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FDA Clears Qiagen KRAS Test as CDx for Erbitux

NEW YORK (GenomeWeb News) – Qiagen announced after the close of the market on Friday that the US Food and Drug Administration has cleared for marketing its therascreen KRAS RGQ PCR Kit to be sold as a companion diagnostic test for Erbitux (cetuximab), a drug used for treating colorectal cancer.

Erbitux is an EGFR inhibitor marketed in the US by Bristol-Myers Squibb along with Eli Lily and its Imclone Systems unit. 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. Qiagen estimated the current US market for the test to be about $20 million.

The company submitted the test for premarket approval with FDA in August. Qiagen also had filed a PMA as a rolling submission with FDA for the therascreen test in combination with Amgen's Vectibix (panitumumab) and has said that it expects approval as a companion diagnostic for that drug sometime this year.

The therascreen KRAS test is the first therascreen test to receive FDA approval. Qiagen markets therascreen assays in Europe for biomarkers including KRAS, EGFR, NRAS, BRAF, P13K, JAK2, MGMT, and UGT1A1. The therascreen KRAS and EGFR kits were approved in Japan in 2011.

The therascreen KRAS test runs on the Rotor-Gene Q MDx, Qiagen's automated molecular detection instrument that uses real-time PCR technology. The test is the second assay cleared by FDA for use on the Rotor-Gene Q MDx. The company's artus Infl A/B RG RT-PCR for detecting Influenza A and B received 510(k) clearance in April.