On October 3, 2023 Invitae (NYSE: NVTA), a leading medical genetics company, reported it gained FDA market authorization for its Common Hereditary Cancers Panel (Press release, Invitae, OCT 3, 2023, View Source [SID1234635597]). This represents the first broad panel that is used to identify germline variants associated with hereditary cancer to gain market authorization from the FDA. The company believes that this is a strong vote of confidence in its Common Hereditary Cancers Panel, which has the potential to benefit patients, providers and payers.

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Through this application, Invitae was able to establish a new category of device based on its testing technology and methodology which provides potential marketing differentiation and opportunities for its largest testing category. In 2021, the company submitted a de novo application using the Common Hereditary Cancers Panel as an example of a methods-based approach to validation. The FDA worked closely with Invitae to review the test and its supporting data, which led to this authorization being granted on September 29, 2023.

"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," said Robert Nussbaum, M.D., chief medical officer at Invitae. "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."

About the Common Hereditary Cancers Panel

The Invitae Common Hereditary Cancers Panel is an in vitro diagnostic test focused on 47 genes already known to contain tens of thousands of genetic variants that increase risk of developing certain cancers. Hereditary cancer testing represents the largest business line of Invitae’s testing portfolio, and multiple peer-reviewed studies1 published in recent years have demonstrated its clinical utility. That utility includes determining the potential risk for cancer, informing management and treatment of those with the disease and helping to prevent disease in those at increased risk. To learn more, visit our website.

Intended Use of the Market Authorization

The Invitae Common Hereditary Cancers Panel is a qualitative high throughput sequencing-based in vitro diagnostic test system intended for analysis of germline human genomic DNA extracted from whole blood for detection of substitutions, small insertion and deletion alterations and copy number variants (CNV) in a panel of targeted genes. This test system is intended to provide information for use by qualified health care professionals in accordance with professional guidelines, for hereditary cancer predisposition assessment and to aid in identifying hereditary genetic variants potentially associated with a diagnosed cancer. The test is not intended for cancer screening or prenatal testing. Results are intended to be interpreted within the context of additional laboratory results, family history and clinical findings. The test is a single-site assay performed at Invitae Corporation.