New companion diagnostic for PIK3CA biomarkers enhances precision medicine in breast cancer

QIAGEN has 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 therascreenPIK3CA Kit is the first companion diagnostic assay to obtain premarket approval from the  Food and Drug Administration (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 percent 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.

“Each year, an estimated 66,500 patients in the United States are diagnosed with advanced or metastatic breast cancer. We are making the therascreen PIK3CA Kit available immediately following this FDA approval through leading laboratories in the U.S. as a result of QIAGEN’s Day-One Lab Readiness program for Precision Medicine,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area in the announcement.

QIAGEN’s therascreen PIK3CA Kit was co-developed in collaboration with Novartis and co-approved with PIQRAY (alpelisib) by the FDA. The Novartis drug is indicated in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.