FDA approves Qiagen new companion diagnostic assay

8 July 2012 (Last Updated July 8th, 2012 18:30)

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

The US Food and Drug Administration (FDA) has approved Qiagen's new molecular companion diagnostic product, the 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 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.

Depending on the assay, which is critical to ensure reliable and consistent data for treatment decisions, the therascreen KRAS kit has been shown to have higher sensitivity for KRAS mutations between 0.8% and 6.4%.

Through determination of colorectal cancer patient's KRAS status and by avoiding unnecessary use of medicines, the US healthcare system could save more than $600m a year, according to the company.

Sample and assay technologies provider, Qiagen, said that approximately 60% of patients with mutation-negative KRAS genes may benefit from anti-EGFR therapy, whilst 40% whose tumours have KRAS mutations might not benefit.

Qiagen CEO, Peer M Schatz, said the approval of new molecular companion diagnostic product in the US marks an important step in personalised 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 importantly, making a positive impact on the care of patients," Schatz added.