Invitae and TME Research Announce Landmark New Study to Evaluate Universal Genetic Testing of Breast Cancer Patients
December 08 2016 - 7:30AM
Business Wire
Invitae Corporation (NYSE:NVTA), a genetic information company,
and TME Research, LLC today announced the initiation of a new
clinical collaboration to evaluate the benefits of universal
genetic testing of breast cancer patients. TME Research represents
more than 300 breast care practices around the country whose core
mission is to improve the quality and access to targeted breast
cancer care.
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The collaboration, called the Universal Breast Cancer Genetic
Testing Registry, will enroll 1,000 breast cancer patients across
20-25 TME practices in the United States. The enrollees will be
tested with Invitae’s multi-cancer panel, an 80-gene hereditary
cancer test that includes genes associated with hereditary cancers
in eight major organ systems. Any patient with a current or
previous diagnosis of breast cancer will be asked to consent to be
enrolled in the study and receive genetic testing regardless of
whether they meet established testing criteria. The goal of the
study is to gather clinical and genetic information on every
patient to better clarify the prevalence of gene alterations
associated with breast cancer, the relationship of specific
alterations with clinical presentation, and the impact of genetic
information on clinical care and genetic counseling of the
family.
“The biggest revolution in medicine will be in genetic testing,
and it is starting in the cancer realm with breast cancer patients.
Universal genetic testing of breast cancer patients will reveal the
true component that genetics has in breast cancer development,”
said Peter Beitsch, MD, TME principal and former president of the
American Society of Breast Surgeons. “This will not only benefit
patients but also entire families – both male and female relatives
– since deleterious genetic mutations associated with breast cancer
can lead to many different cancers including prostate cancer.”
Emerging research suggests current guidelines may be too narrow
in their recommendations for genetic testing for breast cancer
patients and their family members. Under current guidelines, those
who do not meet specified criteria but may benefit from genetic
information rarely receive testing. Genetic information can inform
cancer treatment decisions and can help patients’ families better
understand their risk for developing breast and a variety of
cancers.
“This Universal Registry will be a landmark trial that we hope
will help lead to the revision or removal of restrictive guidelines
that were developed when genetic testing was considerably more
expensive,” noted Dr. Beitsch.
Study enrollment is expected to begin in the first quarter of
2017.
“Genetic information can help guide surgical and other treatment
decisions for all breast cancer patients. As testing becomes more
affordable and accessible, more patients should have the
opportunity to benefit from understanding their genetic
information,” said Robert Nussbaum, MD, chief medical officer of
Invitae. “Invitae is pleased to partner with TME Research on this
important study to better understand how frequently germline
mutations occur in breast cancer and how that knowledge can be used
to improve clinical management for all breast cancer patients and
their families.”
This study represents the second clinical collaboration between
Invitae and TME Research focused on increasing access to hereditary
cancer testing for patients with breast cancer and improved
clinical support models for healthcare practitioners.
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.
About TME Research
TME is a network of clinicians, researchers and educators
comprising over 300 clinical practices whose core mission is to
improve the quality and access to targeted breast cancer care by
fostering high quality and comprehensive educational programs and
resources. TME research is an extension of the TME mission and
designs, executes and optimizes accrual in breast cancer and breast
health studies with a focus on performing these studies with
community leaders. TME is headquartered in Allentown, PA. For more
information, visit http://www.tmeded.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 that genetic testing will
benefit cancer patients and their entire families; that genetic
information can inform and guide cancer treatment decisions and
help patients’ families understand their risk for developing breast
and a variety of cancers; that the Universal Registry will be a
landmark trial that will help lead to the revision or removal of
restrictive guidelines regarding genetic testing recommendations;
and that study enrollment is expected to begin in the first quarter
of 2017. 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 September 30, 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
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Invitae CorporationLaura D’Angelo,
314-920-0617pr@invitae.com
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