FDA approves colorectal cancer diagnostic test

VALENCIA, CA – The U.S. Food and Drug Administration (FDA) has approved Qiiagen’s new molecular companion diagnostic product, therascreen KRAS RGQ PCR test kit, to guide on the use of Erbitux for approximately 110,000 US patients with colorectal cancer.

The therascreen KRAS test uses an automated Rotor-Gene Q MDx molecular detection real-time PCR technology to determine optimal treatment for colorectal cancer patients who are candidates for epidermal growth factor receptor (EGFR)-inhibitor therapy.

The test kit has been shown to have higher sensitivity for KRAS mutations between 0.8% and 6.4%, depending on the assay which is critical to ensure reliability and consistency of data used for treatment decisions.

According to Qiagen, the US healthcare system can save more than $600 million per year by determining colorectal cancer patients’ KRAS status and by avoiding unnecessary use of medicines.