Congratulations! Tarcine's third-generation nasopharyngeal carcinoma diagnostic kit has been approved for market launch
发布时间：2024-11-01 浏览次数：678次 作者：
Recently, the nasopharyngeal carcinoma diagnostic series kit, EB virus Rta protein IgG antibody detection kit (chemiluminescence immunoassay method) independently developed by Tarcine Biomed under Baheal Pharmaceutical Group, has been successfully approved for market by the National Medical Products Administration. This product is the third-generation nasopharyngeal carcinoma diagnostic reagent independently developed by Tarcine BioMed. Based on a fully automatic magnetic particle chemiluminescence platform, the results are more stable and can meet more diverse clinical diagnostic needs.
Tarcine BioMed Inc. is an in vitro diagnostic reagent transformation and industrialization platform that focuses on immune research results. It has a complete IVD product pipeline, application, and industrialization system. Its products focus on disease early screening, precision drug use, tumor efficacy and side effect evaluation and testing. It has launched multiple IVD products and carried out commercialization. In 2009, the first Rta-IgG product independently developed by Tarcine BioMed Inc. was approved for market launch. This product has 7 national patents and has opened up a new path for nasopharyngeal carcinoma screen and diagnosis.
Over the past decade, the first and second generation products of Tarcine Rta-IgG have completed nearly 20 million clinical sample tests. Its pioneering Rta-IgG combined with EA-IgA and VCA-IgA triple detection mode has become the main combination method for nasopharyngeal carcinoma screening, benefiting numerous patients and establishing a solid customer reputation in the field of nasopharyngeal carcinoma screening.
The third generation products approved this time also include two products in the same series: EB virus early antigen (EA) IgA antibody detection kit (chemiluminescence immunoassay method) and EB virus capsid antigen (VCA) IgA antibody detection kit (chemiluminescence immunoassay method). Unlike other EA-IgA and VCA-IgA kits already on the market, these two kits are indicated for nasopharyngeal carcinoma auxiliary diagnosis and have been validated by prospective clinical studies conducted by authoritative hospitals such as Sun Yat-sen University Cancer Center and Guangxi Zhuang Autonomous Region People's Hospital.
In recent years, the clinical application of Rta-IgG as a biomarker for nasopharyngeal carcinoma has been continuously expanding, and the molecular biology mechanism of Rta protein induced occurrence and development of nasopharyngeal carcinoma has also been deepening. Multiple studies have elucidated the molecular mechanism of Rta induced nasopharyngeal carcinoma, laying a solid theoretical foundation for the application of Rta-IgG in nasopharyngeal carcinoma detection. With the successful launch of the third-generation product, Tarcine will also make more contributions to early screening, diagnosis, and treatment of nasopharyngeal carcinoma.
In addition, the third-generation product is based on a fully automated chemiluminescence platform. Compared with the previous generation enzyme immunoassay method, the experimental process is fully automated, resulting in more stable results and smaller deviation. The detection results can be quantified based on qualitative analysis, resulting in more accurate results. The sample types have been increased to serum and plasma to meet customers' diverse choices.
In the future, Tarcine will continue to rely on the industrial resources and innovation incubation capabilities of Baheal Pharmaceutical Group, cooperate with national scientific universities and clinical medical institutions, develop more in vitro diagnostic reagent products with independent intellectual property rights, and effectively optimize medical scenarios.