AGENDIA - FDA Broadens Clearance for MammaPrint - Gilde Healthcare

AGENDIA – FDA Broadens Clearance for MammaPrint

17. Dezember 2009

HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS – Agendia, a world leader in molecular cancer diagnostics, announced today that the US Food and Drug Administration (FDA) cleared its MammaPrint breast cancer recurrence test for all ages. MammaPrint is the only FDA-cleared breast cancer recurrence test available to patients and physicians. Over the past three years, the FDA has issued four clearances for MammaPrint, covering all aspects of this important service.

“This FDA clearance, along with our recently obtained CMS coverage for all stage I and II breast cancer patients, including patients with up to three positive lymph nodes, will facilitate our discussions with healthcare providers about patients’ eligibility criteria for MammaPrint,”

said Dr. Bernhard Sixt, Agendia’s Chief Executive Officer.

“This new clearance confirms the opinion of the international medical community that MammaPrint carries clinical utility and is safe and effective in breast cancer patients of all ages,”

said Dr. Richard Bender, Chief Medical Officer of Agendia.

“Seeking clearance for all ages further demonstrates Agendia’s commitment to provide patients and physicians with high quality FDA-cleared tests to help guide vital treatment decisions.”

In Europe, MammaPrint has been approved for all ages since 2004.

About MammaPrint

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 patient safety issues are addressed.  Highly accurate, MammaPrint identifies patients with early metastasis risk – 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 provide doctors with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests.

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. Agendia is based in Huntington Beach, California, and in Amsterdam, The Netherlands.

Media Contacts

Hans Herklots
Head of Corporate Communications
Agendia
+31.20.462.1557 Office
+31.620.083.509 Mobile
hans.herklots@agendia.com

Valerie Delva
Account Executive
Ricochet Public Relations
+1.212.679.3300 x131 Office
vdelva@ricochetpr.com

Gilde Healthcare Portfolio Company Big Health Raises $75 Million in Series C Funding

Big Health, a digital therapeutics company dedicated to helping millions back to good mental health, today announced that it has raised $75 million in a Series C funding round, led by new investor SoftBank Vision...
19. Januar 2022

ProVerum raises €30M in Series A funding led by Gilde Healthcare & Lightstone Ventures

ProVerum Limited, an Irish medical device company developing a minimally invasive solution to treat benign prostatic hyperplasia (BPH) in the doctor’s office, today announced the closing of a €30 million Series A equity financing led...
11. Januar 2022

Gilde Healthcare portfolio Volta Medical treats first U.S. patients with persistent cardiac arrythmias

Volta Medical, a pioneering health tech company developing artificial intelligence (AI)-based software solutions to treat cardiac arrythmias, today announced the introduction of its leading-edge product, VX1, at three leading U.S. hospitals. New York Presbyterian Queens,...
21. Dezember 2021