Fda warns testing companies: don’t tell patients how their dna influences response to specific drugs
Fda warns testing companies: don’t tell patients how their dna influences response to specific drugs"
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Amid a boom in genetic testing that aims to predict a person’s response to medication, the Food and Drug Administration has been quietly pressuring a handful of companies to stop reporting
results to patients about how their genes may interact with specific drugs. The agency’s concern? That unsupported claims about gene-drug links could be dangerous, if they spur patients to
start, stop, or switch medications in ways that aren’t appropriate. Myriad Genetics saw its stock fall earlier this month after reporting to investors that the FDA wanted changes to its
so-called pharmacogenetic test. Color, OneOme, and Genomind — all of which offer such tests ordered by a physician — confirmed to STAT that they recently made changes in how they report
these test results in response to back-channel conversations with the FDA. STAT+ Exclusive Story Already have an account? Log in THIS ARTICLE IS EXCLUSIVE TO STAT+ SUBSCRIBERS UNLOCK THIS
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Fda warns testing companies: don’t tell patients how their dna influences response to specific drugsAmid a boom in genetic testing that aims to predict a person’s response to medication, the Food and Drug Administration ...
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