Biotheranostics Announces Inclusion of Breast Cancer Index in the National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines for Prediction of Benefit from Extended Endocrine Therapy

Press Room

January 19, 2021

Biotheranostics Announces Inclusion of Breast Cancer Index in the National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines for Prediction of Benefit from Extended Endocrine Therapy

SAN DIEGO, Calif., January 19, 2021. Breast Cancer Index (BCI) has reached an incredible milestone as a new standard of care to predict benefit from extended endocrine therapy for patients with early-stage hormone receptor positive breast cancer. The National Comprehensive Cancer Network (NCCN) Panel expanded its clinical practice guideline for breast cancer by recognizing Breast Cancer Index as the only gene expression assay for prediction of benefit from extended endocrine therapy when considering adjuvant systemic therapy. The NCCN Guideline recommendation includes both node negative and node positive patients across anti-estrogen therapies, Tamoxifen and Aromatase Inhibitors based on data from the MA.17, Trans-aTTom and IDEAL clinical studies.

Extensive validation studies demonstrate the ability of Breast Cancer Index to predict benefit from extended endocrine therapy across all three distinct therapy groups: patients treated with five years of Tamoxifen followed by five additional years with Tamoxifen; five years of Tamoxifen followed by an additional five years with an Aromatase Inhibitor; and five years of an Aromatase Inhibitor followed by an additional five years with another Aromatase Inhibitor. Breast Cancer Index is the only test of its kind recommended to predict benefit from extended endocrine therapy for early-stage hormone receptor positive breast cancer. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

Catherine Schnabel, PhD, Chief Scientific Officer stated, "Clinical guideline endorsement by the NCCN Panel marks an evidentiary milestone for the Breast Cancer Index underscoring its distinct clinical utility for women with HR+ early-stage breast cancer, and a new paradigm for the use of genomic assays to aid in endocrine decision-making. With NCCN Guidelines as the recognized benchmark for cancer policy, the positive recommendation of BCI as a predictive biomarker of extended endocrine benefit will allow increased patient access to this important genomic tool."

Don Hardison, Biotheranostics' President and CEO adds, "We are thrilled that the NCCN has recognized Breast Cancer Index as the only biomarker to inform the decision of extended endocrine therapy. This inclusion gives providers the added confidence to incorporate BCI into routine clinical practice. It also allows our organization to realize its goal to be standard of care for all early-stage HR+ breast cancer patients faced with the difficult decision of the duration of endocrine therapy."

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, HR+ 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, NCCN 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.

About Biotheranostics

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.