SAN FRANCISCO--(BUSINESS WIRE)--Invitae Corporation (NYSE: NVTA), a genetic information company, today announced that the company has completed the comprehensive Clinical Laboratory Evaluation Program and received its clinical laboratory permit from the state of New York. With this approval, Invitae now offers genetic testing in all 50 states, Canada, and other countries in the following test categories:
- Hereditary cancer: Invitae has one of the most comprehensive hereditary cancer testing menus, which includes testing for breast, gynecologic, ovarian, uterine, colorectal, gastric, pancreatic, endocrine, gastrointestinal, genitourinary, hematologic, nervous system/brain, sarcoma, and skin cancers
- Cardiology: Invitae’s cardiology menu analyzes approximately 190 genes for arrhythmias, cardiomyopathies, aortopathies, familial hypercholesterolemia, pulmonary hypertension, and congenital heart disease
- Pediatrics: Invitae has also expanded its pediatric genetics test menu. Invitae’s epilepsy panel analyzes up to 103 genes that are associated with both syndromic and nonsyndromic causes of epilepsy. Invitae also offers comprehensive gene panels for Noonan syndrome, hereditary spastic paraplegia, and primary ciliary dyskinesia
“High quality, affordable genetic testing with transparent sharing of clinical variant data is the new gold standard for 21st century genomic medicine. We’re pleased to receive approval from New York State for over 600 genes which will now be available to more than 19 million people,” said Randy Scott, chairman and CEO of Invitae. “This comprehensive and rigorous review process, along with our accreditation by the College of American Pathologists (CAP), represents the high caliber we’ve set in terms of our quality. We’re proud of this accomplishment and look forward to working with the New York State Department of Health to expand this license to our other panels in neurology, pediatrics, and other rare diseases while lowering the cost of genetic testing for patients, physicians, and payers in the state of New York.”
Invitae is a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified clinical diagnostic laboratory.
High quality genetic testing is now affordable
This past year, Invitae published data directly comparing traditional and multi-gene panel testing in more than 1,000 patients in The Journal of Molecular Diagnostics. The published data show that Invitae’s next generation DNA sequencing platform achieves high sensitivity and specificity compared to traditional genetic tests from other labs. In a more recent study presented at the 2016 ACMG Annual Clinical Genetics Meeting, Invitae compared publicly available classifications of variants in BRCA1 and BRCA2 across seven established clinical laboratories. The study found a high concordance rate of 98.5% for classifications of BRCA1 and BRCA2 variants across labs.
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 that 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 orders 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 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 ir.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 the company’s licensing of additions to its test menu in New York, the continued quality of its services and potential sales of its testing services in New York. 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 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 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 Annual Report on Form 10-K for the year ended 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.