Filipino-made COVID 19 testing kit is now FDA approved

The Food and Drug Administration (FDA) issued a Certificate of Exemption for the SARS CoV-2 PCR Detection Kit according to their press release earlier today. The said project is funded by the Department of Science and Technology (DOST-Philippines) 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). 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.

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. So, cost of each test is PhP1,120+200 = PhP1,320. Current costing from foreign counterpart is PhP8,500.

Around 200 kits can be manufactured in a week. Limiting factor will be supply of raw materials but they have enough in stock for 6,000 tests now and they ordered last week for 20,000 tests. Expected arrival date is two weeks. They have not manufactured in full because of some uncertainties with the Department of Health, but they already started today upon receiving the FDA certificate. They will deploy 1,000 tests this week by Friday, then 2,000 next week and 3,000 the week after.