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Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The Washington Post reports on the use of genetic tests to guide antidepressant treatment.
USA Today reports that Department of Veterans Affairs is teaming up with Sanford Health to provide veterans with genetic testing.
The program is supported via a $25 million gift from philanthropist Denny Sanford and matching contributions fundraised by Sanford Health.
Data from the GUIDED study will be central to commercial payor discussions, a Medicare LCD reconsideration request, and eventually expansion into the primary care market.
The genetic testing community is having a tough time deciphering FDA's intentions based on its authorization of 23andMe’s PGx test and a recent safety alert.
Time reports that some experts have raised concerns about 23andMe's new direct-to-consumer pharmacogenetic tests.
The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
The partners are advancing a comprehensive report on how the detected PGx markers impact drug response and customized reports focusing on specific types of drugs.
A small, early-stage trial of a combination therapy for brain cancer reports favorable responses in two patients, according to the Guardian.
Nature News writes that viral genomic surveillance in the US faces systemic issues.
President Joe Biden is seeking an increase in federal spending, including higher budgets for the National Institutes of Health and Centers for Disease Control and Prevention.
In PLOS this week: sex-stratified genome-wide association study of chronic pain, sequencing data from Indigenous Mexican groups, and more.