January 9, 2019
Positive Assessment Issued for Agendia’s MammaPrint®
- Determination finds that Agendia’s MammaPrint® Breast Cancer Risk of Recurrence test improves net health outcome for patients and positions the test well for further adoption by health insurance plans in the U.S.
IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – 9 January 2019 – Agendia, Inc., a world leader in precision oncology, announced today that in the latest Evidence Street® update of 2.04.36 (Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer), individuals with early-stage, lymph node-negative invasive breast cancer who are considering adjuvant chemotherapy and receive gene expression profiling with MammaPrint®, “the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.”
Evidence Street® has determined that MammaPrint provides meaningful health benefits for women with breast cancer as concluded on December 3, 2018. The decision is posted on the Evidence Street® website, at https://app.evidencestreet.com , which is accessible to Blue Cross and Blue Shield (BCBS) companies and subscribing healthcare device, diagnostic and pharmaceutical manufacturers. Medical societies, health care associations and academic medical research centers may also subscribe to the service.
Although Evidence Street® does not make medical policy determinations, it is anticipated that this assessment will have a positive impact upon current medical policy discussions with health plans.
Dr. William Audeh, Chief Medical Officer at Agendia said:
“Evidence Street’s update on the net health outcomes of our MammaPrint 70-Gene Assay is an important milestone for Agendia and will have a significant impact on women with breast cancer in this network who need access to the most comprehensive genomic testing to help further tailor how their treatment is managed. MammaPrint is supported by the highest level of clinical evidence and is now recommended by multiple international guidelines for determining recurrence risk in breast cancer patients including patients with both lymph node-negative and lymph node-positive disease.
MammaPrint was included in the clinical practice guidelines of the National Comprehensive Cancer Network (NCCN®) in October 2018, the American Society for Clinical Oncology (ASCO), the St. Gallen International Breast Cancer Consensus Guidelines and the European Group on Tumor Markers (EGTM) in 2017, and also within the European Society for Medical Oncology (ESMO) guidelines. These recognitions and adoption will expand the reach of our genomic tests to more women with breast cancer.”
Bas van der Baan, Chief Clinical and Business Development Officer at Agendia said:
“We are pleased that payers continue to recognize the value of MammaPrint. This update presents an opportunity to further expand access to the test for patients with early stage breast cancer. We are working closely with healthcare plans to adopt MammaPrint in their medical policy in 2019 and contract for coverage of both lymph node-negative and node-positive patients.”
About Evidence Street®
Launched in 2015, Evidence Street® was created to make BCBSA’s evidence review process of medical technologies and therapies more transparent, efficient and comprehensive. BCBSA collects and analyzes available peer-reviewed evidence on devices, diagnostics and pharmaceuticals, then synthesizes that data and ascertains if the evidence is sufficient or insufficient to determine the effect on health outcomes.
MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph nodenegative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN®). The test is also recommended by many other national and international clinical practice guidelines.
Agendia is a privately held, leading precision oncology 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. The company’s offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology.
The MammaPrint BluePrint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world.
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. For more information on Agendia or the MammaPrint and BluePrint tests, visit agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.