Medicare Administrator Establishes Reimbursement Coding Policy for Agendia's Breast Cancer Recurrence Test MammaPrint(R)
By Agendia B.v., PRNEMonday, November 30, 2009
HUNTINGTON BEACH, California and AMSTERDAM, December 1 - Agendia, a world leader in molecular cancer diagnostics, announced today
that Palmetto GBA, California's Part B Medicare administrator, has
established coding guidelines for the company's MammaPrint test. MammaPrint
is Agendia's FDA-cleared breast cancer recurrence test, which has been
reimbursed by payors since 2008.
Patients across the United States can now submit claims for the
MammaPrint test directly to Palmetto GBA in California where the test results
are analyzed. The coding guidelines for healthcare providers are available at
the Centers for Medicare and Medicaid Services (CMS) website at
www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=30376&lcd_version=5&show=all.
"Palmetto's decision to include MammaPrint in their reimbursement
guidelines will provide greater access to this test for more women and their
doctors when faced with difficult treatment decisions around breast cancer,"
said Dr. Richard Bender, Chief Medical Officer of Agendia.
About MammaPrint(R)
MammaPrint is the first and only breast cancer recurrence test cleared by
the U.S. Food and Drug Administration (FDA). FDA clearance under the in vitro
diagnostic multivariate index assay (IVDMIA) guidelines requires clinical and
analytical validation and reporting systems to ensure that patient safety and
efficacy are addressed. Highly accurate, MammaPrint identifies patients with
early metastasis-patients who are likely to develop metastases within five
years following surgery. Several authoritative studies have shown that
chemotherapy particularly reduces early metastasis risk. In planning
treatment, the MammaPrint test results, in addition to other clinical
information and pathology tests, provide doctors with a clear rationale to
evaluate the benefits of chemotherapy
All MammaPrint tests are conducted in Agendia's CLIA-accredited service
laboratory. Breast cancer recurrence assays currently marketed by other
manufacturers have not been subject to the rigorous FDA clearance process.
About Agendia
Agendia is at the forefront of the personalized medicine revolution,
striving to bring more effective, individualized treatments within reach of
patients. Building on a cutting-edge genomics platform for tumor gene
expression profiling, the company's tests help physicians more accurately
tailor cancer treatments. Agendia markets four products, with several new
genomic tests under development. In addition, Agendia collaborates with
pharmaceutical companies to develop highly effective personalized drugs in
the area of oncology. The Company was awarded the 2008 North American
Oncology 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 vdelva@ricochetpr.com hans.herklots@agendia.com
MEDIA CONTACTS: Hans Herklots, Head of Corporate Communications, Agendia, +31-20-462-1557 Office, +31-620-083-509 Mobile, hans.herklots at agendia.com; Valerie Delva, Account Executive, Ricochet Public Relations, +1-212-679-3300 x131 Office, vdelva at ricochetpr.com
Tags: Agendia B.V., california, california and amsterdam, Huntington beach, Netherlands