IRVINE, CA and AMSTERDAM – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that Blue Shield of California has updated its Medical Policy 2.04.36 Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer, to include coverage of the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test.
The updated policy states: “The use of MammaPrint is considered medically necessary in women who are diagnosed with primary invasive breast cancer.”
“In the treatment of early-stage breast cancer, access to proven, objective and trusted genomic information is invaluable in enabling physicians to confidently personalize treatment decisions for their patients,” said Mark R. Straley, CEO of Agendia.
“It is estimated that almost 28,000 women in California will be diagnosed with breast cancer this year.1 The decision by Blue Shield of California to include MammaPrint in their coverage recognizes the benefits of this test in identifying those patients who could safely forgo chemotherapy, and the highest level of clinical evidence that supports it. We are looking forward to ensuring that even more women in California can now receive the increased clarity that MammaPrint can bring at a time that is often fraught with uncertainty.”
The revised coverage became effective in the state on 1 June 2017 and Agendia Inc. is now a Preferred Network Provider. 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.
The inclusion in Blue Shield of California’s coverage follows a revision from First Coast Service Options, the Medicare contractor for Florida, Puerto Rico and the Virgin Islands to include MammaPrint in its Local Coverage Determination in March 2017.
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.
More information can be found at www.blueshieldca.com/provider.
1 Siegel, R. L., Miller, K. D. and Jemal, A. (2017), Cancer statistics, 2017. CA: A Cancer Journal for Clinicians, 67: 7–30. doi:10.3322/caac.21387
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.
Daniel Gooch / Dr Lynne Trowbridge
Tel: +44 (0) 20 7866 7905