23andMe gets FDA approval for another direct-to-consumer cancer test

Julie Spitzer - Print  | 

Direct-to-consumer genetic testing company 23andMe will soon be able to offer consumers a DNA test for a hereditary colorectal cancer syndrome, thanks to its latest FDA clearance, Chicago Tribune reports.

Three things to know:

1. The test will analyze 23andMe customers' DNA for two genetic variants that influence MUTYH-associated polyposis, a rare condition linked with an increased risk of colorectal cancer.

2. Hereditary colorectal cancers make up just 5 percent of all colorectal cancer cases. 23andMe's new test doesn't look for genetic variants associated with Lynch syndrome, the most common form of inherited colorectal cancer.

3. This marks 23andMe's second FDA-cleared test that assesses cancer risk. In March 2018, 23andMe began offering a test that reports on mutations in two genes, BRCA1 and BRCA2, which are associated with an increased risk of breast cancer.

More articles on supply chain:

Verily's smartwatch gets FDA clearance for EKG: 4 things to know
Intalere taps Medline for lab distribution services
The first generic of Sabril, a heart device for premature babies, and 2 more FDA approvals

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.