After three weeks of stringent field testing and validation, the low-cost testing kit developed by Philippine Genome Center (PGC) deputy executive director Dr. Raul Destura and his team of University of Philippines (UP) scientists finally gets the approval for commercial use from the Food and Drug Administration (FDA) in the Philippines.
Manila HealthTek, Inc.’s GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection Kit is the first locally made PCR based COVID-19 test kit approved by the FDA. It was developed in collaboration with the University of the Philippines-National Institute of Health (UP-NIH) and funded by the Department of Science and Technology (DOST).
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“The test kit was previously approved by the FDA for field trial with gene sequencing on 10 March 2020. Upon the company’s submission of necessary requirements today, the FDA issued a certification for this COVID-19 test kit to be allowed for commercial use,” reads the advisory released yesterday April 3, signed by FDA director general Dr. Rolando Enrique Domingo.
UP president Danilo Concepcion says the testing kit will help a great deal in helping our country combat the COVID-19 virus. “I believe the approval by FDA of the UP developed test kit is a game changer! Widespread testing will accurately tell us the extent of the problem and how to effectively deal with it,” he declares.
UP Diliman chancellor Fidel Nemenzo remarks that the approval of the COVID-19 testing kits comes at a time when these are most needed. “Our fight against the virus needs to be based on science, social solidarity, and a clearer view of the extent of the infection. We cannot do this without mass testing,” he stresses. “This pandemic, which has disrupted global supply chains, has also underscored the need for developing local industries and capabilities.” Nemenzo likewise lauds Dr. Destura and his team of UP scientists, who have shown that, “with government and public support, Filipinos can produce the necessary technologies to address society's needs.”
Prof. Cynthia P. Palmes-Saloma, PhD, PGC’s executive director, affirms saying that the Philippine FDA’s issuance of the CPR to the GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection Kit “is a welcome and timely development that would enable our locally-manufactured SARS-CoV-2 test kits to be used for our countrymen who are in dire need of these kits. With the availability of our UP-developed kits that are much cheaper than other test kits, we hope that we can help our frontliners, local government units, and the DOH have a better grasp of the extent of SARS-CoV-2 infection in our country.”
She also says that the FDA approval is a validation of the contribution of our local scientists and health professionals to offer science-based solutions to this COVID-19 health emergency that we are facing right now.
The molecular biology and biotechnology professor admits that the approval process for the commercial use of the locally developed COVID-19 detection kit in the Philippines was not easy, so they are deeply thankful to the DOST, the UP administration, and the kind donors of food and personal protective equipment (PPE), for all the help they had extended to the validation team.
It took a village to complete the field testing. The PGC, worked with teams from the UP-NIH, the laboratories of The Medical City (TMC) and other hospitals, in carrying out the field testing.
PGC had two teams working round the clock for more than three weeks—first, testing and refining the protocols, and then doing the analysis during the field validation part. The first team (composed of about 10 molecular biologists, biochemists, medical technologists) did the DNA sequencing, while the other team (composed of eight molecular biology and biotechnology graduates, computer scientists and physicists) took charge of the bioinformatics analysis.
The COVID-19 test kit will be sold commercially by Manila HealthTek at around P1,300 per kit, which is cheaper than the units currently being used in hospitals which cost about P8,000.
Aside from this PCR based test kit, the FDA approved one additional rapid test kit yesterday, which brings the total number of COVID-19 approved test kits to 30. The FDA will continue to update the public on COVID-19 testing kits approval.