GenoFocus Develops Production Technology for 'Proteinase-K', Essential Enzyme for COVID-19 Test Kits

GenoFocus headquartered in Daedeok Innopolis in Daejeon has successfully developed the technology to produce 'Proteinase-K', an essential enzyme used in molecular diagnostic kits for COVID-19 that has been entirely imported until now.

COVID-19 testing involves a real-time reverse transcription polymerase chain reaction (RT-PCR). RNA is extracted from a sample collected from the person suspected to be infected and used to synthesize complementary DNA with a reverse transcriptase (RTase). Afterwards, the genes specific to the COVID-19 virus are amplified and detected to see whether the person has the virus. The primer in the diagnostic kit specifically bind to the cDNA derived from the coronavirus and amplify the genes, so it can detect the presence of the virus in the sample with high accuracy. If the Ct value, which represents how much the amplification process has been performed, is lower than a certain level, it is judged as a positive, and if it is higher, it is judged as a negative.

'Proteinase-K' is an enzyme that breaks down proteins, and it is essential for separating the RNA from the coronavirus in a highly efficient and pure manner. Plus, it is used as a special enzyme in various other diagnostic kits and nucleic acid extraction kits, but all the domestic diagnostic kit manufacturers have had no choice but to import it. It is currently commercially produced by only a few companies, such as Roche (Swiss pharmaceutical company), and due to the high price tag, which is well over KRW 100 million per kilogram and the explosive growth of demand for diagnostic kits around the world due to the COVID-19 pandemic, raising the risk of export restrictions, there has been a strong demand for localization to meet the demand of domestic diagnostic kit companies.

Amid this trend, GenoFocus, which had been working closely together with domestic diagnostic kit manufacturers, conducted an intensive R&D project in its own research lab and successfully localized 'Proteinase-K'. GenoFocus CEO Kim Eui-joong said, "GF Proteinase-K developed by GenoFocus has no DNAse and RNAse activity and is a high-purity product that is equivalent or superior to our competitors’ products. It can be used in power or liquid form depending on the purpose of us. The enzyme remains stable over wide ranges of pH and temperature and maintains high activity even in environments where there are surfactants and high salt concentrations, making it particularly useful for point-of-care diagnostics, such as COVID-19 testing."

Considering the current production capacity of GenoFocus’s enzyme production plant, it is expected to be able to fully handle the domestic demand for hundreds of kilograms of 'Proteinase-K' (≒ tens of millions of dollars), and even export to the overseas molecular diagnostics market. The company will begin full-fledged production after verifying the mass production capacity of large-capacity fermentation equipment.

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