BioMérieux subsidiary nails Medicare coverage for breast cancer molecular test

A subsidiary of French in vitro diagnostics giant bioMérieux gained Medicare coverage for a new breast cancer test, a vital milestone necessary to compete in today's market.

San Diego-based bioTheranostics obtained coverage approval from the Centers for Medicare and Medicaid Services (CMS) for its Breast Cancer Index molecular genomic diagnostic. It's designed to quantify the risk of breast cancer recurrence, and also helps determine whether a patient will benefit from long-term endocrine (hormone) therapy. Medicare administrator Palmetto GBA conducted the evaluation and is specifically tasked with assessing molecular diagnostic technology for reimbursement. Medicare coverage will allow for use of the test to predict the risk of breast cancer recurrence within 5 to 10 years in women with early-stage estrogen receptor-positive breast cancer.

CMS coverage approval came within 8 months of commercialization efforts for the Breast Cancer Index, which usually leads the way for private insurance coverage and thus is a major win, especially now, because makers of diagnostic tests have faced struggles winning CMS or private insurance reimbursement. In the U.S., a post-Affordable Care Act environment requires companies to prove how they can manage or even reduce costs as well as boost the standard of care. Some companies have struggled to achieve both, leaving them with promising technology and a limited market because insurers resist covering their product.

Nicolas Barthelemy, bioTheranostics' president and CEO, touted in a statement that the Breast Cancer Index is "the only molecular test covered by Medicare that accurately assesses a patient's individualized risk of breast cancer recurrence after 5 years" and also has approval to screen for patients who would gain from extended hormone therapy.

In other words, personalized medicine scores again. As Barthelemy noted, the test data is designed to add a more precise diagnostic and prognostic risk assessment to the mix. BioTheranostics is pitching the test as something that will help patients avoid extended hormone therapy when they don't need it. Cancer treatment can often be heavy-handed and doesn't work the same way for every patient.

"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," Barthelemy said.

- read the release

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