Regulatory registration of Qiagen lung cancer companion diagnostic

Qiagen has announced the CE-IVD marking of its liquid biopsy-based companion diagnostic that analyses circulating nucleic acids obtained from blood samples to assess a genomic mutation in patients with non-small cell lung cancer (NSCLC).

The registration applies to more than 30 European countries and is said to make the company’s therascreen EGFR RGQ Plasma PCR kit the first-ever regulated companion diagnostic assay that has demonstrated clinical utility for guiding treatment decisions in patients with solid tumours based on the analysis of molecular biomarkers obtained from a body fluid.

The therascreen EGFR RGQ Plasma PCR kit, co-developed by Qiagen and AstraZeneca, helps physicians identify those advanced NSCLC patients who could benefit from treatment with the drug IRESSA (gefitinib) when a suitable tumour sample is not available. IRESSA, an oral monotherapy anticancer treatment from AstraZeneca, is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival.

“We use companion diagnostics to target medicines such as IRESSA to patients most likely to benefit,” explained Ruth March, VP personalised healthcare and biomarkers at AstraZeneca.

The test uses Qiagen’s QIAamp Circulating Nucleic Acid Kit for DNA purification, while analysis is based on an adapted version of Qiagen’s therascreen EGFR RGQ PCR kit (therascreen EGFR test). It is performed on Qiagen’s Rotor-Gene Q PCR detection platform.

“This innovative test … is the first to receive regulatory approval to assess EGFR mutation status from blood samples,” said March. “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.”

Qiagen CEO Peer M Schatz added, “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.”

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