WellsBio Completes Export Approval and European Certification for COVID-19 Diagnostic Kit

[Asia Economy Reporter Koo Eun-mo] WellsBio, a subsidiary of Access Bio, announced on the 19th that it has received export approval from the Ministry of Food and Drug Safety for the novel coronavirus (COVID-19) diagnostic kit 'careGENE™ N-CoV RT-PCR Kit.' WellsBio had already obtained European certification (CE) for the COVID-19 diagnostic kit on the 3rd.

WellsBio's COVID-19 diagnostic kit demonstrated high sensitivity in comparative tests conducted by a clinical trial specialized institution to meet the strengthened requirements for export approval. Based on the Ministry of Food and Drug Safety's export approval, the company plans to sequentially supply the kit to various countries.

Additionally, WellsBio announced on the 16th that it has completed the Class 1 notification with the Ministry of Food and Drug Safety for the gene extraction kit for PCR equipment used in COVID-19 testing (careGENE™ Viral/Pathogen Nucleic Acid Isolation kit).

Generally, COVID-19 diagnostic kits use RNA extracted from specimens such as nasopharyngeal swabs or sputum for testing, whereas WellsBio's gene extraction kit utilizes automated equipment to simultaneously extract 96 samples without preprocessing, which is expected to contribute to improved testing speed when used.

Last month, WellsBio was selected as a participating company in an emergency national project and is currently conducting the project 'Development and Commercialization of Immunodiagnostic Kits for COVID-19 Antigen Protein Detection.' The company plans to develop a highly sensitive COVID-19 antigen immunodiagnostic kit by applying the platform used in its parent company Access Bio's influenza antigen diagnostic kit (FDA approved).

WellsBio focuses on the development and sales of biosensors, rapid immunodiagnostics, and molecular diagnostic test kits. Its main products include glycated hemoglobin (HbA1c), G6PD biosensors, dengue immunodiagnostic kits, influenza rapid diagnostic kits, malaria rapid diagnostic kits, STD-12 diagnostic kits for 12 sexually transmitted diseases, Zika virus diagnostic kits, and cervical cancer (HPV) diagnostic kits.

This content was produced with the assistance of AI translation services.