FDA gives premarket approval to Therascreen PIK3CA Kit as companion diagnostic for breast cancer.

Qiagen announced the immediate launch of its Therascreen PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with Piqray (alpelisib), a newly approved therapy developed and marketed by Novartis.

The Therascreen PIK3CA Kit is the first companion diagnostic assay to obtain premarket approval from the FDA for use in any cancer indication for detection of activating mutations in the PIK3CA gene. It is also the first FDA approved assay for guiding treatment decisions in breast cancer using plasma specimens as a liquid biopsy. The assay detects 11 PIK3CA mutations, which are estimated to be present in approximately 40% of hormone receptor-positive (HR+) advanced or metastatic breast cancer patients. The real-time qualitative PCR kit is processed on Qiagen’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions. The test leverages Qiagen’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.