QIAGEN completes second U.S. submission of companion diagnostic

QIAGEN ($QGEN) has completed its second U.S. submission for the therascreen KRAS RGQ PCR kit as a companion diagnostic for Erbitux (cetuximab), which is used by metastatic colorectal cancer patients.

The therascreen assay detects mutations of the KRAS gene, which are frequently found in human cancers. The assay allows physicians to determine those patients who are likely to respond to treatment, thus avoiding higher costs and harmful patient side effects. About 60% of all colorectal cancer patients have a non-mutated KRAS gene, while about 40% show mutations that make their cancers unresponsive to this class of drugs.

The first submission of the KRAS assay in July paired QIAGEN's molecular test with another drug for treatment of metastatic colorectal cancer. Both therapies are monoclonal antibody EGFR inhibitors expected to target a range of cancers.

"QIAGEN's Personalized Healthcare franchise achieved a double milestone with these two separate U.S. submissions. These innovations show important progress in our strategy to accelerate QIAGEN's growth in 2012 and beyond. We are planning to validate the KRAS assay on our QIAsymphony RGQ platform, and we expect approvals of both PMAs in 2012," said CEO Peer Schatz in a statement.

Erbitux, which had sales last year of $820 million, is marketed in the U.S. by Bristol-Myers Squibb and Eli Lilly. Merck KGaA has the right to market Erbitux outside the U.S. and Canada.

- check out QIAGEN's statement