-- Test offers rapid turnaround time on seven genes that may
influence surgical options and treatment decisions --
SAN FRANCISCO--(BUSINESS WIRE)--
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 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 clinical area (see website
for more details).
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 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.
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Source: Invitae Corporation