HUNTINGTON BEACH, California and AMSTERDAM, December 1 Agendia, a world leader in molecular cancer diagnostics, announced today thatPalmetto GBA, California's Part B Medicare administrator, has establishedcoding guidelines for the company's MammaPrint test. MammaPrint is Agendia'sFDA-cleared breast cancer recurrence test, which has been reimbursed bypayors since 2008.
Patients across the United States can now submit claims for theMammaPrint test directly to Palmetto GBA in California where the test resultsare analyzed. The coding guidelines for healthcare providers are available atthe Centers for Medicare and Medicaid Services (CMS) website athttp://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=30376&lcd_version=5&show=all.
"Palmetto's decision to include MammaPrint in their reimbursementguidelines will provide greater access to this test for more women and theirdoctors when faced with difficult treatment decisions around breast cancer,"said Dr. Richard Bender, Chief Medical Officer of Agendia.
MammaPrint is the first and only breast cancer recurrence test cleared bythe U.S. Food and Drug Administration (FDA). FDA clearance under the in vitrodiagnostic multivariate index assay (IVDMIA) guidelines requires clinical andanalytical validation and reporting systems to ensure that patient safety andefficacy are addressed. Highly accurate, MammaPrint identifies patients withearly metastasis-patients who are likely to develop metastases within fiveyears following surgery. Several authoritative studies have shown thatchemotherapy particularly reduces early metastasis risk. In planningtreatment, the MammaPrint test results, in addition to other clinicalinformation and pathology tests, provide doctors with a clear rationale toevaluate the benefits of chemotherapy
All MammaPrint tests are conducted in Agendia's CLIA-accredited servicelaboratory. Breast cancer recurrence assays currently marketed by othermanufacturers have not been subject to the rigorous FDA clearance process.
Agendia is at the forefront of the personalized medicine revolution,striving to bring more effective, individualized treatments within reach ofpatients. Building on a cutting-edge genomics platform for tumor geneexpression profiling, the company's tests help physicians more accuratelytailor cancer treatments. Agendia markets four products, with several newgenomic tests under development. In addition, Agendia collaborates withpharmaceutical companies to develop highly effective personalized drugs inthe area of oncology. The Company was awarded the 2008 North AmericanOncology Clinical Diagnostics Healthcare Innovation Award by Frost &Sullivan. Agendia is based in Huntington Beach, California, and in Amsterdam,The Netherlands.MEDIA CONTACTS: Hans Herklots Valerie Delva Head of Corporate Communications Account Executive Agendia Ricochet Public Relations +31-20-462-1557 Office +1-212-679-3300 x131 Office +31-620-083-509 Mobile [email protected] [email protected]
SOURCE Agendia B.V.