FFPE and Liquid Biopsy PIK3CA diagnostics to enhance precision medicine in advanced breast cancer

QIAGEN N.V. has 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. In 2019, the therascreen PIK3CA test was approved by the FDA and launched as a companion diagnostic test for Piqray^® in the US.

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.

1 in 8 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% of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+ HER2-) advanced breast cancer cases.

“This launch in Europe further underscores our commitment to support patients with breast cancer, the most common cancer in female cancer patients, with an estimated incidence of 562,500 in Europe in 2018 according to the WHO” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics. “We are convinced that our therascreen PIK3CA Kit, which expands our market-leading therascreen portfolio of companion diagnostics, will provide a valuable testing option for those seeking new ways to combat advanced breast cancer. We are committed to making the therascreen PIK3CA Kit available immediately so that leading laboratories in Europe can provide patients with the test as soon as possible.”

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.

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