bioTheranostics Receives Approval to Perform Breast Cancer Index Testing for Patients in State of New York
SAN DIEGO--(BUSINESS WIRE)--bioTheranostics, Inc., a leading provider of genomic solutions for cancer patients, today announced that the New York State Department of Health has approved the use of its Breast Cancer IndexSM, 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 now perform Breast Cancer Index testing on tissue samples from patients in New York State.
“And aromatase inhibitors such as letrozole and exemestane are known to cause cumulative bone loss that can lead to osteoporosis and fractures. Women on endocrine treatments also often suffer from substantial tolerability challenges, such as hot flashes, vaginal discharge, joint stiffness, and gastrointestinal issues.”
Richard Ding, CEO of bioTheranostics, said, “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. 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 the majority (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. “Extended tamoxifen treatment is known to double the risk of endometrial cancer, ischemic heart disease, and pulmonary embolism over a five-year period,” Ding said. “And aromatase inhibitors such as letrozole and exemestane are known to cause cumulative bone loss that can lead to osteoporosis and fractures. Women on endocrine treatments also often suffer from substantial tolerability challenges, such as hot flashes, vaginal discharge, joint stiffness, and gastrointestinal issues.”
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.
bioTheranostics, Inc., is the leading solution provider for early stage breast cancer and a broad range of metastatic cancers, leveraging its unique expertise in gene expression profiling to develop a growing array of molecular diagnostic tests for cancer. The company operates a CLIA-certified, CAP-accredited diagnostic laboratory to perform its proprietary tests: the Breast Cancer IndexSM, which quantifies risk of early and late recurrence of estrogen receptor-positive breast cancer, and the bioT3 Metastatic Cancer Solution suite of tests, which includes CancerTYPE ID® and CancerTREATMENT ID. bioTheranostics, a bioMérieux company, is based in San Diego. Learn more at biotheranostics.com.