Study demonstrates that Invitae's multi-gene test yields clinically actionable findings for substantially more patients than does traditional single-gene testing
SAN FRANCISCO – Invitae Corporation (NYSE: NVTA), a genetic information company, announced that new data will be presented during the 51st American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation, “Clinical Impact of Multi-Gene Panel Testing for Hereditary Breast and Ovarian Cancer Risk Assessment” (Abstract 1513), will be presented as a poster discussion on Monday, June 1 by Leif W. Ellisen, MD, PhD, program director of breast medical oncology at Massachusetts General Hospital and professor of medicine at Harvard Medical School.
The study was conducted as a collaboration between Invitae, Massachusetts General Hospital, the Stanford University Cancer Institute and Beth Israel Deaconess Medical Center. The goal of the study was to evaluate the clinical utility of multi-gene hereditary cancer tests in a representative patient population meeting appropriate criteria for BRCA1/2 testing. More than 1000 BRCA1/2-negative individuals were tested using a 29- or 25-gene panel, and, for those who carried non-BRCA mutations, the patient care implications of these findings were assessed under uniform criteria based on current oncology practice guidelines.
“For patients without BRCA1/2 mutations, management has traditionally been guided by personal and family history alone, even though it is now well known that mutations in other cancer-risk genes are present in some of these patients,” said Dr. Ellisen. “Our study is among the first to systematically investigate the clinical utility of the new generation of hereditary cancer tests. We find that multi-gene panels yield clinically relevant findings with potentially beneficial management implications for substantially more patients than does BRCA1/2 testing alone.”
The investigators found that the majority of non-BRCA positive results would warrant consideration of a change in care for the patient, over and above any actions that would be considered based on family history alone. Moreover the study showed that genetic testing of family members would also be warranted given the management implications that would be considered for relatives found to be positive for non-BRCA genes.
Invitae’s (NYSE: NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Currently focused on hereditary cancers, Invitae’s goal is to aggregate most of the world’s genetic tests into a single service with higher quality, faster turnaround time and lower price than many single-gene tests today. The company currently provides a single diagnostic service comprising over 200 genes for a variety of genetic disorders associated primarily with cancer, but also covering cardiology, hematology, neurology and pediatrics.
Safe Harbor Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of multi-gene panels as compared to BRCA 1/2 testing alone; and the company’s belief that it can accelerate the adoption of comprehensive genetic information into mainstream medical care and realize its mission. 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 results of clinical studies; the applicability of clinical results to actual outcomes; the company’s history of losses; the company’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company’s ability to develop and commercialize new tests and expand into new markets; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; the company’s ability to compete; laws and regulations applicable to the company’s business, including potential regulation by the Food and Drug Administration; 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 March 31, 2015. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.
NOTE: Invitae and the Invitae logo are trademarks of Invitae Corporation. All other trademarks and service marks are the property of their respective owners.
Source: Invitae Corporation