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Invitae, TME Research Plan Study of Universal Breast Cancer Genetic Testing

NEW YORK (GenomeWeb) – Invitae and TME Research said today that they have begun a new clinical collaboration in which they plan to evaluate the benefits of universal genetic testing of breast cancer patients.

The project, called the Universal Breast Cancer Genetic Testing Registry, will enroll 1,000 breast cancer patients across 20 to 25 TME breast care practices in the United States. Invitae will then test the enrollees using its 80-gene multi-cancer hereditary cancer test, regardless of whether they meet current breast cancer genetic testing criteria for risk factors like age and family history.

The partners hope that the results will better clarify the overall prevalence of breast cancer gene alterations, the relationship between specific alterations and their clinical manifestation, and the impact of genetic information on clinical care for patients and family members.

If the data suggests that individuals who would not be tested under current guidelines do gain some benefit from their genetic results — either directly, or via information important to the health of their family — the study could also help lead to revision or removal of restrictive guidelines, TME principal Peter Beitsch said in a statement.

"This [could] 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," Beitsch added.

Patient enrollment is set to begin in the first quarter of 2017.