Framingham, MA and Shanghai, CN — SCIEX Dignostics, the in vitro diagnostics (IVD) division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced today that it has formed a joint venture (JV) with Zhejiang Dian Diagnostics (Dian), a leader in the research, development and supply of medical diagnostic products and services in China. 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 that was 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.
As one of the leading diagnostic companies in China, 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 wide 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 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."
A ceremony celebrating the venture will take place at Zhejiang Dian Diagnostics headquarters in Hangzhou, China, on November 11, 2017 attended by SCIEX Senior Leadership Executives.