Congratulations! Tarcine BioMed’s Third-Generation Nasopharyngeal Cancer Diagnostic Kit Receives Approval
Release Time:2024-11-01 View Count:46

Tarcine BioMed, a subsidiary of Baheal Pharma Group, has announced that its independently developed EB Virus Rta Protein IgG Antibody Detection Kit (Chemiluminescent Immunoassay) has been approved by the National Medical Products Administration. This third-generation diagnostic kit for nasopharyngeal cancer, based on a fully automated magnetic particle chemiluminescence platform, offers more stable results and meets diverse clinical diagnostic needs.

 

 
Tarcine BioMed is a platform dedicated to the transformation and commercialization of in vitro diagnostic (IVD) reagents focused on immunological research findings. The company boasts a comprehensive system for IVD product development, regulatory approval, and industrialization. Its product portfolio targets early disease screening, precision medication, and assessment of tumor treatment efficacy and side effects. Tarcine BioMed has successfully commercialized multiple IVD products. In 2009, Tarcine BioMed's first independently developed Rta-IgG product was approved for market release. This pioneering product holds seven national patents and established a new pathway for the auxiliary diagnosis of nasopharyngeal carcinoma.

 

Over the past decade, Tarcine BioMed's first- and second-generation Rta-IgG products have collectively completed nearly 20 million clinical sample tests. The pioneering Rta-IgG, combined with EA-IgA and VCA-IgA in a triple test, has become the primary method for nasopharyngeal carcinoma screening, benefiting numerous patients and establishing a strong reputation in the field.

 

The newly approved third-generation product line also includes the EB Virus Early Antigen (EA) IgA Antibody Detection Kit (Chemiluminescent Immunoassay) and the EB Virus Capsid Antigen (VCA) IgA Antibody Detection Kit (Chemiluminescent Immunoassay). Unlike other EA-IgA and VCA-IgA kits on the market, these two kits are specifically indicated for the auxiliary diagnosis of nasopharyngeal carcinoma. They have been validated through prospective clinical studies at prestigious institutions such as the Sun Yat-sen University Cancer Center and the People's Hospital of Guangxi Zhuang Autonomous Region.

 

Additionally, the third-generation product is based on a fully automated chemiluminescence platform. Compared to the previous ELISA method, this new platform enables fully automated operation, resulting in more stable and accurate outcomes with reduced error. The test results can be quantified, providing greater precision. Furthermore, the range of sample types has been expanded to include both serum and plasma, catering to a broader range of user preferences.

 

In recent years, the clinical application of Rta-IgG as a biomarker for nasopharyngeal carcinoma has significantly expanded. Research has continued to delve into the molecular mechanisms by which the Rta protein induces the development of nasopharyngeal carcinoma, establishing a solid theoretical foundation for the use of Rta-IgG in its detection. With the successful launch of the third-generation products, Tarcine BioMed is set to make further contributions to the early screening, diagnosis, and treatment of nasopharyngeal carcinoma.

 

Future efforts at Tarcine BioMed will strategically build on the vast industry resources and innovation capacity of Baheal Pharma Group. By partnering with top national research institutions and clinical medical centers, we are committed to developing more proprietary in vitro diagnostic products, thereby enhancing medical diagnostics and improving patient care.

 

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