofus.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
- Precision Medicine Initiative Working Group Final Report. pdf | 1.05 mb
- NEJM Special Report: The All of Us Research Program
- What do we hope to learn?
- What would be expected of me if I enroll in the All of Us Research Program?
- Will my health information be safe? How do you plan to ensure privacy? What about data security?