Invitae Corporation (NYSE: NVTA), a genetic information company, and its collaborators announced the publication of new data describing the clinical actionability of multi-gene testing for hereditary breast and ovarian cancer (HBOC) risk in JAMA Oncology. The study was a collaboration among Massachusetts General Hospital, Harvard Medical School, Stanford University, Beth Israel Deaconess Medical Center and Invitae.
In this paper, more than 1,000 patients were tested with multi-gene panels, and the clinical actions that would be considered were reviewed for all 63 patients testing positive for cancer genes other than BRCA1 or BRCA2. For more than half of these patients, the genetic test would suggest a change in care over and above any recommendations based on the patient’s personal and family history alone. For these patients’ family members, testing would be warranted, as over 70% would have a change in care considered if also found to be mutation positive.
“Multi-gene panel testing for hereditary cancer risk is an important new development in clinical oncology and in clinical genetics practice,” said Leif W. Ellisen, MD, PhD, program director of breast medical oncology at Massachusetts General Hospital, professor of medicine at Harvard Medical School and senior author of the paper. “Our study examined a large, clinically representative population and showed that positive panel test results will often warrant consideration of a change in management for the patient under current medical guidelines, certainly more often than is true for BRCA1 and BRCA2 testing alone.”
The study authors followed the most recent recommendations from the National Comprehensive Cancer Network (NCCN) and other applicable consensus guidelines to determine patient care recommendations. All patients were prospectively accrued and all met appropriate criteria for HBOC evaluation. In the vast majority of positive cases (92%), the patients and/or their family members’ cancers were consistent with the scientifically well-established effects of the gene they carried, indicating that these panel test results are clinically relevant and not incidental findings.
“Expanding access to comprehensive genetic information can significantly improve care and outcomes,” said Dr. Robert Nussbaum, chief medical officer at Invitae. “I expect that payers, patients, and clinicians will recognize that this study, as well as the data recently published in The Journal of Molecular Diagnostics, provide additional evidence that genetic testing is an important component of healthcare when carried out in accordance with responsible, guidelines-based medical practice.”
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. 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 more than 200 genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics, hematology, and other disease areas.
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 company’s belief that multi-gene panel testing is an important new development in clinical oncology and in clinical genetics; that positive panel test results will often warrant consideration of a change in management for the patient as compared to BRCA1 or BRCA2 results; and the ability of comprehensive genetic information to significantly improve care and outcomes for people around the world. 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 ability of clinical trial results to affect treatment decisions; 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 generate substantial 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 June 30, 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