China's SFDA approves Dynex DS2 ELISA analyzer

Dynex Technologies announced today it has received approval from China's State Food and Drug Administration (SFDA) to market the DS2^® automated enzyme-linked immunosorbent assay (ELISA) analyzer in China. The DS2 is Dynex's industry leading automated ELISA processing system for clinical diagnostic assays, capable of quickly and accurately handling two microplates per assay run, greatly reducing required technician time while improving the speed and reliability of test results. The initial SFDA approval for the DS2 analyzer is effective for four years and allows assay developers, researchers and diagnostic laboratories throughout China to purchase Dynex DS2 systems immediately.

Dynex also announced that it will establish a branch in Hong Kong in the first quarter of 2012 to facilitate its activities and anticipated growth in the rapidly expanding Asia-Pacific market. Heading operations in this region will be Wally Fan, Dynex's new Director of Sales, Asia-Pacific Region. Mr. Fan joins Dynex after a 16-year career with Thermo Fisher Scientific, where he most recently was Commercial Manager, Asia-Pacific and was responsible for sales and marketing of laboratory equipment and consumables. Adrian M. Bunce, Dynex's President, said "I am delighted with the official opening of our Asia-Pacific branch and look forward to replicating our success in this exciting region of the world. I have known Wally for many years and feel very fortunate that Dynex will benefit from his leadership and experience in this area as part of our sales and marketing team."

China's rapid economic development in the last 15 years has had a significant impact on the healthcare and diagnostics sectors. This progress was further accelerated by a 2009 government reform program, increasing funding with the goal of improving both the quality of, and access to, health services. Duane M. Steele, Dynex's Vice President of Sales and Marketing, said "The SFDA approval for DS2 and the opening of our Hong Kong branch demonstrate Dynex's commitment to developing a strong presence in the Chinese market, where the growing use of ELISA tests in many clinical diagnostic applications has highlighted an unmet need for reliable assay automation to maximize the efficient use of laboratory resources. We also expect these developments will pave the way for SFDA approval of Dynex's DSX^® four-plate system, as well as our Agility™ system." Agility is a new fully automated microplate testing system that will be released by Dynex in the third quarter of 2012. The Agility system utilizes state-of-the-art robotics that allows processing of up to 12 microplates in a single run and delivers unparalleled precision while eliminating nearly all manual steps. The greatest level of convenience is achieved when the Dynex SmartKit™ format is utilized with the Agility system. SmartKit packaging is a simple, direct-load solution to assay setup and operation that reduces technician time and the potential for costly data entry errors, while improving ease-of-use and enhancing the product offerings of ELISA reagent kit manufacturers.