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QIAGEN Partners to Develop Novel Companion Diagnostic in Lung Cancer

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced a partnership with Mirati Therapeutics, Inc. (NASDAQ: MRTX) to co-develop and commercialize a companion diagnostic test to guide the use of Mirati’s glesatinib (MGCD265), a targeted therapy under development for non-small cell lung cancer (NSCLC). The companies aim to create a regulator-approved test to personalize treatment decisions in NSCLC by detecting RNA biomarkers produced by exon 14 skipping mutations of the MET gene.

QIAGEN companion diagnostic wins FDA approval for use with IRESSA

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today received U.S. marketing (PMA) approval of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca’s IRESSA® (gefitinib) in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). QIAGEN’s therascreen EGFR test was approved by the Food and Drug Administration to enable doctors to identify NSCLC patients who have tumors that are positive for epidermal growth factor receptor (EGFR) mutations and therefore are eligible for treatment with AstraZeneca’s drug.

Roche To Develop Companion Diagnostic Test For Acute Coronary Syndrome

Roche (SIX: RO, ROG; OTCQX: RHHBY) recently announced it has entered into an agreement to develop a companion diagnostic (CDx) test for dalcetrapib, a therapeutic from DalCor Pharmaceuticals (DalCor), which will target patients with a specific genotype who have experienced a recent Acute Coronary Syndrome (ACS) event. The CDx test from Roche will be used in a phase III clinical trial that will seek to validate the clinical efficacy of dalcetrapib, an investigational medicine that according to a recently published analysis by the Montreal Heart Institute, could potentially reduce cardiovascular morbidity and mortality by as much as 39 percent in patients with a specific genetic profile.

Ventana Medical Systems, Inc. and Astellas Pharma Join Forces to Leverage Novel Companion Diagnostic Tests for Targeted Cancer Treatments

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced it has entered into master collaboration agreement with Astellas Pharma Inc., an R&D-driven global pharmaceutical company headquartered in Japan, to develop novel automated tissue diagnostics in support of therapeutic compounds in development.

NanoString Technologies Enters into Biomarker Companion Diagnostic Collaboration with Celgene Corporation to Support Development of REVLIMID as Treatment for Patients with Diffuse Large B-Cell Lymphoma

NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that it has entered into a collaboration with Celgene Corporation to develop a companion diagnostic assay using the nCounter® Analysis System to support the clinical validation of REVLIMID® for treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Under the terms of the collaboration agreement, NanoString will develop, seek regulatory approval for, and commercialize the diagnostic test and is eligible to receive payments totaling up to $45 million of which $5.75 million is an upfront payment, $17 million is for potential success-based developmental and regulatory milestones, and the remainder is for potential commercial payments.