{"id":22577,"date":"2025-01-22T13:48:36","date_gmt":"2025-01-22T05:48:36","guid":{"rendered":"https:\/\/flcube.com\/?p=22577"},"modified":"2025-01-22T13:48:38","modified_gmt":"2025-01-22T05:48:38","slug":"kehua-bioengineering-gains-nmpa-approval-for-gene-polymorphism-detection-kits","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22577","title":{"rendered":"Kehua Bioengineering Gains NMPA Approval for Gene Polymorphism Detection Kits"},"content":{"rendered":"\n

China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022<\/a>) has announced receiving marketing approvals from the National Medical Products Administration (NMPA) for its human CYP2C9 gene polymorphism detection kit and human VKORC1 gene polymorphism detection kit, both utilizing the fluorescence PCR method. These approvals mark a significant advancement in personalized medicine, particularly in optimizing warfarin dosing.<\/p>\n\n\n\n

Kit Details and Applications<\/strong>
The human CYP2C9 gene polymorphism detection kit is designed for in vitro qualitative detection of CYP2C9 gene genotypes at the c.430C>T and c.1075A>C loci in human whole blood genomic DNA samples. Meanwhile, the human VKORC1 gene polymorphism detection kit is used for in vitro qualitative detection of the VKORC1 gene c.1639G>A genotype in genomic DNA from human venous whole blood samples. These kits provide critical genetic information that can assist clinicians in quickly determining the initial dose of warfarin and predicting potential drug toxicity.<\/p>\n\n\n\n

Clinical Impact<\/strong>
In clinical settings, the detection of CYP2C9 and VKORC1 gene polymorphisms is essential for optimizing warfarin therapy. Combined with International Normalized Ratio (INR) test values, these genetic tests can help estimate the maintenance dose of warfarin, ensuring medication safety and reducing the risk of adverse events. The approvals of these kits underscore Kehua Bioengineering’s commitment to advancing personalized medicine in China.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022) has announced receiving marketing approvals from the…<\/p>\n","protected":false},"author":1,"featured_media":22579,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[611,15,1308],"class_list":["post-22577","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-kehua-bioengineering","tag-product-approvals","tag-she-002022"],"yoast_head":"\nKehua Bioengineering Gains NMPA Approval for Gene Polymorphism Detection Kits - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022) has announced receiving marketing approvals from the National Medical Products Administration (NMPA) for its human CYP2C9 gene polymorphism detection kit and human VKORC1 gene polymorphism detection kit, both utilizing the fluorescence PCR method. 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