Molecular diagnostic product identifies HPV infection and genotypes; secures Class II medical device approval in Mexico.
Company plans to pursue further approvals for infectious disease and cancer diagnostic products to accelerate Latin American market expansion.
HLB Panagene announced on the 11th that it has received product approval in Mexico for its human papillomavirus (HPV) molecular diagnostic product, the 'PANA RealTyper HPV Kit.' The company intends to leverage this approval to strengthen its local business foundation and expand its presence in the Latin American in-vitro diagnostics market.
The product, approved by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS), is classified as a Class II medical device under the local regulatory framework, which categorizes medical devices into three classes based on risk levels.
The 'PANA RealTyper HPV Kit' is designed to detect HPV, the primary cause of cervical cancer. By utilizing Multiplex PCR technology, the kit can identify both the presence of the virus and its specific genotype.
Mexico is considered a key in-vitro diagnostics market in Latin America. According to global market research firm Coherent Market Insights, the Mexican in-vitro diagnostics market is projected to reach approximately $1.32 billion by 2026, with an expected compound annual growth rate (CAGR) of 8.5%.
HLB Panagene plans to use this approval as a springboard to increase local product supply and extend its business reach to other major Latin American countries. The company is also pursuing regulatory approval in Mexico for its other domestically approved molecular diagnostic products for infectious diseases and cancer.
Jang In-keun, CEO of HLB Panagene, stated, "This Mexican product approval serves as a significant milestone for expanding our molecular diagnostics business in Latin America. We will continue to pursue product approvals and commercialization to meet local market demand and strengthen our competitive edge in the region."
