The Cancer Journal documented 25 cases where inappropriate tests were ordered, variants were interpreted incorrectly, and wrong results were reported to patients.
While the FDA has expressed concerns about PGx testing, CEO Erik Hennings said the company has taken measures to limit the risk of consumer harm.
23andMe customers who have one of three common variants identified in reports can choose six family members to receive health and ancestry test kits.
Patients within the project and their physicians will be able to access Genome Medical's genetic specialists to address concerns and incorporate genetic information into care.
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 new channel, to be launched in the second quarter, is part of the company's plan to make genetic testing affordable and accessible to everyone.
In an effort to lift patient access barriers, the company is launching a model whereby consumers will be able to initiate test orders online.
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.