QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanc...
December 06 2018 - 11:00AM
Business Wire
Fast-tracking clinical readiness of test to
support identification of patients eligible for novel Novartis PI3K
inhibitor BYL719 (alpelisib)
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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version on businesswire.com: https://www.businesswire.com/news/home/20181206005603/en/
QIAGENInvestor RelationsJohn Gilardi+49 2103 29
11711Sarah Fakih+49 2103 29 11457e-mail: ir@QIAGEN.com
Public RelationsThomas Theuringer+49 2103 29 11826Robert
Reitzee-mail: pr@QIAGEN.com+49 2103 29 11676
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