Xenofocus Develops Essential Enzyme for COVID-19 Diagnosis

[Asia Economy Reporter Park Hyungsoo] Genofocus announced on the 26th that it has developed a production technology for the enzyme (proteinase K) necessary for molecular diagnosis of the novel coronavirus infection (COVID-19).

COVID-19 is diagnosed through "real-time reverse transcription polymerase chain reaction (RT-PCR)." Total RNA is extracted from specimens collected from suspected patients, and complementary DNA (cDNA) is synthesized using reverse transcriptase (RTase). Then, genes specifically present in the COVID-19 virus are amplified and detected to diagnose infection. Primers in the diagnostic kit specifically bind only to cDNA derived from the COVID-19 virus, amplifying the corresponding genes, allowing highly accurate diagnosis of the presence of the COVID-19 virus in the specimen. If the Ct value, which indicates how many amplification cycles have been performed, is below a certain threshold, the result is positive; if above, negative.

Proteinase K, a proteolytic enzyme, is necessary to efficiently and purely isolate RNA derived from the COVID-19 virus from specimens. Proteinase K is a special enzyme used not only for COVID-19 but also in various diagnostic kits and nucleic acid extraction kits. Domestic diagnostic kit companies import all of it. Globally, only a few companies such as Roche produce it. The price exceeds 100 million KRW per kilogram. Due to the surge in demand for diagnostic kits worldwide amid the COVID-19 pandemic, export restrictions risks have also increased. Currently, there is strong demand for localization to resolve supply issues faced by domestic diagnostic kit companies.

Genofocus, which has been collaborating with domestic diagnostic kit companies, recently succeeded in localizing the production of proteinase K enzyme through intensive research and development at its own research institute.

Kim Euijung, CEO of Genofocus, introduced, "The GF Proteinase K developed by Genofocus is a high-purity product with no DNase or RNase activity and is equal or superior in quality compared to competitors," and added, "It has been commercialized to be available in powder or liquid form depending on the intended use."

He continued, "The enzyme is stable over a wide range of pH and temperature and maintains high activity even in environments containing surfactants and high concentrations of salts," adding, "It is especially useful for on-site diagnostics such as COVID-19 testing conducted in various environments."

Considering the production capacity of Genofocus's enzyme manufacturing plant, it can meet the entire domestic demand amounting to several hundred kilograms. It is also expected to enter the overseas molecular diagnostic market. After completing verification of mass production in large-scale fermenters, discussions are underway with major domestic molecular diagnostic kit companies regarding supply volume and pricing. Full-scale production is expected to begin as early as next month. After completing quality analysis with companies in the Daedeok Research Complex, supply will be made as soon as possible.

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