Invitae has achieved a significant milestone with the FDA granting de novo clearance for its groundbreaking blood test. This test is designed to identify hundreds of potential genetic markers, offering invaluable insights into an individual’s increased susceptibility to a variety of specific cancers.
While the practice of scrutinizing DNA for cancer-related mutations is not new to the diagnostics field, Invitae’s test introduces a new era in genetic assessment due to its unprecedented scale, as highlighted by the FDA in its announcement.
“This 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. Today’s action can provide an important public health tool that offers individuals more information about their health, including possible predisposition for certain cancers, which can help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants.”
– Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health
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Invitae’s innovative offering, known as the Common Hereditary Cancers Panel, examines 47 genes, including BRCA1 and BRCA2, associated with hereditary breast and ovarian cancer. It also investigates genes linked to Lynch syndrome, which can trigger various tumor types, including colorectal cancer. Additionally, the test provides insights into specific digestive system cancers, such as diffuse gastric cancer, and tumors associated with Peutz-Jeghers Syndrome.
The FDA emphasized that this prescription-only test does not comprehensively evaluate all known cancer predisposition genes. Consequently, patients are advised to discuss their test results with a genetic counselor or healthcare professional. Invitae conducted extensive validation, testing over 9,000 clinical samples, achieving a remarkable accuracy rate of greater than 99% for the panel’s performance. Furthermore, the test is valuable in identifying potentially hereditary variants in patients who have already received a cancer diagnosis.
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Invitae’s achievement is a significant leap forward in personalized medicine, offering individuals critical insights into their genetic predisposition to cancer and paving the way for more informed healthcare decisions and interventions.
