Agendia Receives U.S. FDA Clearance for MammaPrint Breast Cancer Diagnostic Test
Posted on: Tuesday, 6 February 2007, 12:01 CST
AMSTERDAM, The Netherlands, Feb. 6 /PRNewswire/ -- Agendia announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's MammaPrint(C) breast cancer diagnostic test. MammaPrint(R) is a gene expression profiling service to assess the risk of recurrence in breast cancer patients. MammaPrint(R) represents a U.S. regulatory milestone as the first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire market clearance from the FDA, and is the agency's first step toward standardizing these multi-gene expression tests.
"Today's FDA clearance of MammaPrint(R) is a milestone for patient care and safety," said Dr. Bernhard Sixt, Chief Executive Officer at Agendia. "As the first test of its kind cleared by the FDA, this type of regulatory review benefits breast cancer patients and provides regulatory clarity to the medical community. At present, MammaPrint(R) is the first cleared IVDMIA which can be marketed in the US in compliance with these new FDA guidelines. We are exploring ways to make this product available in the US."
"We are pleased about today's FDA announcement as it signifies an important first step in standardizing IVDMIAs to ensure a safe and welcomed advancement in cancer diagnostics," said Diane Blum, MSW, Executive Director of CancerCare.
This week, the FDA will hold a public hearing to discuss draft guidance developed by the agency regarding IVDMIAs. The FDA intends to regulate multi- gene molecular diagnostics tests that meet specific criteria to ensure maximum safety and efficacy, as well as to ensure IVDMIA results can be easily interpreted by physicians.
About Agendia BV
Agendia, located in Amsterdam, the Netherlands, is a world leader in gene expression analysis-based diagnostics with three products on the market. The company focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling. Agendia maintains close ties with several leading European academic centers to develop state of the art diagnostic tests for cancer. Agendia also offers its expertise to pharmaceutical companies focusing on development of highly effective personalized drugs in the area of oncology.
More information about Agendia BV and MammaPrint is available at http://www.agendia.com/
Agendia BV
CONTACT: U.S. Media - David Bashaw, Ogilvy Public Relations Worldwide+1-212-880-5352, david.bashaw@ogilvypr.com; EU and non-US Media Contact - FinnStahlschmidt, GCI Mannov Public Relations+45-24-62-31-58, fs@mannov.dk
Web site: http://www.agendia.com/
Source: PRNewswire
Related Articles
- FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C
- Should Minors Be Tested For The Breast Cancer Gene?
- XDx Wins FDA Clearance for New Gene Expression Test
- XDx's AlloMap(R) Gene Expression Test Cleared By U.S. Food and Drug Administration (FDA)
- DiaGenic to Partner With Opaldia in UK on Blood Based Breast Cancer Gene Expression Test
- Couples to Test Embryos for Cancer Gene
- Gene Expression Test From XDx Now Indicated for Earlier Use and Prediction of Acute Cellular Rejection
- Film Shows Lives Changed: Director Chronicles How Testing Positive for Cancer Gene Affects Women
- Embryo Screening for Breast Cancer Genes Catholic Church Says Research Proposals Are 'a Step Too Far'
- Article Supports Use of Diagnostic Blood Tests for Allergies; Evidence Helps Boost Low Accuracy of Diagnosis Rates and Improve Patient Care
 |
 |
User Comments (0)
RSS Feeds