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.
The Center for Genomic Interpretation and NSGC want payors to cover confirmatory testing for patients with positive results from 23andMe's FDA-cleared test.
The 4,000-participant study will use a digital enrollment platform and will provide free genetic testing as well as support from doctors and genetics experts.
FDA's blessing for 23andMe's test that gauges select BRCA1/2 variants has the cancer community worried about whether consumers will understand its limitations.
According to the Federal Register notice, after a first time FDA marketing authorization, manufacturers can commercialize new GHR tests without additional review.
