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Diagnostics companies combine to address diagnostic and wellness testing.
December 12, 2017
By: Business Wire
SCIEX Diagnostics, the in-vitro diagnostics (IVD) division of SCIEX, has formed a joint venture with Zhejiang Dian Diagnostics (Dian), a leader in the research, development and supply of Chinese medical diagnostic products and services. The parties plan to jointly establish a joint venture in Hangzhou, China, to develop, register, manufacture, and commercialize Class I, II, and III in-vitro diagnostic reagents for the SCIEX Triple Quad 4500MD LC-MS/MS system, a solution approved by the China Food and Drug Administration (CFDA) earlier this year. Mass spectrometry is known to achieve the high sensitivity, specificity and throughput needed in clinical testing areas such as therapeutic drug measurement, vitamin and steroid hormones, and measurements of inherited metabolic diseases, but the lack of readily available IVD assays has made this technology inaccessible to the majority of hospital labs in China where lab-developed tests (LDT) are limited. By combining SCIEX LC-MS/MS and assay development expertise, with Dian’s laboratory network, cold chain logistics, and China-IVD manufacturing expertise, it is expected that the partnership will accelerate China’s clinical laboratory program and make diagnostic and wellness testing more widespread in the region. Dian’s diagnostic network stretches to more than 30 laboratories, covering almost all of mainland China, processing more than 100,000 clinical samples per day. To advance clinical diagnostics in China, Dian has also established “precision treatment centers” with high-end “Tier 3” medical institutions, and has a developed a comprehensive service for secondary-level Tier 2 hospitals and beyond. “Modern-day China contends with many lifestyle factors that can lead to illness. Our aim is to provide wellness testing resources that can help hospitals identify potential health risks before they become chronic,” said Inese Lowenstein, president of SCIEX. “Dian has established many product channels with its coverage of high-end medical resources, and this venture will further enrich their existing in-vitro diagnostic product lines to enable hospital labs to expand their testing capabilities, and perform tests that they previously were not able to.” “It is an important decision and major breakthrough for Dian to collaborate with SCIEX to promote the industrialization and localization of clinical mass spectrometry,” said Hai bin Chen, chairman of Zhenjang Dian Diagnostics. “This joint venture is the first of its kind in China, and by also working closely with CFDA and Health and Family Planning Commission, we believe it will have a profound influence on the future of wellness and diagnostic testing in China.” SCIEX helps to improve the world by enabling scientists and laboratory analysts to find answers to complex analytical challenges. The company’s service and support in the capillary electrophoresis and liquid chromatography-mass spectrometry industry have made it a partner to scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics, and clinical research. AB Sciex is operating as SCIEX.
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