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Qiagen new molecular companion diagnostic test wins FDA nod

Qiagen has won the US Food and Drug Administration (FDA) approval for its new molecular companion diagnostic product, therascreen KRAS RGQ PCR test kit, to provide guidance on the use of Erbitux for approximately 110,000 US patients with colorectal cancer.

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

The therascreen KRAS 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 reliable and consistent data for treatment decisions.

The company said the US healthcare system could save more than $600m per year through determination of colorectal cancer patient’s KRAS status and by avoiding unnecessary use of medicines.

Qiagen chief executive officer Peer M. Schatz said the approval of new molecular companion diagnostic product in the US marks an important step in personalized healthcare for the company.

"With a growing portfolio of innovative tests and efficient automation platforms, we are proud to be helping to make healthcare more effective, providing ways for payers to more efficiently use healthcare resources and, most important, making a positive impact on the care of patients," Schatz added.