Qiagen’s new liquid biopsy-based companion diagnostic receives CE Mark

Qiagen has been granted European CE Mark approval for a new groundbreaking new liquid biopsy-based companion diagnostic product.

The Therascreen EGFR RGQ Plasma PCR kit was developed in partnership with AstraZeneca and is designed for the analysis of circulating nucleic acids obtained from blood samples to assess an important genomic mutation in patients with non-small cell lung cancer.

It is the first ever regulated companion diagnostic assay to demonstrate clinical utility in guiding treatment decisions in patients with solid tumours based on the analysis of molecular biomarkers obtained from a body fluid.

The kit is being launched this month and will help to determine whether patients could benefit from treatment with AstraZeneca's oral monotherapy anti-cancer treatment Iressa.

Peer Schatz, chief executive officer of Qiagen, said: "Our collaboration with AstraZeneca has achieved an important milestone with the European regulatory registration of this new technology to help in guiding the treatment of lung cancer patients."

Earlier this month, the company announced the acquisition of the enzyme solutions business of Enzymatics, a leading provider of enzymes for use in next-generation sequencing applications.