[Our Stories]SML Genetree’s COVID-19 Diagnostic Kits receive official approval from South Korea’s Ministry of Food and Drug Safety and FDA approval from the Philippines

SML Genetree, a molecular diagnostic company, announced that the Ezplex® SARS-CoV-2 G Real-Time PCR COVID-19 diagnostic kit was officially approved by the Ministry of Food and Drug Safety (MFDS) of South Korea.

In January 2021, SML Genetree received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Ezplex® SARS-CoV-2 G Kit that includes specimen pooling capability.

As a third wave of COVID-19 infections is currently underway in South Korea, SML Genetree company officials explained that if the benefits of the Ezplex® SARS-CoV-2 G Kit are fully utilized, the cost and time of medical staff and examination agencies can be reduced significantly.

In addition, another COVID-19 diagnostic kit from SML Genetree, the Ezplex® SARS-CoV-2 FAST G Kit, received FDA approval in the Philippines. The Ezplex® SARS-CoV-2 FAST G Kit has a faster PCR reaction time of around 35 minutes post nucleic acid extraction. It has already received Emergency Use Authorization from MDFS for emergency screening purposes in June 2020.

Currently, the cumulative number of confirmed COVID-19 cases in the Philippines is over 523,000, and the daily number of confirmed cases is around 2,100. With the continued spread of COVID-19, the approval for use of the Ezplex® SARS-CoV-2 FAST G Kit is expected to enable more rapid testing and contribute to reductions in the spread of the virus in the Philippines.