By PNA * DHEL NAZARIO
The Food and Drug Administration has approved the COVID-19 test kit developed by the University of the Philippines-National Institutes of Health.
“The Food and Drug Administration has now approved the Real-Time PCR for the detection of COVID-19 manufactured by the Manila HealthTek Inc. for commercial use,” the FDA said in an advisory last Friday night.
The FDA had earlier approved the UP-developed test kit for field trial.
Upon the company’s submission of necessary requirements, the FDA issued a certification for the COVID-19 test kit to be allowed for commercial use.
“This is the first locally made PCR-based COVID-19 test kit approved by the FDA which was developed in collaboration with the University of the Philippines-National Institute of Health, funded by the Department of Science and Technology,” the FDA said.
The FDA also approved one additional rapid test kit last Friday –”Hightop SARS-CoV-2 IgM/IgG Antibody” – bringing the total number of COVID-19 approved test kits in the country to 30.
The developers of the test kit led by Dr. Raul Destura and are now working on the production of 120,000 tests.
The DoST will distribute 26,000 of the 120,000 tests to the Philippine General Hospital in Manila, Makati Medical Center, The Medical City in Pasig City, Vicente Sotto Memorial Medical Center in Cebu City, Southern Philippines Medical Center in Davao City, and Baguio General Hospital Medical Center in Baguio City for field implementation from April 4 to April 25. The remaining 94,000 tests will be sold commercially by the Manila HealthTek Inc.
“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 and Persons Under Monitoring, according to the Department of Health,” said DoST Secretary Fortunato dela Peña.
The test kit – GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection Kit – is the first locally manufactured test kit for COVID-19 and was developed in collaboration with the Philippine Genome Center and the University of the Philippines-National Institutes of Health with support from the DoST-Philippine Council for Health Research and Development.
Its approval signals the start of its roll-out to several hospitals in and out of Metro Manila starting on April 4.
The COVID-19 detection kit was developed to provide accessible and affordable testing for the Filipino as a response to the growing worry on the risks posed by the infection towards public health.
By utilizing a one-step multiplex real-time polymerase chain reaction platform, each test is projected to cost P1,320 which is significantly cheaper than its foreign counterparts.
In a press briefing for the test kit last March 12, De la Peña cited the project as an example of solutions brought by research and development that help the country achieve its national goals and address emergencies or crises.
