-- Company received approval from New York State Department of Health
--
-- Expands customer base by over 19 million people --
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.
About Invitae
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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160531005532/en/
Source: Invitae Corporation