Dynex Technologies has secured approval from the Chinese Food and Drug Administration (CFDA) to supply its AGILITY instrument and software in China.


Image: Dynex secures approval for AGILITY to be launched in China. Photo: Courtesy of Louis Reed/Unsplash.

Dynex stated that AGILITY has been designed for quantitative immunoassay measurements of analytes, including proteins and microbiological specimens.

AGILITY is a fully automated platform for enzyme-linked immunosorbent assay (ELISA). It has been designed to simplify, offering an intuitive easy-to-use interface.

The product support several error-proofing advances, including comprehensive monitoring system to measure consumable levels and extensive bar coding to eliminate manual data entry.

Furthermore, the solution streamlines front-end preparation and reduces hands-on reagent loading with revolutionary, direct-load reagent SmartKits, minimizing overall assay times and offering full walk-away freedom.

It uses three robotic arms, one for sample pipetting, one for reagent pipetting and another for transporting plates and consumables. These arms help in attaining maximum process efficiency and precision while eliminating nearly all manual steps and reducing the potential for human error.

ELISA is a commonly used analytical biochemistry assay. The assay uses a solid-phase enzyme immunoassay (EIA) to detect the presence of a protein in a liquid sample.

Dynex stated that its portfolio approval demonstrates dedication to clinical labs in the Asia-Pacific region.

Dynex Technologies CEO David Sholehvar said: “With the approval of DYNEX AGILITY, we now offer a fully automated solution for high-volume immunoassay testing in the rapidly growing in-vitro diagnostics (IVD) market in China. As an open platform, AGILITY allows our customers to select the assays which work best for them across many disease states.

“This enables labs to meet increased testing demands from the growth in aging populations and subsequent increase in diagnostic needs for chronic and infectious diseases, as well as cancer and other important disease states.”

Dynex has an instrument base of more than 7,500 systems across the globe. It has multidisciplinary staff of nearly 140 people globally, including design and service engineers, applications scientists, marketing, sales specialists, and precision-manufacturing experts.

The company is engaged in the product design and new applications frontiers to deliver latest microplate processing systems.