Friday, the FDA granted de novo approval for Invitae Corporation's NVTA Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers.
The test can also help identify cancer-associated hereditary variants in individuals with already-diagnosed cancer.
The test, the 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 over 9,000 clinical samples to validate the performance and achieved ≥99.0% accuracy for all tested variant types.
The FDA said that along with the authorization, it established special controls defining the labeling and performance testing requirements.
The accuracy for reporting base substitutions, indels, and copy number variants, for example, must be greater than 99 percent for positive agreement and greater than 99.9 percent for negative agreement with a validated orthogonal method.
The authorization of Invitae's test also creates a new regulatory classification, the FDA said, meaning that future tests of the same type and with the same intended use may use the agency's 510(k) premarket process, where test makers can obtain marketing authorization by demonstrating substantial equivalence to the Invitae test.
Price Action: NVTA shares are up 13.70% at $0.69 on the last check Monday.
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