Test offers rapid turnaround time on seven genes that may influence surgical options and treatment decisions
Invitae Corporation (NYSE: NVTA), a genetic information company, today announced that the company now offers a new Breast Cancer STAT Panel of high-quality genetic testing designed for breast cancer patients whose providers need a fast turnaround time to guide treatment and management.
Invitae’s new Breast Cancer STAT Panel includes seven genes with surgical and therapeutic relevance: BRCA1, BRCA2, CDH1, PALB2, PTEN, STK11, and TP53. Mutations in these seven genes have been shown to increase a patient’s risk of breast cancer significantly and may influence the patient and physician choice between mastectomy and lumpectomy, whether to perform prophylactic salpingo-oophorectomy, and may inform choice of chemotherapy, including PARP inhibitors. Testing is available for blood and saliva samples, and results are available within 8-12 calendar days.
"This is the kind of patient-centered, best practice service we hope to see from a leading genetic testing lab,” said Pat Whitworth, MD, director of the Nashville Breast Center. “When making these choices, patients and their clinicians need answers quickly. The no-delay promise this policy offers patients is unprecedented and demonstrates a true commitment to patient well-being.”
Invitae’s seven-gene Breast Cancer STAT Panel has the same high quality as Invitae’s current validated, hereditary cancer tests. Data published in the Journal of Molecular Diagnostics demonstrated the analytical accuracy (100%) and clinical concordance (99.8% compared to results from Myriad Genetics) of Invitae’s methods in a study of more than 1,000 patients in collaboration with Massachusetts General Hospital and the Stanford University School of Medicine. In addition, data showing the clinical utility of the Invitae hereditary breast and ovarian cancer (HBOC) panel test was published in a companion manuscript in JAMA Oncology.
Furthermore, the panel is offered with the same affordable, transparent pricing as with all other Invitae tests and is part of a long-term program to make genetic testing more affordable and accessible while decreasing turnaround times for physicians and their patients. Physicians are also able to re-requisition additional genes of importance in cancer and access Invitae’s Clinical Consult to review a patient’s test results with a board-certified genetic counselor at no additional charge. Invitae also makes telephone genetic counseling services available to patients before and after testing by physician request.
“Time is of the essence and comprehensive information is essential when it comes to treating cancer,” said Robert Nussbaum, MD, chief medical officer of Invitae. “Knowing a patient has an inherited mutation associated with a higher risk of recurrence or the development of a cancer elsewhere could mean more aggressive surgical treatment might be advisable. Identifying patients carrying mutations in these seven genes is essential for making surgical decisions.”
Affordable, Transparent Pricing
Invitae offers a transparent pricing structure independent of the number of genes required to provide an accurate diagnosis within a single clinical area. For payers and institutions that are in contract with Invitae, the price per clinical area can be as low as $950, depending on the payer’s requirements. For third-party payers with whom Invitae is out-of-network and for non-contracted institutions, the price per clinical area is $1,500. In addition, for patients without third-party insurance coverage or who do not meet insurance criteria for coverage, Invitae offers its full test menu for $475 per clinical area (see website for more details).
Invitae Corporation'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 and panel tests today. The company currently provides a diagnostic service comprising hundreds of genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics, and other rare disease areas. For more information, visit our website at invitae.com.
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 Invitae’s STAT panel influencing surgical options and treatment decisions and Invitae’s long-term program to make genetic testing more affordable and accessible while decreasing turnaround times for physicians and their patients. 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: risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately, consistently and quickly; 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; laws and regulations applicable to the company’s business, including state licensing requirements and 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, 2016. 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