FDA Allows Use of COVID 19 Test Kits Developed by Local Scientists

March 9, 2020

FDA PRESS RELEASE

FDA ALLOWS USE OF COVID 19 TEST KITS DEVELOPED BY LOCAL SCIENTISTS

The Food and Drug Administration (FDA) today issued a Certificate of Exemption for the SARS CoV-2 PCR Detection Kit. This University of the Philippines-National Institute of Health (UP-NIH) technology, developed by local scientists, is 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.

"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." DG Domingo said.

"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." DG Domingo concluded.