Genematrix's said Tuesday that it has recently won the CE-IVD certification for its new coronavirus test kit, NeoPlex COVID-19. CE-IVD is Conformite Europeen In-Vitro Diagnostic Medical Device Directive.
Genematrix, a molecular diagnostics service company, will globally supply NeoPlex COVID-19, which significantly reduces the diagnostic time from six to three hours. It also can secure the simplicity and efficacy of large-capacity testing with accumulated molecular diagnostic technology.
|Genematrix's new coronavirus diagnostic kit NeoPlex COVID-19|
Currently, the two primary COVID-19 testing methods for quick diagnosis follow the standards of either the World Health Organization or the U.S. Centers for Disease Control and Prevention (CDC). NeoPlex COVID-19 is designed to meet both criteria to fulfill the requirements of all the countries.
The existing COVID-19 testing kits had to use two or three tubes. However, NeoPlex COVID-19 uses only one. Also, Genematrix enhanced correctness and solved concerns for false-positive reactions by verifying zero cross-reaction with 50 different infectious respiratory pathogens.
"Genematrix makes a million tests per month possible and is preparing for a quick production increase if demand soars," a Genematrix official said. "We can start selling overseas in response to the increased demand for diagnostic kits due to the global COVID-19 spread."
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