SAN DIEGO, Calif., April 16, 2019 – Biotheranostics, Inc., announces expanded Medicare coverage for its Breast Cancer Index® (BCI) test under a new Local Coverage Determination [(LCD) L37822], effective today.
Under the new criteria, Breast Cancer Index® is covered for post-menopausal women diagnosed with early-stage, node negative, non-relapsed, ER and/or PR positive, HER2 negative breast cancer to help physicians determine treatment management of the patient for chemotherapy and/or extended endocrine therapy. The expanded coverage gives more breast cancer patients access to Breast Cancer Index genomic testing with no out of pocket financial burden for patients who meet the new LCD coverage criteria.
For hormone receptor positive (HR+) post-menopausal breast cancer patients on extended endocrine therapy, the side effects and toxicities associated with treatment often have a severe impact on health and quality of life (e.g. osteoporosis, bone fractures, joint pain). For those patients at high risk for recurrence, weighing these health risks against the potential benefit of continuing endocrine therapy beyond 5 years is essential for individual treatment planning. Thus, identifying which patients are among those for whom extending endocrine therapy helps reduce their risk of recurrence is of critical importance. Breast Cancer Index® is the only commercially-available test validated to predict which patients are likely to benefit from endocrine therapy beyond 5 years helping these patients and their physicians make appropriate decisions related to their care.
Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics, said “We are pleased that the MolDx program under the Centers for Medicare and Medicaid Services (CMS) continues to recognize the clinical utility of BCI and the strength of its clinical validation. By providing predictive and prognostic results, Breast Cancer Index® allows both patients and their physicians access to molecular information to help guide joint decision making.”
Don Hardison, Biotheranostics’ President and CEO, added, “Breast Cancer Index® has already helped thousands of women gain peace of mind with their treatment decisions beyond 5 years by providing an understanding of individual recurrence risk and whether additional treatment is likely to help reduce that risk. We are thrilled CMS has recognized the significant role of the test in extended endocrine therapy decision-making and look forward to the opportunity to provide thousands of additional patients with this valuable information.”
About Breast Cancer Index®
Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early stage, ER+ breast cancer. This breakthrough test helps oncologists and patients navigate the difficult trade-off between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. Breast Cancer Index holds guidelines designation from the American Joint Committee on Cancer for cancer staging based on molecular profile; ASCO, NCCN, European Group on Tumor Markers (EGTM), and St. Gallen to inform the chemotherapy decision; and ASCO and EGTM to inform the extended endocrine treatment dilemma. It is the only validated, commercially available test that provides risk of overall and late distant recurrence and predicts the likelihood of benefit from extended endocrine therapy. For more information, visit breastcancerindex.com.
Biotheranostics, Inc. operates a CLIA-certified and CAP-accredited diagnostic laboratory in San Diego, California. Biotheranostics, Inc., is a leading healthcare provider in the oncology field assisting physicians in the treatment of cancer patients. Its suite of proprietary molecular diagnostic tests provides important information to physicians to tailor treatment to individual patients. The company's Breast Cancer Index® and CancerTYPE ID® tests address a variety of unmet medical needs in the management of cancer patients, and extensive clinical studies have confirmed the accuracy, clinical validity, clinical utility, and cost-effectiveness of the tests. Learn more at biotheranostics.com.
BCI provides a quantitative assessment of the likelihood of distant recurrence in patients diagnosed with ER+ node-negative breast cancer, and prediction of likelihood of benefit from extended (>5 year) endocrine therapy in patients who are recurrence-free after an initial 5 years of adjuvant endocrine therapy. Treatment decisions require correlation with all other clinical findings. This test was developed and its performance characteristics determined by Biotheranostics, Inc. lt has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. lt should not be regarded as investigational or for research. How this information is used to guide patient care is the responsibility of the physician. Biotheranostics is certified under the Clinical Laboratory lmprovement Amendments of 1988 to perform high-complexity clinical laboratory testing.