The FDA also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
The firm said net product revenues fell 11 percent year over year in the fourth quarter.
The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.
Myriad CEO Mark Capone said earnings during the quarter exceeded expectations based on strong volume growth from hereditary cancer and new products.
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 market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
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.
23andMe's genetic health report is for three BRCA1 and BRCA2 mutations most commonly found in people of Ashkenazi Jewish descent.