Tag Archives: Ventana Medical Systems—

November 2016—Horizon Discovery has entered into a co-development and commercialization agreement with Ventana Medical Systems, a member of the Roche group. The agreement covers the development, manufacture, and commercialization of cell-line derivative materials for use as immunohistochemistry reference standards in cancer tissue diagnostics to support the development and validation of IHC assays.

Sept. 14, 2016—Horizon Discovery Group has entered into a co-development and commercialization agreement with Ventana Medical Systems, a member of the Roche Group. The agreement covers the development, manufacture, and commercialization of cell-line derivative materials for use as IHC reference standards in cancer tissue diagnostics to support the development and validation of IHC assays. Ventana provides products used in clinical ...

July 2015—Halozyme Therapeutics and Ventana Medical Systems announced a global agreement to collaborate on the development of a companion diagnostic assay for use with Halozyme’s investigational new drug, PEGPH20, which Ventana would ultimately commercialize.

June 2015—Ventana Medical Systems has entered into a master collaboration agreement with Astellas Pharma, a research-and-development–driven pharmaceutical company headquartered in Japan, to develop novel automated tissue diagnostics in support of therapeutic compounds in development.

June 15, 2015—Ventana Medical Systems announced the FDA’s approval of the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to help identify patients for crizotinib, marketed as Xalkori by Pfizer. The Ventana ALK Assay was approved as a CE-IVD in Europe in 2012 and was approved by the Chinese Food and Drug Administration in 2013. With this class III ...

November 2014—Ventana Medical Systems announced that its Ventana System for Primary Diagnosis has been CE marked in the European Union for routine pathology, including for primary diagnosis with human tissue specimens.

November 2014—Ventana Medical Systems announced that its Ventana System for Primary Diagnosis has been CE marked in the European Union for routine pathology, including for primary diagnosis with human tissue specimens.

August 2014—Ventana Medical Systems launched three robust prototype assays for the detection of biomarkers PSMA (prostate specific membrane antigen), MDM2 (mouse double minute 2), and FGFR (fibroblast growth factor receptor 2).

February 2014—Ventana Medical Systems received 510(k) clearance from the FDA for the Companion Algorithm ER (SP1) image-analysis algorithm used with the Ventana iScan Coreo scanner running Virtuoso software.

February 2014—Ventana Medical Systems’ HER2/neu (4B5) Rabbit Monoclonal Primary Antibody assay is a companion diagnostic for detecting HER2 protein expression in patients who, in countries where the drugs are approved, may be appropriate candidates for Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine).