Regulatory FDA grants authorization to Invitae DNA test to identify...

FDA grants authorization to Invitae DNA test to identify cancer predisposition


The healthcare sector is undergoing rapid changes, with genetic testing leading the way in this transformation. One recet development is the granting of marketing authorization by the Food and Drug Administartion (FDA) to the Cancer Panel at InVitae.This test has been created to detect genetic predisposition to various forms of cancer.

The panel, also referred to as the Common Hereditary Cancers Panel at InVitae has extensively studied over 47 genes linked to different cancers in order to come up with an in vitro diagnostic test. These include breast, ovary, uterus, prostate, and gastrointestinal cancers. Beyond identifying potential predispositions in individuals who have not been diagnosed with cancer, this test also offers invaluable insights for those who are already battling the disease. 

By detecting cancer-associated hereditary variants, it empowers healthcare providers to make informed decisions about monitoring and treatment options. It provides individuals with greater insights into their health, potentially uncovering their genetic susceptibility to specific cancers. This newfound awareness empowers healthcare providers to customize monitoring and treatment approaches based on the identified genetic variations.

The uniqueness of InVitae’s test lies in its scale. While the genetic analysis of cancer-linked mutations is not a new concept, InVitae’s offering redefines the boundaries of what is possible. By examining 47 genes, including the well-known BRCA1 and BRCA2 genes associated with breast and ovarian cancer, as well as genes linked to Lynch syndrome and other digestive system cancers, it offers a comprehensive view of an individual’s cancer risk.

Nonetheless, it’s important to emphasize that InVitae’s test does not assess all the recognized genes linked to cancer susceptibility. Patients are encouraged to discuss their results with a genetic counselor or healthcare professional to gain a complete understanding of their genetic profile and its implications.

One of the standout features of this advancement is the rising trend in genetic testing conducted at home. The FDA has been proactive in clearing such tests for a wide range of purposes. In a recent move, the agency authorized 23andMe to report 41 additional genetic variants related to the BRCA1 and BRCA2 genes. 

This expansion of genetic testing is not unique to InVitae. Across the industry, there are over 500 genetic testing products in development, according to GlobalData. This reflects the growing importance of genetic information in shaping healthcare decisions.

It is through thorough testing that the the InVitae Common Hereditary Cancers Panel has been successful in getting the greenlight from the FDA. InVitae conducted extensive validation, testing more than 9,000 clinical samples, and achieving an impressive accuracy rate of over 99%. This high level of accuracy ensures that the test can be a reliable tool for both assessing predisposition and identifying hereditary variants in cancer patients already under treatment.

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