– First-of-its-kind authorization provides potential marketing differentiation and opportunities for largest testing category –
– Testament to Invitae’s product and lab quality –
– Sets the bar for expected performance and the associated data required for future regulatory approval of similar products –
SAN FRANCISCO, Oct. 3, 2023 /PRNewswire/ — 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.”
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.
Invitae (NYSE: NVTA) is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae’s genetics experts apply a rigorous approach to data and research, serving as the foundation of their mission to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential impact of the FDA market authorization of the company’s Common Hereditary Cancers Panel, including potential market differentiation and opportunities; the company’s belief that the FDA’s authorization is a testament to its product and lab quality; the company’s belief that the FDA’s authorization is a strong vote of confidence in its panel and has the potential to benefit patients, providers and payers; and the effect of the FDA authorization on future regulatory approval of similar products. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company’s ability to commercialize the Common Hereditary Cancer Panel that received FDA market authorization and the timing thereof; the company’s need to update the Common Hereditary Cancer Panel and its submission to the FDA; the company’s ability to grow its business in a cost-efficient manner; the company’s history of losses; the company’s ability to maintain important customer relationships; the company’s ability to compete; the company’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; risks associated with litigation; security breaches, loss of data and other disruptions; laws and regulations applicable to the company’s business; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.
1 Neal Shore et al.,Efficacy of National Comprehensive Cancer Network Guidelines in Identifying Pathogenic Germline Variants Among Unselected Patients with Prostate Cancer: The PROCLAIM Trial, European Urology Oncology, August 2023; Pat. W. Whitworth et al., Clinical Utility of Universal Germline Genetic Testing for Patients With Breast Cancer, JAMA Network Open, September 2022; Edward Esplin et al., Universal Germline Genetic Testing for Hereditary Cancer Syndromes in Patients With Solid Tumor Cancer, JCO Precision Oncology, September 2022; Sarah E. Coughlin et al., Multigene Panel Testing Yields High Rates of Clinically Actionable Variants Among Patients With Colorectal Cancer, JCO Precision Oncology, November 2022; Whitney Espinel et al., Clinical Impact of Pathogenic Variants in DNA Damage Repair Genes beyond BRCA1 and BRCA2 in Breast and Ovarian Cancer Patients, Cancers, May 2022; Pedro L. Uson Jr. et al., Germline Cancer Susceptibility Gene Testing in Unselected Patients With Colorectal Adenocarcinoma: A Multicenter Prospective Study, Multicenter Study, Clin Gastroenterol Hepatol, March 2022; N. Jewel Samadder et al., Comparison of Universal Genetic Testing vs Guideline-Directed Targeted Testing for Patients With Hereditary Cancer Syndrome, JAMA Oncology, February 2021; Piper Nicolosi et al., Prevalence of Germline Variants in Prostate Cancer and Implications for Current Genetic Testing Guidelines, JAMA Oncology, April 2019; Peter D. Beitsch et al., Underdiagnosis of Hereditary Breast Cancer: Are Genetic Testing Guidelines a Tool or an Obstacle?, J Clinical Oncology, December 2018.
SOURCE Invitae Corporation