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Devyser Secures NMPA Approval for Devyser Compact, Expanding Genetic Testing Market in China

NextEdge Admin

29 Oct 2024

2 min 9 sec

chromosomal abnormalities,Devyser,genetic testing

Devyser has achieved a key regulatory milestone by securing its first market registration from China’s National Medical Products Administration (NMPA) for Devyser Compact, an IVDR-certified genetic test for detecting fetal chromosomal abnormalities. As a rapid prenatal aneuploidy detection kit, it falls under Class III IVD in the NMPA registration process. This approval enables Devyser to market its product in China, setting the stage for future regulatory successes in the region.

“This milestone reflects years of dedication and effort,” said Fredrik Alpsten, CEO of Devyser. “We are confident that this approval will unlock opportunities for other products in the Chinese market. I am extremely proud of the team for making this happen.”

Devyser Compact is designed to detect common chromosomal abnormalities, including Down syndrome, and incorporates patented technology for accurate detection of Turner syndrome. The test offers a user-friendly, single-tube PCR workflow that minimizes manual handling and the risk of sample mix-ups. It analyzes chromosomes 13, 18, 21, and XY using 26 highly informative genetic markers, providing fast and reliable results.

With its streamlined, low-DNA-requirement process, Devyser Compact is fully validated under IVDR standards, offering laboratories a fast and standardized approach to prenatal diagnostics. Already a leading prenatal testing solution across several European countries, this approval in China strengthens Devyser’s position in the global genetic testing market.