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FDA OKs use of UP-developed COVID-19 test kits


The Food and Drug Administration (FDA) has allowed the use of locally-developed test kits for the detection of novel coronavirus as confirmed cases of the deadly disease continue to mount.

The Philippines has 24 confirmed cases of coronavirus disease 2019 (COVID-19) as of Tuesday morning.

The FDA issued on Tuesday Certificate of Exemption for the SARS CoV-2 PCR detection kit. The test kit was developed by local scientists at the University of the Philippines-National Institute of Health (UP­NIH), funded by the Department of Science and Technology (DOST). 

The kit will be used for field testing coupled with gene sequencing at the Philippine Genome Center.

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, according to the FDA.

On Sunday, Duterte signed Proclamation 922 declaring a public health emergency over the increasing number of COVID-19 cases in the country. 

Health Secretary Francisco Duque III earlier said the DOH had recommended the declaration after it raised its alert to Code Red Sub-Level 1 as it confirmed that the fifth COVID-19 patient was a case of local transmission. 

"The increasing number of reported COVID 19 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. Furthermore, this will provide greater access to a less costly diagnostic procedure," said Health Undersecretary Eric Domingo, the FDA director general.

"The FDA maintains its mandate in ensuring the safety and efficacy of products and devices to protect public health, and commits to cooperate with all agencies in ensuring a prompt response to this global crisis," he added. —Ted Cordero/KBK, GMA News

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