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pharmacogenetics

Though the test is already commercially available, the firm met with the FDA last year to discuss plans for a randomized controlled trial to support regulatory approval.

How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.

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.

PGx Philanthropy

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.

Few Eyebrows Up

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.

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Australia will not be regulating gene editing of plants, animals, and human cell lines as long as no new genetic material is incorporated, reports Nature News.

The Washington Post reports that the US Department of Agriculture told its researchers to label peer-reviewed articles as "preliminary" work.

Researchers have sequenced the genomes of both the coast redwood and the giant sequoia, according to the San Francisco Chronicle.

In PNAS this week: study of epigenetic patterns in mammalian eggs, clonal expansion patterns in CD8+ T cells, and more.