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Medicare Expands Coverage for Hologic's Biotheranostics Breast Cancer Test

NEW YORK ─ Hologic on Monday announced that its subsidiary, Biotheranostics, has received broader Medicare coverage for its Breast Cancer Index test under an expanded Medicare local coverage determination.

Marlborough, Massachusetts-based Hologic said that the Breast Cancer Index test is now covered for postmenopausal women diagnosed with early-stage node-positive, non-relapsed, estrogen receptor and/or progesterone receptor positive, HER2 negative breast cancer. Early-stage node-positive breast cancer affects one to three axillary lymph nodes.

Previously, Medicare covered the test for patients with node-negative, non-relapsed, ER and/or PR positive, HER2 negative breast cancer.

The expanded coverage increases the availability of Breast Cancer Index testing with no cost to Medicare beneficiaries who meet the local coverage determination criteria, Hologic said. Citing National Cancer Institute data, the firm said that based on the expanded coverage, approximately 25,000 more women every year will be eligible for testing with Breast Cancer Index.

For hormone receptor positive, or HR+, postmenopausal breast cancer patients on extended endocrine therapy, the side effects and toxicities of treatment often have negative effects on health and quality of life, such as osteoporosis, bone fractures, and joint pain. As a result, knowing when extended endocrine therapy will benefit a patient is as important as avoiding the therapy when it will not make a difference, Hologic said.

"Expansion of Medicare coverage for the Breast Cancer Index test and its recent inclusion in National Comprehensive Cancer Network guidelines are major milestones toward making the test standard of care for all early-stage, HR+ breast cancer patients," Kevin Thornal, division president of diagnostic solutions at Hologic, said in a statement.

In February, Hologic closed a previously announced acquisition of San Diego-based molecular diagnostics firm Biotheranostics for approximately $230 million.