Qiagen is launching its therascreen® PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) as a companion diagnostic to help identify breast cancer patients eligible for treatment with Novartis’ Piqray (alpelisib), after both the drug and assay won FDA co-approval.
The companion diagnostic assay is the first to obtain FDA premarket approval for use in any cancer indication for detection of activating mutations in the PIK3CA gene—and the first FDA-approved assay for guiding treatment decisions in breast cancer using plasma specimens as a liquid biopsy, Qiagen said.
The therascreenPIK3CA Kit is designed to detect 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 uses Qiagen’s Rotor-Gene Q MDx, part of the company’s modular QIAsymphony family of automation solutions. The test also applies Qiagen’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.
Qiagen said the kit will be made available through leading labs in the U.S. through the company’s Day-One Lab Readiness program. A list of U.S. laboratories offering the new therascreen PIK3CA test is available here.
“We are convinced that our new therascreen PIK3CA Kit, which expands our market-leading therascreen portfolio of companion diagnostics, and the approval of Piqray together provide a valuable treatment option for those searching for new ways to combat advanced breast cancer,” Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area, said in a statement.
Qiagen’s therascreen PIK3CA Kit was co-developed with Novartis. The FDA on Friday approved Piqray in combination with the agency-approved endocrine therapy Faslodex® (fulvestrant); the combination is indicated 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.
Faslodex is approved for use both as monotherapy or in combination with Novartis’ Kisqali® (ribociclib), to treat advanced or metastatic breast cancer in postmenopausal women as their first endocrine-based therapy or with disease progression following endocrine therapy. Faslodex is also approved in separate combinations with Pfizer’s Ibrance® (palbociclib) and Eli Lilly’s Verzenio™ (abemaciclib) to treat advanced or metastatic breast cancer in women with disease progression after endocrine therapy.
The therascreen PIK3CA Kit co-approval with Piqray marks the seventh FDA approval of a therapy with a Qiagen companion diagnostic assay.
