Qiagen receives US approval for cancer diagnostic product

Qiagen's therascreen EGFR RGQ PCR Kit has received US regulatory clearance to be used as a companion diagnostic in conjunction with a new lung cancer therapy from Boehringer Ingelheim.

The US Food and Drug Administration has ratified the product for use in guiding treatment with Gilotrif, a product that has been optimised for use among non-small cell lung cancer sufferers whose tumours have certain EGFR gene mutations. 

Qiagen's test will make it easier to identify patients who would be most likely to benefit from treatment with Gilotrif, with the approval marking the latest milestone in the expansion of the company's personalised healthcare franchise.

Peer Schatz, chief executive officer of Qiagen, said: "Qiagen's companion diagnostics are transforming patient care and extending lives around the world by providing personalised genomic information to guide treatment decisions."

This comes after the firm acquired rights to biomarkers from Columbia University and the BC Cancer Agency to develop new companion diagnostic products in future.