LabGenomics Requests Emergency Use Authorization from US FDA

[Asia Economy Reporter Minji Lee] LabGenomics, a molecular diagnostic healthcare specialist company, announced on the 17th that it has received a request from the US FDA to apply for Emergency Use Authorization (EUA) for its COVID-19 diagnostic kit.

LabGenomics plans to start full-scale sales in the US once FDA approval is completed. The company is currently negotiating meeting schedules with the CDC (Centers for Disease Control and Prevention).

The diagnostic kit developed by LabGenomics, LabGun COVID-19 Assay, is based on the core technology of Real-time Polymerase Chain Reaction (Real-time PCR). This is currently the most widely used technology in nucleic acid-based in vitro diagnostics, offering a testing time within 2 hours and maintaining an accuracy rate of over 99%. Since its establishment in 2002, LabGenomics has developed and commercialized gene testing reagents and diagnostic systems based on genome analysis and polymerase chain reaction methods.

The company has signed contracts with local dealers in the Middle East, Greece, and Italy, supplied initial shipments, and expects additional large orders due to the global spread trend.

Additionally, there have been sales requests for COVID-19 diagnostic kits from more than 30 countries including Canada, Australia, Japan, Spain, France, Israel, UAE, South Africa, Czech Republic, Uzbekistan, Croatia, Malaysia, Vietnam, Thailand, the Philippines, and Myanmar. LabGenomics is currently negotiating with the governments or local dealers of these countries, and large-scale orders are expected.

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