QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanced breast cancer

GERMANTOWN, Maryland HILDEN, Germany–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
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.

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.

Please find the full press release here

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