Sansure Biotech Inc. (SHA: 688289), a specialist in molecular diagnostics based in China, has achieved a regulatory milestone with the National Medical Products Administration (NMPA) granting marketing approval for its in-house developed human MTHFR gene polymorphism nucleic acid detection kit, which utilizes the PCR fluorescent probe method. This product is recognized as China’s first dual sample assay for folate metabolism, applicable to both peripheral blood and oral swab samples.
The detection kit is designed for the qualitative detection of the C677T polymorphism in the MTHFR gene, found in human peripheral blood and oral swab samples. It aids clinicians in assessing the activity levels of methylenetetrahydrofolate reductase, guiding folate supplementation, and managing overall health during pregnancy. The product is instrumental in effectively preventing and reducing pregnancy complications associated with the MTHFR gene polymorphism, thereby enhancing pregnancy quality and birth outcomes, and safeguarding the health of both mother and child.
MTHFR (methylenetetrahydrofolate reductase) is a crucial enzyme in folate metabolism, and variations such as the C677T polymorphism can result in reduced enzyme activity, impacting folate metabolism and potentially influencing pregnancy outcomes.- Flcube.com