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QIAGEN Completes Second U.S.Submission for Companion Diagnostic to Guide Treatment Decisions in Colorectal Cancer
Date:8/5/2011

the way medicine is practiced. Our leadership in enabling and accelerating this transformation will continue to be a dynamic growth driver for QIAGEN."

QIAGEN's PMA submissions follow the FDA's issuance of guidelines for the co-development and approval of drugs and associated companion diagnostics on July 14, 2011. The agency encourages the use of personalized medicines that rely on approved or cleared companion diagnostic devices. Without approval or clearance, the FDA sees tests as a potential public risk due to lack of adequate proof of accuracy and of well-controlled manufacturing processes. The guidelines recommend that in future drug labeling bears a reference to a type of FDA approved or cleared test so that only an approved or cleared companion diagnostic could be used to guide treatment decisions. QIAGEN is a pioneer in developing the PMA approach for the approval of companion diagnostics such as the KRAS assays.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical
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SOURCE QIAGEN N.V.
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