FDA approves coronavirus test kits developed by U.P. scientists

MANILA, Philippines – The Food and Drug Administration (FDA) has approved the use of COVID-19 test kits developed by University of the Philippines (UP) scientists.

The FDA said on Tuesday, March 10, that it issued a Certificate of Exemption for the SARS CoV-2 PCR Detection Kit of the University of the Philippines-National Institute of Health (UP-NIH).

The kit, funded by the Department of Science and Technology, will be used for field testing coupled with gene sequencing at the Philippine Genome Center, the FDA said in a statement.

Heath Undersecretary Eric Domingo, FDA chief, said that the use of the locally-developed test kits would help address the "increasing number of reported COVID-19 cases" that "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,” Domingo added.

The FDA said the locally-developed kits supports the Code Red status raised by the Department of Health, and the recent declaration of a state of public health emergency in the country over the threat of COVID-19, the disease caused by the novel coronavirus. 

The FDA approved the use of the test kits more than a month after UP-NIH scientists announced the development of the test kit that would help the DOH confirm more COVID-19 cases in the country. 

The total number of confirmed COVID-19 cases in the Philippines was at 24 as of Monday night, March 9. Of this number, one died – a Chinese tourist who came from Wuhan, China – the first death outside China. – Rappler.com