11 manufacturers of self-administered antigen test kits seek FDA approval –DOH

Eleven manufacturers of self-administered antigen test kits have applied to the Food and Drug Administration (FDA) for approval, the Department of Health (DOH) said Tuesday.

“Meron na pong nag apply sa Food and Drug Administration ng mga home administered kits. Ito po ay mga manufacturers, 11 na po ang nakapag apply,” Health Undersecretary Maria Roasrio Vergeire said in a media briefing.

(11 manufacturers of home-administered kits had applied for FDA approval.)

Vergeire said the FDA will evaluate the antigen test kits before sending these to the Research Institute for Tropical Medicine for performance validation

This normally takes about two days, according to Vergeire.

“Usually based on the load of work ng RITM, although they were instructed to prioritize this, it will take them about two days no, or 48 hours for them to finish a performance validation for a specific kit,” she said.

Afterward, the antigen test kits will be returned to the FDA.

“Sabihin po natin that within seven to ten days lalabas ang registration o certification nitong mga home administered test kits na napapasa sa standards ng RITM at saka ng FDA,” she said.

(Let’s say that within seven to ten days, the registration or certification of the home administered test kits that passed the standards of the RITM and FDA will be issued.)

Lowering antigen prices

Meanwhile, Vergeire said the DOH is also looking into lowering the prices of antigen tests.

Vergeire said the DOH is coordinating with the Department of Trade and Industry on the matter.

“Ang ginagawa po ngayon ng gobyerno ay para magkaroon ngayon ng price cap. We are now reviewing, meron na tayong naunang price cap for our testing methodologies,” she said.

(The government is trying to put a price cap on antigen kits. We are reviewing the matter. There already is a price cap on our testing methodologies.)

“Ngayon, sinasabi na natin sa pagaaral rin ang antigen test. Magpapalabas po tayo in the coming weeks siguro,” she added.

(Not, we are studying if we can do this with antigen tests. This will be released in the coming weeks.)

Health Secretary Francisco Duque III previously said that the DOH was eyeing to lower RT-PCR prices. — DVM, GMA News