Original from: Devyser
Devyser has achieved a significant regulatory milestone with 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. Rapid prenatal aneuploidy detection kits fall under Class III IVD as part of the NMPA product registration process. This approval enables Devyser to market Devyser Compact as an in vitro diagnostic in China and paves the way for future regulatory approvals in the region for its simple, fast, and accurate genetic testing solutions.
"Devyser has been engaged in extensive efforts to obtain regulatory approval for its products, and it¡¯s therefore great to see that after several years of hard work, we have successfully obtained market registration in China. Based on this regulatory approval, we are optimistic about the potential of this product in China. This first product approval by the NMPA gives us confidence that several more products will be approved in the future in China. I am very proud of the team who made this happen," says Devyser's CEO, Fredrik Alpsten.
Devyser Compact is IVDR-certified and measures the most common chromosomal abnormalities, such as Down syndrome, and also includes patented technology for safe detection of Turner syndrome. Devyser's single-tube kit is easy to use, requires minimal manual handling, provides fast results and reduces the risk of mixing samples. Utilizing a single-tube PCR process minimizes hands-on time, reduces the risk of sample mix-up, and allows laboratories to efficiently analyze chromosomes 13, 18, 21, and XY with 26 highly informative genetic markers. This patented technology enables accurate, reliable diagnoses, including a dedicated method for Turner syndrome detection. Its streamlined, low-DNA-requirement workflow is fully validated under IVDR, offering labs a fast, standardized solution for critical prenatal insights. Devyser Compact is now the leading standard for prenatal diagnosis in several European countries.
Source: Devyser Compact achieves Class III approval in China
