Wells Bio, a subsidiary of Access Bio, has completed the research and development of the independently developed monkey smallpox diagnostic reagent ‘careGENETM MPXV detection kit,’ a high-speed automatic extraction equipment (careSTARTTM P1 System) and reagents (careGENETM HiFi Nucleic Acid Isolation kit for P1 system). announced on the 1st that it has obtained domestic approval for
‘careGENETM MPXV detection kit’ is a one-step kit that uses viral DNA extracted from patient’s blood to check whether or not infected with monkey pox virus. This product is designed in a multi-diagnostic method to enable specific detection and differentiation of Orthopoxviruses, including smallpox, monkeypox, and vaccinia viruses, and monkeypox virus found in western and central Africa. The accuracy was improved and the inspection time was advanced to about 70 minutes. In the future, once samples are secured, export licenses will be granted through rapid clinical verification, and overseas sales will be promoted through this.
Meanwhile, on May 29 (local time), the World Health Organization (WHO) raised the public health risk level of monkeypox that has occurred in 23 countries around the world to level 2, which is an intermediate level.
“The public health risk could increase if the virus shows signs of becoming a human pathogen and spreads to high-risk groups such as children and patients taking immunosuppressants,” the WHO said.
A Wells Bio official said, “Wells Bio is actively investing in R&D to respond to new strains of infectious disease, and it was confirmed that the monkey smallpox can also be detected at a low concentration of ‘5 copies/reaction’ during self-verification through a quick response. Because smallpox virus has a long incubation period, it is very important to make early diagnosis with high-sensitivity molecular diagnostic RT-PCR products in order to avoid another pandemic.”
The ‘gene extraction equipment (careSTARTTM P1 System, in vitro preparation No. 22-856) and extraction reagent (careGENE™ HiFi Nucleic Acid Isolation kit for P1 system, in vitro preparation No. 22-782), which was approved for domestic sales by the Ministry of Food and Drug Safety this time, are It is a high-speed automated gene extraction equipment launched targeting advanced markets such as the United States and Europe, and is expected to enhance the convenience of testing because it is simple to use. This equipment obtains genetic material (DNA or RNA) from various samples of patients in about 20 minutes, shortening the overall examination time for diseases, and is a reagent that can increase accuracy. . Access Bio, the parent company, plans to focus on marketing through various distribution networks in cooperation with Pharmgen Science.
Wells Bio is a subsidiary of Access Bio, a KOSDAQ-listed U.S. corporation that Pharmgene Science acquired the largest stake in. It is a diagnostic product development and production company established in 2013 for the purpose of developing next-generation diagnostic products.
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