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Qiagen Receives CE Mark for Therascreen EGFR Liquid Biopsy Test

NEW YORK(GenomeWeb) – Qiagen today announced that it has received a CE-IVD mark for its therascreen EGFR RGQ Plasma PCR kit, a liquid biopsy companion diagnostic to guide treatment for patients with non-small cell lung cancer.

The test, co-developed by Qiagen and AstraZeneca, is intended to help physicians identify which advanced NSCLC patients are more likely to benefit from treatment with AstraZeneca's EGFR inhibitor Iressa (gefitinib) in cases where when a suitable tumor tissue sample is not available.  

The assay uses Qiagen's QIAamp circulating nucleic acid kit for DNA purification, and is adapted from Qiagen's therascreen EGFR RGQ PCR kit, which the company has already validated and commercialized for use with formalin-fixed, paraffin-embedded solid tumor samples. The assay runs on Qiagen's Rotor-Gene Q PCR platform.

Qiagen noted in a statement that CE marking of the new blood-based assay comes as the European Medicines Agency has extended Iressa's drug label to include the detection of EGFR mutations in circulating tumor DNA in cases without an available tumor sample.

The label change was supported by the IFUM, or IRESSA Follow-Up Measure, study, which assessed patients' mutation status in tumor and circulating tumor DNA in parallel.

Qiagen also recently filed a US regulatory submission for an FFPE-based EGFR test as a proposed companion diagnostic to Iressa.

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