IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that First Coast Service Options Inc. (“First Coast”), the Medicare contractor for Florida, Puerto Rico, and the Virgin Islands, has revised its Local Coverage Determination (LCD-L33586) for gene expression profiling panel for use in the management of breast cancer treatment to include the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test.1 The MammaPrint test is intended to assess a patient’s risk for distant metastasis within 5 years.
“This is another significant recognition of the clinical value of MammaPrint to individualize how patients with early-stage breast cancer are treated,” said Mark R. Straley, CEO of Agendia. “We are committed to improving the quality of life for cancer patients through molecular diagnostics. The decision by First Coast to cover MammaPrint will help more breast cancer patients in Florida, Puerto Rico and the Virgin Islands to access the benefits of this valuable test, allowing many to safely forego unnecessary chemotherapy.”
The revised LCD became effective on March 17, 2017. This determination follows the peer-reviewed publication of the prospective, controlled and randomized Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) trial in the prestigious New England Journal of Medicine (NEJM)2 in August 2016, which provided the highest level of clinical evidence to support the clinical utility of MammaPrint.
Agendia’s primary focus is expanding the adoption of MammaPrint as an aid to personalizing breast cancer treatment by increasing the test’s geographic reach and reimbursement. MammaPrint is available globally through many major hospitals, providing physicians and patients access to this essential breast cancer test to enable more informed decision-making and more individualized treatment.
1 “FCSO reference LCD number-L33586: Gene
Expression Profiling Panel for use in the Management of Breast Cancer
Treatment.” CMS.gov Centers for Medicare & Medicaid Services. Web.
26 April 2017.
2 Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
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MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis within 5 years. MammaPrint also carries the CE Mark which certifies that the test complies with the quality standards set by the European In Vitro Diagnostic Directive, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.
Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include MammaPrint®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint®, a Molecular Subtyping Assay that provides deeper insight leading to more clinically actionable breast cancer biology.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology.