“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 de novo authorization creates a new device class, so every follow-on test can take the easier 510(k) route. The bar is 99.0% positive agreement and 99.9% negative agreement. A false negative tells a patient to skip surveillance they need. Invitae grades the variants partly against its own internal database.