FDA approved Qiagen’s therascreen® KRAS RGQ PCR Kit as a companion diagnostic for identifying patients with metastatic colorectal cancer (mCRC) who are most likely to respond to Erbitux® (cetuximab) therapy. The approval was made in parallel with clearance of Bristol-Myers Squibb and Lilly’s Erbitux in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) chemotherapy as first-line treatment of patients with KRAS mutation-negative epidermal growth factor receptor (EGFR)-expressing mCRC.

Expanded approval of Erbitux as part of combination therapy for EGFR-expressing wild-type KRAS mCRC is conditional on pairing the treatment with an FDA-approved companion diagnostic, and the therascreen KRAS test is actually the only suitable assay to have been sanctioned by the U.S. regulator, Qiagen says. The firm projects the U.S. market for the test is currently in the region of $20 million for this indication alone.

The therascreen KRAS test is the first of Qiagen’s companion diagnostics to achieve approval in the U.S. The firm already has 10 real-time PCR or pyrosequencing-based assays approved in Europe, where it markets therascreen tests for KRAS, EGFR, NRAS, BRAF, P13K, JAK2, MGMT, and UGT1A1. In Japan the therascreen KRAS and EGFR kits were approved in 2011. therascreen KRAS is the second assay to be approved by FDA for use on the Rotor-Gene Q MDx platform. U.S. approval of both the Rotor-Gene instrument and the artus Infl A/B RG RT-PCR test for influenza A and B was achieved earlier this year.

Qiagen says it has more than 15 projects in progress to codevelop and market companion diagnostics with firms including Amgen, AstraZeneca, Boehringer Ingelheim, and Pfizer. The deal with Pfizer, signed just over a year ago, is also focused on developing a KRAS companion diagnostic to identify patients with wild-type KRAS who are most likely to respond to Pfizer’s EGFR inhibitor dacomitinib.

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