Locally developed COVID-19 test kit gets FDA go-ahead

MANILA, Philippines — Four months after its rollout, the locally developed test kit for the new coronavirus that causes COVID-19 can finally be used, having met the “stringent safety requirements” of the Food and Drug Administration (FDA).

In a statement late Saturday, Dr. Raul Destura, one of the proponents, said the second version of the GenAmplify COVID-19 RT-PCR (reverse transcription-polymerase chain reaction) kit was finally “available commercially” following “several months of working to comply with the stringent safety requirements” set by the FDA.

“Our team has always been focused on developing an accurate, safe and affordable test kit that will benefit the most number of Filipinos so that we can beat the COVID-19 epidemic,” Destura said.

“Since the start of the COVID-19 epidemic, we have been working hand-in-hand with FDA, the Department of Health and [the] Research Institute for Tropical Medicine (RITM) to comply with all their requirements, and we will continue to do so,” he added.

DOH go-signal

Earlier, Health Undersecretary Maria Rosario Vergeire said the University of the Philippines National Institutes of Health recalled all its test kits in order to correct the flaws found by RITM during its validation of the locally developed kits.

After Manila HealthTek, which manufactures the kit, corrected the undisclosed defects, Vergeire said the DOH gave the go-signal for its use, provided laboratory personnel were trained on how to use it.

“They have to undergo this training because it’s a new kit and they need to have a proficiency test for that,” she said.

On Saturday, opposition senators—Franklin Drilon, Francis Pangilinan and Risa Hontiveros—called on Health Secretary Francisco Duque III to allow the use of the UP test kits to help generate savings for the government.

On Sunday, Sen. Christopher “Bong” Go, head of the Senate health committee, joined the minority bloc and urged the DOH to use the locally made test kits.

“I appeal to the concerned agencies not to waste the time and effort placed on the development of these available testing kits by our local scientists,” Go said in a Viber message to the Inquirer.

At P1,320, the UP test kit is much cheaper than its foreign counterparts. Foreign-made kits cost around P8,000.

—With a report from Marlon Ramos