The Centers for Medicare & Medicaid Services has posted a positive coverage and reimbursement policy for the Breast Cancer Index by bioTheranostics, San Diego. The posting came after evaluation of the test by Palmetto GBA, the Medicare carrier responsible for the molecular diagnostic (MolDx) technology assessment program.


Nicolas Barthelemy, bioTheranostics

The Breast Cancer Index is a molecular genomic test that quantifies a patient’s risk of breast cancer recurrence and is validated to identify which patients have a high likelihood of benefitting from extended endocrine therapy. The Medicare policy determination covers use of the test to predict risk of late distant recurrence (5 to 10 years) in women with early-stage, estrogen receptor-positive breast cancer. Medicare coverage and payment for the Breast Cancer Index will cover new claims and will also be available retrospectively, for previously submitted claims.

“We are pleased that we have attained such a significant milestone within the first 8 months of full commercialization of the Breast Cancer Index,” says Nicolas Barthelemy, president and CEO of bioTheranostics. “Securing Medicare coverage is a significant achievement and will help ensure broader patient access to this important breakthrough in breast cancer management.”

Use of the Breast Cancer Index will be especially important among patients who are considering extended endocrine therapy, but are concerned because of documented toxicity or possible significant patient-specific side-effects.

“This critical information will allow many women to avoid unnecessary treatment and potential side-effects that can adversely affect their health and quality of life,” says Barthelemy. “We appreciate Palmetto GBA’s consideration and diligence in reaching this coverage decision.”


Ruth O’Regan, MD

“Women with breast cancer face difficult trade-offs between wanting to take steps to help prevent the recurrence of their disease and facing significant side-effects and costs related to extended endocrine treatments,” says Ruth O’Regan, MD, MRCPI, director of translational breast cancer research at the Winship Cancer Institute of Emory University. “The Breast Cancer Index provides important, patient-specific genomic information that helps clinicians identify patients who may not benefit from extended endocrine treatments, allowing them the choice of discontinuing therapy.

“For patients identified as at higher risk, clinicians now have information that they can use to emphasize the importance of compliance with treatment and establish appropriate follow-up,” says O’Regan. “In light of recently updated ASCO guidelines encouraging consideration of extended endocrine treatment in some breast cancer patients beyond 5 years, the coverage of this test is particularly timely.”

About two-thirds of breast cancer patients are estrogen receptor-positive, and the risk of late distant recurrence is a substantial concern, with more than 50% of recurrences occurring after 5 years. Clinical research data about the Breast Cancer Index, involving more than 2,200 patients, have been published in such peer-reviewed publications as Lancet Oncology, Journal of the National Cancer Institute, and Clinical Cancer Research.

The Medicare coverage decision was based on a review of the scientific evidence supporting the analytical validity, clinical validity, and clinical utility of the Breast Cancer Index. The determination is among the first granted to a molecular diagnostic for cancer through the rigorous MolDx evaluation process since the program was created by Palmetto GBA in 2011.

A leader in helping physicians improve the care and management of cancer patients, bioTheranostics offers a suite of proprietary molecular diagnostic tests that enable treatment to be tailored to individual patients. Based in San Diego, bioTheranostics is a bioMérieux company. For further information, visit bioTheranostics.