Invitae And TME Research Announce Landmark New Study To Evaluate Universal Genetic Testing Of Breast Cancer Patients

SAN FRANCISCO--(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.

“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”

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