FDA Grants Market Authorization for Invitae’s Common Hereditary Cancers Panel; Marks First FDA Approved Multi-Gene Panel

Invitae (NYSE: NVTA), a medical genetics company, has received FDA market authorization for its Common Hereditary Cancers Panel. This achievement marks the first-ever authorization for a comprehensive panel designed to detect germline variants linked to hereditary cancer. The FDA has previously approved the BRACAnalysis test from Myriad Genetics which tests for only two genes (BRCA1 and BRCA2).

Invitae established a novel device category through this application and in 2021 Invitae submitted a de novo application, utilizing the Common Hereditary Cancers Panel as an example of its methods-based validation approach. The FDA collaborated closely with Invitae in evaluating the test and its supporting data, culminating in the granting of market authorization on September 29, 2023.

The Invitae Common Hereditary Cancers Panel examines 47 genes linked to increased genetic risk for various cancers, including breast, ovary, uterus, prostate, and gastrointestinal cancers (stomach, colon, rectum, small bowel, and pancreas). It is intended for individuals with a family or personal medical history of these cancers. Deleterious mutations in the genes tested can be associated with significantly higher lifetime cancer risk. Typical turnaround time for the test is 10–21 calendar days (average 14 days). It can be performed utilizing blood or a saliva buccal swab.

Robert Nussbaum, M.D., Chief Medical Officer at Invitae, expressed enthusiasm about this milestone, stating, “This is incredibly exciting news for Invitae. We were able to demonstrate that the way the technology works can be well characterized based on variant type and genomic context and is consistent across genes. The fact that we were able to do this is a testament to Invitae’s quality and rigorous validation process that met the agency’s standards.”