SAN FRANCISCO--(BUSINESS WIRE)--Invitae Corporation (NYSE: NVTA), a genetic information company, today announced that it is releasing the next generation of comprehensive cancer panels, providing broader panels and new testing categories.
Invitae has now expanded its cancer offering to include more than 40 testing panels. This new offering includes a mix of larger panels, such as expanded test panels for hereditary breast, gynecologic, colon, and pancreatic cancers, and new panels for common hereditary cancers and gastric cancer. The new test menu also includes smaller, focused test panels, such as Lynch syndrome and hereditary breast and ovarian cancer syndrome. Invitae testing also provides detection of unusual but important mutations such as the promoter mutations in APC, BMPR1A, GREM1, PTEN, MLH1, and TP53, and previously difficult to detect alterations such as the "Boland inversion" for MSH2 and deletions or duplications in the CHEK2 and PMS2 genes. The result is a more comprehensive set of test panels with in-depth coverage of genes relevant to these hereditary cancer syndromes.
“As we’ve seen through recently published data, the use of multi-gene panel testing to assess hereditary cancer risk is an important new development in clinical oncology,” said Adam Brufsky, MD, director of Comprehensive Breast Services, Magee-Womens Hospital, University of Pittsburgh Medical Center. “Now that the Supreme Court has enabled the availability of new hereditary cancer tests, clinicians now have important new affordable options. The ability to customize a genetic panel could give clinicians the flexibility they need to select the right option for each of their patients.”
Before the end of the year, Invitae also plans to expand its offering to include additional hereditary cancer syndromes, to include hematopoietic malignancies, bone and soft tissue sarcomas, neurological, endocrine, genitourinary, and skin cancers.
Invitae recently published clinical data in the Journal of Molecular Diagnostics demonstrating in a study of approximately 1,000 patients that Invitae’s next generation DNA sequencing platform delivered 100% analytic concordance and 99.8% clinical concordance compared to genetic tests from Myriad Genetics.
“Given our expanding body of evidence demonstrating the high quality of our test results, we’re pleased to be able to make our testing available to help a broader group of patients,” said Robert Nussbaum, MD, chief medical officer of Invitae. “Expanding access to comprehensive genetic information can significantly improve care and outcomes, and we expect that payers, patients, and clinicians will recognize that genetic testing is an important component of healthcare when carried out in accordance with responsible, guidelines-based medical practice. Now, payers have the opportunity to significantly reduce healthcare costs by working with Invitae.”
Invitae offers a transparent pricing structure independent of the number of genes required to provide an accurate diagnosis for any specific clinical indication. For payers and institutions who are in contract with Invitae, the price per indication 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 indication 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 indication for patients whose clinician has ordered the testing online and who register online and pay in advance for the testing.
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 single diagnostic service comprising hundreds of genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics and other rare 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 potential benefits of genetic testing and the company’s tests to clinicians, patients and payers; the company’s expectations regarding the release of additional tests and the timing thereof; the benefits of the company’s pricing and billing policies; and the ability of the company to realize its goals, including making genetic testing more affordable and accessible to billions of people. 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 history of losses; the ability of clinical results to affect treatment decisions; 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.