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Ventana Paves the Way for Companion Diagnostic Early Phase Clinical Trials in China

Ventana Medical Systems
13 Aug 2014
Sonia Nicholas
Managing Editor and Clinical Lead

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Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, has announced a new agreement with Quintiles, Inc. to offer College of American Pathology (CAP)-standard companion diagnostic testing services in China for pharmaceutical and biotech companies conducting early phase clinical trials. This is great news for patients as China is one of the only countries in the world that requires all patient samples be tested in China, even those used in clinical trials.

"Our new relationship with Quintiles to offer companion diagnostic testing services in China moves our mission, to improve the lives of all patients afflicted with cancer, a big step forward," said Doug Ward, VP and Companion Diagnostics Lifecycle Leader. "Our oncology pharma collaborators can now reach a large and growing number of patients that can benefit from clinical trial participation using targeted treatments and tests.

According to the World Health Organization (WHO)'s latest World Cancer Report, China had the highest rate of new cancer cases recorded globally in 2012 with 21.9%, or 3.07 million, and the trend is increasing, particularly in lung, liver, esophageal and stomach cancers1. This underscores the growing need for patients in China to have in-country access to the most advanced tissue diagnostic testing and companion therapeutics in the industry, which starts with early phase clinical trials.

"It's been extremely important to Ventana that we find a strategic laboratory in China that will help us uphold the CAP testing standard of excellence set by our global companion diagnostic CAP/CLIA laboratory in Tucson, Arizona, USA," said Dr. H. James Hnatyszyn, Director Laboratory Operations for VENTANA companion diagnostic services. "Quintiles has the experience, infrastructure and qualified personnel to meet this challenge"

Early phase clinical trial testing according to the rigorous CAP standards set by Ventana is now available.

About Companion Diagnostics

Companion diagnostics are tests designed to confirm the presence of a specific biomarker and assist physicians in selecting effective therapies for their patients. For pharmaceuticals, incorporating a companion diagnostic strategy into a drug development program may expedite the approval process and help generate more effective drugs with improved safety profiles for patients.



1World Health Organization, World Cancer Report, 2014, Edited by Bernard W. Stewart and Christopher P. Wild

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Companion DiagnosticsCompanion diagnostics are tests, often <i>in vitro</i>, that are used to determine whether a therapeutic product will be safe and effective for use on an individual. They also identify which patients will benefit most from them. Companion diagnostic tests are often developed in conjunction with the pharmaceutical industry.

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