FDA issues Exemption Certificate for local SARS CoV-2 PCR Detection Kit

Harnessing the ingenuity of Filipino scientist and doctors with the full backing of the DOST, Dr. Raul Destura and his team were able to create the Lab-in-a-Mug device.
(Photo from the Philippine Genome Center).

The Food and Drug Administration (FDA) has issued a Certificate of Exemption for the locally developed and manufactured SARS CoV-2 PCR Detection Kit that will make it much cheaper for Filipino health professionals to test for the coronavirus.

The project is funded by the Department of Science and Technology (DOST) through the Philippine Council for Health Research and Development (DOST-PCHRD).

The SARS CoV-2 PCR Detection Kit technology is developed by local scientists led by Dr. Raul V. Destura from the University of the Philippines-National Institute of Health (UP-NIH). 

Dr. Raul V. Destura

The kit will be used for field testing coupled with gene sequencing at the Philippine Genome Center. The DOST also helped Dr. Destura in forming his spin-off company Manila Health Tek and will make available test kits at a fraction of the cost of imported text  kits.

The COVID-19 kit costs PhP28,000 per 25 tests and the RNA extraction kit costs PhP10,000 per 50 reactions. The RNA extraction kit is for extracting the virus from the specimen. 

The cost for each test is P1,120+200 = P1,320 or only 16 percent of the current cost of imported test kits at P8,500.

Researchers at the Research Institute of Tropical Medicine prepare to load reagents into a real-time PCR machine as they check their testing kits for the Zika virus. RITM

Around 200 kits can be manufactured in a week but is currently limited by the supply of raw materials. The present inventory is enough for 6,000 tests with another 20,000 on order and expected to be delivered in two weeks.

Manila Health Trek has not yet maximized its production capacity because of some uncertainties with the Department of Health, but DOST reports it has already started today upon receiving the FDA certificate. The firm will deploy 1,000 tests this week by Friday, another 2,000 next week, to be followed by another 3,000 the week after. #

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