The CE-IVD marking of a new liquid biopsy-based companion diagnostic, that has demonstrated clinical utility for guiding treatment decisions in patients with solid tumours, has been announced. The first assay of its kind to be registered, the diagnostic is based upon the analysis of molecular biomarkers obtained from body fluid.
Co-developed by QIAGEN and AstraZeneca, the new therascreen EGFR RGQ Plasma PCR kit has been registered in more than 30 European countries and is being launched this month.
Circulating nucleic acids obtained from blood samples are analysed to asses a genomic mutation in patients with non-small cell lung cancer (NSCLC), the most common form of this cancer. The kit helps physicians to identify those advanced NSCLC patients who could benefit from treatment with the drug IRESSA when a suitable tumour sample is not available.
Peer M. Schatz, CEO of QIAGEN, said: "Through this collaboration and other partnerships, QIAGEN is building an extensive portfolio of liquid biopsy solutions for personalised healthcare, creating highly reliable genomic tests and automated workflows based on samples of blood or other body fluids to help make treatment decisions and monitor treatment response and disease progress."
Ruth March, VP personalised healthcare and biomarkers at AstraZeneca, said: "Testing circulating tumour DNA gives physicians the option to prescribe IRESSA to patients when solid tumour tissue is unavailable and a surgical biopsy is impractical. This technology has the potential to transform treatment for these cancer patients."