FDA approves UP COVID-19 test kits for commercial use

Kristine Sabillo, ABS-CBN News

Posted at Apr 03 2020 08:32 PM | Updated as of Apr 03 2020 08:41 PM

MANILA—The Food and Drug Administration (FDA) has approved the University of the Philippines-developed COVID-19 test kits.

“FDA approved 2 additional kits today,” the agency posted in its website on Friday.

One of the approved kits is Genamplify coronavirus disease-2019 rRT-PCR detection kit.

The kit was developed by scientists from the University of the Philippines National Institutes of Health (UP-NIH) and the Philippine Genome Center with the support of the Department of Science and Technology. It is being manufactured and distributed by Manila Healthtek Inc. 

The FDA advisory signed by director-general Eric Domingo states that the company submitted all requirements on Friday and was immediately granted a certification for commercial use.

The kit was earlier approved by the FDA for field trial with gene sequencing.

It is real-time reverse transcription polymerase chain reaction-based, which is the “gold standard” for COVID-19 testing.

Also approved by the FDA is a a rapid test kit manufactured from China.

There are now 21 PCR-based test kits and 9 rapid test kits approved by the FDA.

Earlier this week, the DOST announced that the kits will be approved Friday, April 3. 

Of the initial batch of 120,000 test kits, 26,000 will be bought by the government and distributed to public laboratories.