Agendia Supports Genentech's Citizen's Petition Urging FDA To Hold In-Vitro Diagnostic Tests To One Set Of Scientific And Regulatory Standards

Main Category: Fertility
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 01 Jun 2009 - 5:00 PDT

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Agendia, a world leader in molecular cancer diagnostics, 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.

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 believes this has led to a precarious situation that raises patient safety and treatment decision concerns and creates an uneven playing field for providers of molecular diagnostic services.

Genentech's Citizen's Petition to the FDA is an important step in the movement towards in vitro diagnostic regulatory standardization. Agendia commends Genentech for making clinical validation, regulation and patient safety a top priority and looks forward to remaining engaged with key decision makers on this important healthcare issue.

Source
Agendia B.V.

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