First-of-its-kind authorization provides potential marketing differentiation and opportunities for largest testing category
The approval is Testament to Invitae's product and lab quality. (Credit: CDC on Unsplash)
Invitae (NYSE: NVTA), a leading medical genetics company, today announced it gained FDA market authorization for its Common Hereditary Cancers Panel. 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.
“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.”
Source: Company Press Release