On December 6, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (Press release, Qiagen, DEC 6, 2018, View Source [SID1234531932]).

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The Novartis drug candidate is in late-stage development, and QIAGEN expects to provide its companion diagnostic to clinical laboratory partners who will then be ready to offer immediate access to the test upon potential regulatory approvals of BYL719 and QIAGEN’s test.

Novartis has completed a Phase III clinical trial (SOLAR), testing BYL719 in combination with fulvestrant for patients with PIK3CA mutated HR+/HER2- advanced breast cancer.

QIAGEN’s companion diagnostic for PIK3CA mutations will provide a complete Sample to Insight workflow, from DNA extraction to detection of the clinically relevant mutations and final reporting. The test will be clinically validated for analysis of both FFPE tissue and liquid biopsy samples using plasma. The companion diagnostic will run on the Rotor-Gene Q MDx cycler, which is part of the modular QIAsymphony family of automation solutions, established in numerous pathology laboratories worldwide.