Genomic Health, a provider of genomic-based diagnostic tests, will exclusively license Almac Group’s technology and intellectual property to further develop, validate and subsequently commercialize a multi-gene test to predict benefit from DNA damage-based chemotherapy drugs, such as the commonly used anthracycline-based regimens, in breast cancer.  Such a test would be particularly useful for high-risk breast cancer patients who are eligible for chemotherapy based on their Oncotype DX score. 

Genomic Health will identify a study cohort for the validation of Almac’s previously identified and published genes.  Genomic Health made an up-front payment of $9 million and will pay additional milestones. Genomic Health will pay additional royalties to Almac Group upon successful commercialization of the test.

“Working with Almac, we have the opportunity to gain further insight on the role of DNA repair in drug efficacy, which may provide clinical utility to help select which breast cancer patients benefit from specific chemotherapy drugs and regimens,” said Steven Shak, M.D., executive vice president of R&D, Genomic Health.  “Over the past 10 years, Oncotype DX has played a critical role in predicting benefit of chemotherapy, in general, for more than 400,000 estrogen-receptor positive breast cancer patients. This new test may address another unmet need by providing additional information specific to the benefit from anthracycline-based regimens for high-risk patients and possibly those with triple negative breast cancer as well.”

Anthracycline-based chemotherapy regimens are used commonly to treat breast cancer, but have significant toxicities that can be debilitating and can impact long-term quality of life.  Currently, the decision to use these therapies is based on conventional clinical and pathologic factors including age, tumor grade, tumor size and patient comorbidities. However, none of these factors accurately determines which patients will benefit from anthracycline-containing regimens.