Medicare Insurance Coverage for Breast Cancer Index™ Test Expanded to Include Node-Positive Breast Cancer
May 10 2021 - 4:02PM
Business Wire
-- More women gain access to a test that helps
determine whether extended endocrine therapy is appropriate for
them --
Hologic, Inc. (Nasdaq: HOLX) announced today that its
subsidiary, Biotheranostics, Inc., has received broader Medicare
coverage for its Breast Cancer Index™ test under an expanded
Medicare Local Coverage Determination (LCD: L37822) effective
today.
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the full release here:
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Under the new criteria, the Breast Cancer Index™ test is now
covered for post-menopausal women diagnosed with early-stage
node-positive (one to three axillary lymph nodes), non-relapsed,
estrogen receptor (ER) and/or progesterone receptor (PR) positive,
HER2 negative breast cancer to help physicians manage treatment of
the patient. Previously, Medicare covered the test only for
patients with node-negative, non-relapsed, ER and/or PR positive,
HER2 negative breast cancer. Therefore, the expanded coverage
increases the availability of Breast Cancer Index testing with no
cost to Medicare beneficiaries who meet the LCD criteria.
“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,” said Kevin
Thornal, division president, Diagnostic Solutions at Hologic.
For hormone receptor positive (HR+) post-menopausal breast
cancer patients on extended endocrine therapy, the side effects and
toxicities of treatment often have significant 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 it when
it will not make a difference. The Breast Cancer Index test can
help personalize extended endocrine treatment for all HR+
early-stage patients.
The ratio of breast cancers diagnosed as node-negative or
node-positive varies year to year, but according to data published
by the National Cancer Institute1 in 2021, approximately 85% of
early-stage, HR+ breast cancers were node-negative and 15% were
node-positive that year. This means that approximately 25,000 more
women every year will be eligible for testing with Breast Cancer
Index based on the expanded coverage.
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-offs between taking steps to
prevent recurrence of their disease and facing significant side
effects and safety challenges related to unnecessary treatment.
Breast Cancer Index has guideline designation from the American
Joint Committee on Cancer for cancer staging based on molecular
profile. ASCO, NCCN, the European Group on Tumor Markers (EGTM) and
St. Gallen acknowledge Breast Cancer Index as a biomarker to inform
the chemotherapy decision; ASCO, NCCN and EGTM to inform the
extended endocrine treatment decision. It is the only validated,
commercially available test that predicts benefit from extended
endocrine therapy. Breast Cancer Index is intended for routine
clinical use, and treatment decisions based on results are the
responsibility of the physician. It is a laboratory developed test
(LDT) performed in a CLIA-certified and CAP-accredited diagnostic
laboratory and is not required to be cleared or approved by the US
Food and Drug administration. For more information, visit
www.breastcancerindex.com.
About Hologic
Hologic, Inc. is an innovative medical technology company
primarily focused on improving women’s health and well-being
through early detection and treatment. For more information on
Hologic, visit www.hologic.com.
Forward-Looking Statements
This press release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of the Breast Cancer Index test. There can be no assurance this
test will achieve the benefits described herein or that such
benefits will be replicated in any particular manner with respect
to an individual patient. The actual effect of the use of the test
can only be determined on a case-by-case basis depending on the
particular circumstances and patient in question. In addition,
there can be no assurance that this test will be commercially
successful or achieve any expected level of sales based on the
expanded Medicare coverage. Hologic expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any such statements presented herein to reflect any
change in expectations or any change in events, conditions or
circumstances on which any such statements are based.
Hologic, Breast Cancer Index, CancerType ID and The Science of
Sure are trademarks and/or registered trademarks of Hologic, Inc.
in the United States and/or other countries.
SOURCE: Hologic, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210510005802/en/
Investor Contact Michael Watts Vice President, Investor
Relations and Corporate Communications (858) 410-8588
michael.watts@hologic.com
Media Contact Jane Mazur Vice President, Divisional
Communications (585) 355-5978 jane.mazur@hologic.com
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