HLB Panagene Receives Marketing Authorization in Mexico for HPV Diagnostic Product

HLB Panagene has received marketing authorization from Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) for its human papillomavirus (HPV) molecular diagnostic product.

According to HLB Panagene on November 11, the newly authorized product is an in vitro diagnostic medical device classified as Class II under Mexico's medical device classification system. Mexico classifies medical devices into Classes I to III according to risk level.

The PANA RealTyper HPV Kit is a molecular diagnostic product that detects HPV, a virus known to be a major cause of cervical cancer. Using multiplex polymerase chain reaction (Multiplex PCR) technology, it can determine whether a person is infected with HPV and identify the virus's genotype.

With the authorization of this HPV diagnostic product, HLB Panagene plans to expand its product portfolio in Mexico while gradually broadening its business into Latin America. The company is also pursuing local regulatory approvals in Mexico for its infectious disease and cancer molecular diagnostic products that have been authorized in Korea. Its strategy is to build on the business foundation established in Mexico to expand into major countries across Latin America.

"This marketing authorization in Mexico will be an important opportunity to expand our molecular diagnostics business in the Latin American market," said Jang Ingeun, CEO of HLB Panagene. "We will continue to pursue product approvals and commercialization in line with local market demand and strengthen our business competitiveness across Latin America."

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