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Qiagen CE marks lung cancer liquid biopsy

This article was originally published in Clinica

Executive Summary

The liquid biopsy space is continuing to pick up speed, with Qiagen CE marking a companion diagnostic that analyzes circulating tumor DNA (ctDNA) in blood. The test, the therascreen EGFR RGQ Plasma PCR kit, is used in patients with non-small cell lung cancer (NSCLC) to identify which of them could benefit from treatment with AstraZeneca’s Iressa (gefitinib), when tumor tissue is not available or evaluable. Qiagen claims it is the first regulated test of its kind. The diagnostic was co-developed by Qiagen and AstraZeneca, following a deal between the two companies signed in July, and also comes after the European Medicines Agency updated Iressa’s label in September to allow ctDNA testing when a tumor sample is not available. AstraZeneca estimates that up to 25% of NSCLC patients do not have an available or evaluable tumor sample. Qiagen plans to launch the kit this month. The Dutch firm already offers therascreen EGFR test as a tissue-based companion diagnostic for lung cancer, which is also approved in the US and China.

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