The first Philippine-made COVID-19 Rapid Diagnostic Test Kit developed by the University of the Philippines National Institutes of Health (UP NIH) and financed by the Department of Science and Technology (DOST) has been certified by the Food and Drug Administration (FDA) for commercial release beginning today.
The FDA Certification of Product Registration (CPR) for the GenAmplify Coronavirus Disease 2019 (COVID-19) Real-Time-PCR Detection Kits was released on Friday, April 3, 2020, and announced in the FDA Advisory No. 2020-513.
The Philippine COVID-19 test kit was earlier approved for the field trial with gene sequencing at the Philippine Genome Center which wrapped up on April 1. FDA announced the awarding of the product registration on the same day the requirements were submitted on Friday.
“This is the first locally made PCR based COVID-19 test kit approved by the FDA,” announced the FDA. The Philippine-made COVID-19 test kit brings the FDA-approved test kits to a total of 30.
DOST Secretary Fortunato de la Peña announced the good news in light of the projected mass testing in the Philippines that begins on April 14.
“This is great news as the country aims to conduct mass testing of suspected COVID-19 cases starting on April 14. The mass testing will prioritize persons under investigation (PUIs) and persons under monitoring (PUMs), according to the Department of Health (DOH),” said Secretary de la Peña.
Manila HealthTek is reportedly all ready for mass production after having received the first batch of reagents that will be used to start manufacturing the test kits that can accommodate up to 120,000 tests.
The GenAmplify Coronavirus Disease 2019 (COVID-19) Real-Time-PCR Detection Kits can only be used in hospitals with Polymerase Chain Reaction (PCR)-based machines, also known as thermocyclers/DNA amplifiers to work and cannot be used at home.
DOST announced that the COVID-19 test kits good for 26,000 tests will be distributed to the following hospitals:
- Philippine General Hospital
- Makati Medical Center
- The Medical City
- Vicente Sotto Memorial Medical Center
- Southern Philippines Medical Center
- Baguio General Hospital
Part of the first batch of the GenAmplify test kits will be used in the field implementation that will be conducted from April 4 to 25.
Another set of testing kits good for 94,000 tests will be sold commercially by Manila HealthTek at around Php 1,300 per kit which is cheaper than the units currently being used in hospitals which cost about Php 8,000.
The Manila HealthTek said they have enough orders from the private sector who intend to donate them in turn to the DOH and hospitals.
The GenAmplify COVID-19 Test Kit was developed at the UP NIH by a team of Filipino scientists led by Dr. Raul Destura, who had previously developed the Lab-In-a-Mug Dengue Rapid Diagnostic Test Kit.
SEND CHEERS in the comments below to the UP NIH, Manila HealthTek, DOST, and the teams behind the development and validation of the Philippine-developed GenAmplify COVID-19 Test Kits!
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