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Clarient to Offer Qiagen's Therascreen KRAS Assay as CDx for Erbitux

NEW YORK (GenomeWeb News) – Qiagen today said that GE company Clarient will offer its therascreen KRAS RGQ PCR kit as a companion diagnostic.

Clarient will offer the test to help guide the use of Erbitux (cetuximab) for treating patients with metastatic colorectal cancer. Clarient chose the therascreen KRAS assay and Qiagen's Rotor-Gene Q molecular diagnostic platform after the US Food and Drug Administration approved the test in July, Qiagen said.

Clarient provides cancer laboratory testing services in the US.

The therascreen KRAS assay detects KRAS gene mutations and is used to help physicians predict which patients will likely respond to EGFR inhibitors, a class of drugs that includes Erbitux. Qiagen, which last night announced that its fourth-quarter revenues rose 4 percent, said that studies indicate that the US healthcare system could save more than $600 million annually by determining KRAS status in colorectal cancer patients and eliminating the unnecessary use of medicines.

Erbitux is 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.

"We believe precision medicine is the new direction in diagnosing and treating cancer and Clarient uses state-of-the-art diagnostic technologies like the therascreen KRAS test to bring clarity and precision to physicians to assist them in making better treatment decisions for their patients," Carrie Eglinton Manner, CEO of Clarient, said in a statement. "Clarient’s comprehensive offering and fast turnaround time coupled with our experience with the therascreen KRAS test permits us to provide a higher level of performance."