The FDA approved Invitae Corporation's NVTA Common Hereditary Cancers Panel on Friday, an in vitro diagnostic test that can detect hundreds of genetic variants associated with an elevated risk of developing certain cancers.
The test can identify cancer-related hereditary variants in individuals with already-diagnosed cancer.
The test, first to be granted FDA marketing authorization, evaluates DNA extracted from a blood sample to identify variants in 47 genes associated with an elevated risk of developing certain types of cancer.
Invitae tested more than 9,000 clinical samples to verify the performance and achieved 99.0% accuracy for all tested variant types.
along with the authorization, the FDA established special controls defining the labeling and performance testing requirements.
For example, the accuracy for reporting base substitutions, indels, and copy numbervariantes must be more than 99 percent for positive agreement and greater than 99.9 percent for negative agreement with a validated orthogonal method.
The FDA said that the authorization of Invitae's test also creates a new regulatory classification, meaning that future tests of the same type and with the same intended use may use the agency's 510 premarket process, where test makers can obtain marketing authorization by demonstrating substantial equivalence to the Invitae test.
NVTA shares rose 13.70% yesterday to close at $0.69.