The New York State Department of Health has approved the use of San Diego-based bioTheranostics Inc.’s Breast Cancer Index, a molecular test that determines risk of early and late recurrence and benefit from extended endocrine therapy in patients with early stage, estrogen receptor-positive breast cancer.
With this approval, bioTheranostics can perform Breast Cancer Index testing on tissue samples from patients in New York state.
“We are pleased that the Breast Cancer Index has been approved by New York state, as its Clinical Laboratory Evaluation Program is one of the most rigorous in the nation,” said Richard Ding, CEO of bioTheranostics. “Its acceptance of validation data for the Breast Cancer Index is a milestone as we focus on commercializing the test and making it widely available to oncologists and breast cancer patients looking to make more-informed practice management and treatment decisions.”
The Breast Cancer Index is the only commercially available biomarker for estrogen receptor-positive breast cancer patients that addresses unmet clinical needs by accurately predicting both early (0-5 years) and late (5-10 years) distant recurrence, as well as predicting benefit from extended endocrine therapy. Statistics show that about two-thirds of breast cancer patients are estrogen receptor positive, and the risk of late distant recurrence remains a substantial concern, with greater than 50 percent of recurrences occurring after five years in this patient group.
Ding said the ability of the Breast Cancer Index to predict which patients will truly benefit from extended endocrine treatment is significant in the context of safety concerns and side effects.
The Breast Cancer Index has been studied extensively, with clinical research data covering more than 2,200 patients and results published in more than 10 peer-reviewed publications, including pivotal studies in 2013 in The Lancet Oncology, Journal of the National Cancer Institute, and Clinical Cancer Research.