Huntington Beach, California, and Amsterdam (ots/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?m
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.
For more information, please visit http://www.agendia.com
ots Originaltext: Agendia B.V.
Im Internet recherchierbar: http://www.presseportal.ch
MEDIA CONTACTS: Hans Herklots, Head of Corporate Communications,
Agendia, +31-20-462-1557 Office, +31-620-083-509 Mobile,
; Valerie Delva, Account Executive, Ricochet
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