Qiagen brings PIK3CA breast cancer kit to Europe

2019 12 12 00 55 0189 Breast Cancer3 400

Qiagen has announced the European launch of its therascreen polymerase chain reaction (PCR) kit for detecting PIK3CA mutations in patients with late-stage breast cancer, following receipt of the CE Mark.

The PIK3CA Rotor-Gene Q (RGQ) PCR kit is a diagnostic assay capable of detecting 11 mutations in the PIK3CA gene that are present in approximately 40% of advanced breast cancer cases, the company said in a statement. Clinicians can use the PCR kit to analyze DNA obtained from both formalin-fixed, paraffin-embedded (FFPE) tissue and plasma specimens.

Qiagen launched its therascreen PIK3CA test in the U.S. last year as a companion diagnostic with alpelisib (Piqray, Novartis) after receiving clearance from the U.S. Food and Drug Administration.

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