Wells Bio, a subsidiary of Access Bio, said Tuesday that its careGENE Zika Virus RT-PCR Kit has received Emergency Use Assessment and Listing (EUAL) from the World Health Organization.
WHO has set up the EUAL as an extraordinary process intended to guide interested U.N. procurement agencies and national regulatory authorities of its member states on the quality, safety and performance of certain In Vitro Diagnostics (IVDs).
The company’s product, which is the fourth registered device listed on EUAL, is a one-step kit for confirming the infection with Zika virus using viral ribonucleic acid (viral RNA) extracted from the patient's serum.
Wells Bio has designed the kit to detect two genomic areas to increase accuracy and improve the effectiveness of the sample through internal control of the product. The company has verified the kit’s performance through clinical trials in Colombia and Korea.
“WHO's approval for EUAL has allowed the company to expand its sales territory into the overseas market,” a company official said. “Our kit has an open system that is compatible with most amplifiers and does not incur additional costs for the instrument.”
The company believes that the kit will have sufficient competitiveness in the global diagnostic market as it has shortened the inspection time while ensuring performance and convenience, he added.