Companion Diagnostic Guides Colorectal Cancer Treatment

A companion diagnostic kit guides treatment for metastatic colorectal cancer patients for whom surgery and chemotherapy are insufficient.

The therascreen KRAS RGQ polymerase chain reaction (PCR) kit (therascreen KRAS test) provides guidance on the use of Erbitux (cetuximab, EGFR) as a treatment in patients with metastatic colorectal cancer. This companion diagnostic assay is used to determine the presence of mutations in the human KRAS gene that assist in identifying colorectal cancer patients most likely to benefit from anti-EGFR therapies.


The US Food and Drug Administration (FDA; Silver Spring, MD, USA) approved the KRAS RGQ PCR Kit for use in the US. The manufacturer of the KRAS test kit, Qiagen (Hilden, Germany), already markets a broad range of companion diagnostic tests covering 30 biomarkers in Europe, Asia/Pacific and Japan.

In contrast to laboratory-developed tests (LDTs), the FDA-approved therascreen KRAS test gives healthcare providers a fast, consistent, and reliable process to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-inhibitor therapy.

The therascreen KRAS test offers laboratories an efficient workflow based on the Rotor-Gene Q MDx, an automated molecular detection instrument that uses real-time PCR technology. All other companion diagnostics in development, as well as a range of other molecular diagnostic tests, are being developed for US regulatory approval on the Rotor-Gene Q MDx.

The therascreen KRAS kit is the second assay cleared/approved by the FDA for use on the Rotor-Gene Q MDx. Earlier in 2012, Qiagen's artus Infl A/B RG RT-PCR for the detection of Influenza A/B was cleared for use on Rotor-Gene Q MDx, with the instrument also receiving FDA 510(k) clearance at the same time.

Related Links:
US Food and Drug Administration
Qiagen