Qiagen therascreen KRAS RGQ PCR kit

Qiagen has received FDA approval to market the therascreen KRAS RGQ PCR kit to provide guidance on the use of Erbitux (cetuximab) as a treatment in patients with metastatic colorectal cancer. The company currently markets the kit in Europe and Japan.

The product provides an FDA-approved diagnostic available for making treatment decisions for colorectal cancer patients. Approximately 110,000 colorectal cancer patients each year in the US could benefit from KRAS testing, according to the company’s estimates. Studies show the US healthcare system could save more than $600 million annually by avoiding unnecessary use of medicines in colorectal cancer patients through determinations of their KRAS status.

The first FDA approval of the test pairs this companion diagnostic with Erbitux, an EGFR inhibitor. KRAS status evaluation using an FDA-approved diagnostic test is used to determine treatment, and the product is said to be the only test with this status.

In contrast to laboratory-developed tests, the product 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 kit is said to have higher sensitivity (ie, a lower limit of detection, LOD) for KRAS mutations between 0.8 and 6.4% depending on the assay, which is critical to ensuring reliable and consistent data for treatment decisions.