Invitae’s Common Hereditary Cancers Panel Receives FDA Market Authorization

Invitae, a leading medical genetics company, has announced that its Common Hereditary Cancers Panel has received market authorization from the FDA. This groundbreaking achievement marks the first broad panel used to identify germline variants associated with hereditary cancer to gain FDA approval.

The FDA’s authorization of Invitae’s Common Hereditary Cancers Panel is a testament to the company’s commitment to product and lab quality. This milestone sets a high standard for expected performance and the associated data required for future regulatory approval of similar products.

Through this authorization, Invitae has established a new category of device based on its testing technology and methodology. This provides potential marketing differentiation and opportunities for its largest testing category. The company believes that this achievement will benefit patients, providers, and payers alike.

The Common Hereditary Cancers Panel is an in vitro diagnostic test focused on 47 genes known to contain genetic variants that increase the risk of developing certain cancers. This panel represents the largest business line in Invitae’s testing portfolio and has been supported by multiple peer-reviewed studies, demonstrating its clinical utility.

The market authorization allows the Common Hereditary Cancers Panel to be used for hereditary cancer predisposition assessment and to aid in identifying hereditary genetic variants potentially associated with a diagnosed cancer. It is important to note that the test is not intended for cancer screening or prenatal testing. Results should be interpreted within the context of additional laboratory results, family history, and clinical findings.

Invitae’s mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. This FDA market authorization for the Common Hereditary Cancers Panel is a significant step towards achieving that mission. The company’s genetics experts apply a rigorous approach to data and research, ensuring accurate and actionable answers to strengthen medical decision-making.

With this milestone, Invitae solidifies its position as a trusted provider of genetic information, delivering timely results using digital technology. The company continues to innovate and expand its offerings, aiming to improve healthcare for individuals and their families.

For more information about Invitae and the Common Hereditary Cancers Panel, please visit their website.