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