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Qiagen Submits Second PMA for Therascreen KRAS Companion Dx

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Qiagen today said that it has submitted a second Premarket Approval application to the US Food and Drug Administration for its therascreen KRAS RGQ PCR Kit for use a companion diagnostic with metastatic colorectal cancer drug Erbitux (cetuximab).

Erbitux is sold in the US by Bristol-Myers Squibb and Eli Lilly. Outside of the US and Canada, it is sold by Germany's Merck KGaA.

The therascreen KRAS assay detects mutations in the KRAS gene and is designed to help physicians predict which patients are likely to respond to monoclonal antibody EGFR inhibitors, a class of drugs that includes Erbitux. Qiagens said that about 40 percent of colorectal cancer patients show mutations that make their cancers unresponsive to that class of drugs.

Qiagen also had filed a PMA as a rolling submission with FDA for the therascreen test in combination with Amgen's Vectibix (panitumumab). The firm completed that submission last month.

"We are planning to validate the KRAS assay on our QIAsymphony RGQ platform, and we expect approvals of both PMAs in 2012," Qiagen CEO Peer Schatz said in a statement. "Experts have estimated that using KRAS testing in colorectal cancer patients could save healthcare systems more than $600 million in drug costs alone."

Sales of Erbitux were around $820 million last year, Qiagen noted. Sales of Vecitibix were $288 million in 2010.