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The company beat the consensus Wall Street estimate on the top line but narrowly missed it on the bottom line.
The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
The firm can now tell customers if their genotypes may impact their response to clopidogrel and citalopram without the need for confirmatory testing.
The Helsinki-based firm is making its panel available for free to people who already have been genotyped by consumer genomics services or biobanks.
The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.
23andMe customers who have one of three common variants identified in reports can choose six family members to receive health and ancestry test kits.
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.