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Agendia Supports Genentech's Citizen's Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards
Date:5/28/2009

HUNTINGTON BEACH, California, and AMSTERDAM, May 28 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech's Citizen's Petition. Filed on December 5, 2008, Docket No. FDA-2008-P-0638-0001/CP petitions that all in vitro diagnostic tests be held to one set of scientific and regulatory standards. In response, on May 28, 2009, Agendia formally submitted a letter of support to the U.S. Food and Drug Administration (FDA). The Genentech petition and other documents submitted in support of and in opposition to the petition can be accessed here: http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA- 2008-P-0638

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Agendia's leading product, MammaPrint(R), is commercialized globally to aid physicians in making informed treatment decisions for breast cancer patients. In 2007, MammaPrint became the first in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. FDA clearance requires clinical and analytical validation and reporting systems that ensure patient safety issues are addressed. Manufacturers of breast cancer recurrence assays that are not FDA-cleared operate solely under CLIA regulations and are free to make claims of superiority, safety or otherwise, regardless of scientific and clinical evidence. Consequently, physicians do not have the scientific and clinical data to evaluate some of the most promising advances in molecular diagnostics. The FDA deemed the need for regulation of the utmost importance and introduced the IVDMIA guidelines in 2006. Formal regulatory decisions on the matter have since been stagnant, however. Agendia
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SOURCE Agendia B.V.
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