Wells Bio, a subsidiary of Access Bio, said Thursday that it would start exporting a COVID-19 diagnostic kit, named careGEN N-CoV RT-PCR Kit, as it has received export approval from the Ministry of Food and Drug Safety.
The company obtained the Conformite Europeenne (CE) mark for its diagnostic kit on March 3.
"Wells Bio's COVID-19 diagnostic kit has demonstrated high sensitivity in a comparative study by a clinical research institute, as part of its effort to pass a more stringent process for exporting diagnostic reagents set by the ministry," the company said. "We plan to distribute the product in various countries based on the latest go-ahead from the ministry."
Wells Bio said it also completed the registration of the "CareGENE Viral/Pathogen Nucleic Acid Isolation Kit," a gene extraction kit for PCR equipment used for the test of COVID-19, on Monday.
According to the company, the conventional diagnostic kit used for COVID-19 detection conducts its test by using RNA extracted from a sample such as a nasopharyngeal swab or sputum.
However, Wells Bio's gene extraction kit is capable of extracting 96 samples simultaneously without pre-treatment and using automated equipment, which will significantly contribute to shortening the inspection speed.
Besides launching its kit globally, the company has also been selected as a participant in the government’s emergency project to develop and commercialize an immune diagnostic equipment for detecting COVID-19 antigen protein.
Wells Bio plans to develop an immunodiagnostic kit for COVID-19 antigens with high sensitivity by using Access Bio's influenza diagnostic kit, which has won a nod from the U.S. Food and Drug Administration, the company added.
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