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Dx Focus: Clarient to Offer Qiagen Therascreen KRAS Test as Erbitux CDx

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Qiagen said this week that GE Healthcare subsidiary Clarient will offer Qiagen's Therascreen KRAS RGQ PCR kit as a companion diagnostic to guide the use of Erbitux (cetuximab) as a treatment in patients with metastatic colorectal cancer.

Clarient is a US-based oncology service lab that has a customer base of more than 2,000 pathologists, oncologists, clinical laboratories and hospitals. Qiagen said that Clarient chose the KRAS RGQ PCR kit following the kit's approval by the US Food and Drug Administration in July.

The US Food and Drug Administration last year approved a new indication for Bristol-Myers Squibb/Eli Lilly's Erbitux in combination with a chemotherapy regimen as a first-line treatment in patients with metastatic colorectal cancer who have EGFR-expressing, KRAS wild-type tumors. Simultaneously, the agency approved Qiagen's KRAS test to pick out best responders to the drug.

Qiagen's KRAS test runs on the Rotor-Gene Q MDx real-time PCR instrument, which received FDA approval in April 2012 along with a diagnostic test for influenza A/B (PCR Insider, 4/19/2012).

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