FDA Gives De Novo Authorization for DNA Test for Hundreds of Cancer Variants

Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo marketing authorization by the FDA.

The Common Hereditary Cancers Panel can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The first of its kind to be granted FDA marketing authorization, the test evaluates DNA to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer. 

To validate the test’s performance, Invitae tested over 9,000 clinical samples, and achieved 99 percent accuracy for all tested variant types. The risks associated with the test are the possibility of false positive and false negative test results, as well as possible misunderstanding of the results.

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