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NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Qiagen's Therascreen PIK3CA RGQ PCR Kit as a companion diagnostic for identifying which advanced breast cancer patients have PIK3CA mutations and are likely to respond to Novartis' Piqray (alpelisib).

The test is designed to analyze PIK3CA mutations in tissue and blood samples. Patients who are mutation negative by liquid biopsy analysis should undergo tumor biopsy for tissue analysis.

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