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The US Food and Drug Administration has raised questions about whether Myriad Genetics' GeneSight test can help tailor antidepressant use, Bloomberg reports.

It adds that Myriad revealed in a securities filing that the regulatory agency had asked it to revamp its test. As GenomeWeb has reported, FDA has signaled its intent to strengthen its oversight of pharmacogenetic tests. For instance, it sent a warning letter to Inova Health System about its pharmacogenetic testing service earlier this year.

Stephanie Caccomo, an FDA spokesperson, tells Bloomberg that the agency "is looking into the marketing of pharmacogenetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic variations and the medication’s effects has not been established and is not described in the drug labeling."

According to GenomeWeb, Myriad has provided FDA with clinical evidence and other information on its GeneSight test and is in ongoing discussions with the agency. But Myriad notes, that it "cannot predict with certainty the outcome of our interactions with the FDA or its timing, and whether the ultimate form of the test offering will have an adverse effect on our revenues from the test," according to Bloomberg.