SML Genetree Ezplex SARS-CoV2/RV Fast G Kit receives official authorization from MFDS
SML Genetree has received official authorization from the South Korean Ministry of Food and Drug Safety (MFDS) on June 21, for the Ezplex® SARS-CoV2/RV Fast G Kit that detects and differentiates four viruses, including the SARS-CoV-2 Virus, Influenza A, Influenza B and RSV A/B in one test with a result turnaround time of approximately 35 minutes post extraction.
Unlike existing single pathogen COVID-19 diagnostic tests, the Ezplex® SARS-CoV2/RV Fast G Kit is a multiplex real-time PCR test that simultaneously diagnoses four different respiratory viruses within 35 minutes post extraction, combining SML Genetree’s multiplexing and Fast PCR technologies. Most of the multiplex test kits previously registered with the Korean MFDS that simultaneously detect the SARS-CoV-2 Virus along with other respiratory viruses target three viruses (SARS-CoV-2, Influenza A and Influenza B). The only two test kits that include Respiratory Synctial Virus (RSV), which causes severe capillary bronchopneumonia and is fatal to infants, are Allplex by Seegene and Ezplex by SML Genetree.
The Ezplex® SARS-CoV2/RV Fast Kit demonstrated 100% analytical sensitivity and 100% specificity, after reducing the PCR result turnaround time from 2-4 hours to 35 minutes. Since this is only a few minutes different than the self- testing rapid COVID-19 antigen test kits currently in use and considered a standard for rapid COVID-19 tests, this Ezplex test could be utilized for various applications ways during the second half of the year such as screening prior to students’ daily commutes, the national college entrance exam, and overseas travel .
SML Genetree is recognized as having a broad molecular diagnostic portfolio of both PCR and NGS tests. They are also anticipating a patent application covering original technology as well as the release of new products in the second half of the year, based on results from their research on nanotechnology and point-of-care-testing (POCT) products, raising market expectations.
Based on these achievements, SML Genetree has been recognized as high value by many large pharmaceutical companies as well as multiple listed bio groups, KOSDAQ listed corporations, and VC’s in South Korea-- successfully finishing a Pre-IPO round and preparing for entry into KOSDAQ in 2022 with Mirae Asset Securities as their advisor.
Jihoon Ahn, the CEO of SML Genetree, said “The SARS-COV-2 Delta Variant is increasing in prevalence, but COVID-19 vaccination rates have also been accelerating so we are hopeful for herd immunity in South Korea within the year. Even though we are in the molecular diagnostics sector, the company’s performance is continuing to grow at a fast pace regardless of the progression rate of COVID-19, and we are confident we will be recognized for our true value in the post-COVID era.”
Excerpted from 2021.06.29 // Money Today // Namyi Heo (email@example.com)