Invitae's Common Hereditary Cancers Panel Receives FDA Market Authorization.

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.

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.

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.