QIAGEN N.V. announced the CE-marking and launch of its therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. Last year, the therascreen PIK3CA test was approved by the FDA and launched as a companion diagnostic test for Piqray (alpelisib) in the U.S.
The therascreen PIK3CA test is a new diagnostic assay for detection of activating mutations in the phosphatidylinositol3-kinase catalytic subunit alpha (PIK3CA) gene, and the first to enable testing of both DNA from FFPE tissue or plasma specimens. All QIAGEN therascreen PIK3CA tests leverage QIAGEN’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on detection of mutations in the PIK3CA gene.
One in eight women in Europe will develop breast cancer before the age of 85, making it the most common form of cancer in female patients. The therascreen assay detects 11 clinically actionable PIK3CA mutations, which are estimated to be present in approximately 40 percent of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+ HER2-) advanced breast cancer cases.
QIAGEN’s PIK3CA test was co-developed in collaboration with Novartis as a companion diagnostic for Piqray® in the United States. This real-time qualitative PCR test is performed using QIAGEN’s Rotor-Gene Q MDx instruments, which are members of the modular QIAsymphony family of automation solutions. The assay workflow also utilizes QIAGEN’s market leading QIAamp in-vitro diagnostic DNA sample preparation kits for FFPE tissue and plasma. Together with the PIK3CA test kit, the QIAamp DSP Circulating Nucleic Acid kit has now also been CE-marked and launched for use in liquid biopsy diagnostic procedures which analyze nucleic acid samples isolated from blood plasma specimens.
