The FDA has approved the first blood test that can help identify hundreds of potentially cancer-associated hereditary variants. The Invitae Common Hereditary Cancers Panel evaluates a blood sample to identify DNA variants in 47 genes associated with an elevated risk of developing certain types of cancer.

The agency has granted de novo marketing authorization for the test, which creates a new regulatory classification. Subsequent devices of the same type may go through FDA’s 510(k) premarket process for marketing approval. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. For example, accuracy for reporting of substitutions, insertions/deletions, and copy number variants must be ≥99.0% for positive agreement and ≥99.9% for negative agreement with a validated orthogonal method.

“This [Invitae’s] test can assess multiple genes in a single test by using next-generation sequencing, which has proven helpful in providing insight into genetic variants with sensitivity and speed,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

According to the Centers for Disease Control and Prevention (CDC), there are more than 100 different types of cancer, which is the second leading cause of death in the US behind heart disease. Meanwhile, the number of hereditary cancer variants identified has steadily increased, as well as the number of tests for them. But there is not much of an increase in testing for these.

In a recent presentation at ASCO, a resear