FDA approved Coronavirus Diagnostic Test Kits Made by Philippine University

Food and Drug Administration (FDA) has approved test kids for the latest coronavirus (COVID-19) outbreak, developed by the researchers from the University of the Philippine. In its statement released on March 10^th, the federal agency stated that it has issued the “certificate of exemption” for these coronavirus diagnostic test kits called “Sars-CoV-2 PCR Detection Kits”. The International Committee on Taxonomy of Viruses has given coronavirus a unique name that is “Sars-CoV-2”.

This developmental program was funded by the Department of Science and Technology. In the statement, the FDA wrote; “This supports the Code Red status raised by the Department of Health (DOH) and the recent declaration of President Rodrigo Duterte of a state of Public Health Emergency.”

Earlier this week, President Rodrigo Duterte declared a “public health emergency” against the recent coronavirus outbreak.  The Department of Health (DOH) initially upraised the “Code Red Sublevel 1” when the country reported its first coronavirus positive case.

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FDA’s Director General (DG) Rolando Enrique Domingo says that these coronavirus diagnostic test kits would help to monitor the patients and identify them after they contact the coronavirus. In his statement, President Domingo said;

“The increasing number of cases will require immediate diagnosis and monitoring. This will provide our laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in early screening of positive cases.

He also shared that; “Furthermore, this will provide greater access to a less costly diagnostic procedure. ”

As that of this week, the Philippines have reported 24 confirmed coronavirus cases in the country. It includes first death confirmed on March 9^th, which was a Chinese tourist traveled from Wuhan to the Philippines.

President Domingo also said that FDA would keep on playing its role to mandate and ensure public safety through evaluating the products and devices. He indicates cooperating with all agencies including the FDA to tackle the current coronavirus infection that has become a public health crisis.

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Health Secretary Francisco Duque III previously said that there are not sufficient coronavirus diagnostic test kits for testing coronavirus patients. He also mentioned that the Philippines is working on manufacturing nearly  4,500 test kits and he expects 2,000 more kits to be received from the World Health Organization (WHO). Upon the efficacy of these test kits, the Health Secretary declared that these kits show results within two hours of testing and are so far the only accurate way of diagnosing the virus in suspected people.

The coronavirus is thought to be originated from Wuhan city, Hubei province of China in a local seafood market in December 2019. Within a couple of months, this virus has spread to more than 90 countries, infected 100,000 people worldwide and caused 35,00 plus deaths within and outside China.