FDA allows the use of COVID-19 Test Kits developed by Filipino scientists

The Department of Health (DOH) recently raised CODE RED status in the Philippines while President Rodrigo Duterte declared a state of Public Health Emergency.

In line with this, a Certificate of Exemption for the SARS CoV-2 PCR Detection Kit has been issued by the Food and Drug Administration (FDA) today. This locally developed COVID-19 test kits will be used for field testing coupled with gene sequencing at the Philippine Genome Center.

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FDA PRESS RELEASE March 9, 2020

The University of the Philippines- National Institute of Health (UP­ NIH) technology is funded by the Department of Science and Technology (DOST).

Here is Director General Rolando Enrique Domingo’s statement in the press release issued today by the FDA…

“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.”

“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.”

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