QIAGEN’s therascreen PIK3CA RGQ PCR Kit secures the approval for use in guiding treatment decisions for a newly approved therapy PIQRAY (alpelisib).

The kit was approved by the US Food and Drug Administration (FDA) 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 pre-market approval from the FDA for use in any cancer indication for detection of activating mutations in the gene.

QIAGEN molecular diagnostics business area head and senior vice president Thierry Bernard said: “We are very pleased to launch this innovative companion diagnostic in tandem with our partners at Novartis. This milestone further underscores our commitment to support patients with breast cancer. 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.

The Kit is also the first FDA approved assay for guiding treatment decisions using plasma specimens as a liquid biopsy.

QIAGEN said that 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.

According to the company, the real-time qualitative PCR kit is processed on its Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions.

The test leverages QIAGEN co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.

QIAGEN has partnered with Novartis to co-develop the therascreen PIK3CA Kit and the kit was co-approved with PIQRAY (alpelisib) by the FDA.

Bernard added: “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.”