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Kalorama Report: Next Gen Sequencing Will Determine Growth in IVD Testing Market

Not since the commercialization of polymerase chain reaction tests has molecular diagnostics been presented with such a promising technology as next-generation sequencing (NGS), according to healthcare market research firm Kalorama Information.  NGS’s blue-chip status was discussed in the recently published The Worldwide Market for In Vitro Diagnostics, 9th Edition.

Ventana Companion Diagnostics CAP/CLIA lab launches new Robust Prototype Assays

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced the launch of three new companion diagnostic robust prototype assays (RPAs) for the detection of biomarkers PSMA, MDM2 and FGFR, offering biotech and pharmaceutical companies more options in exploring novel treatment options for patients with cancer. The new assays bring the company’s CAP/CLIA testing menu to almost 400, nearly 100 of which are RPA assays and the remainder are IVD approved Ventana tests.

Ganymed Pharmaceuticals Announces CE Marking for Test to Assess Claudin-18.2 Expression in Solid Tumors

Ganymed Pharmaceuticals announced today that it has fully developed and obtained CE marking for its in vitro diagnostic (IVD) test CLAUDETECTTM18.2 which allows to assess the expression levels of Claudin-18.2 (CLDN18.2) in solid tumors. CLAUDETECTTM18.2, which was developed in collaboration with Theracode GmbH, is now compliant with the requirements of European Community Directive 98/79/EC on in vitro diagnostic medical devices.

Nuclea Bio Acquires Oncogene Science, Extends Deal with Wilex

Just a few months after announcing several new partnerships and landing venture capital dollars, Nuclea Biotechnologies Inc. has snapped up Oncogene Science, an Cambridge, Mass.-based subsidiary of Wilex AG in Germany.

Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.