In 125,000 de-identified Invitae customers with and without a personal or family history of cancer, 23andMe's DTC test would have missed almost 90 percent of BRCA mutations.
My Gene Counsel's confirmatory testing program is the latest example of how the healthcare system is adapting to consumers' growing appetite for genetic testing.
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.