UP-developed test kit for Covid-19 gets FDA approval for commercial use

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The Food and Drug Administration (FDA) formally issued on Friday, April 3, its approval for the commercial use of the Covid-19 detection kit developed by UP researchers led by Dr. Raul Destura.

The license for GenAmplify test kit, which will be commercially manufactured by Manila HealthTek, Inc. was released three days after the completion of its field validation study last April 1, 2020. 

The test kit is the first locally manufactured test kit for Covid-19 and was developed in collaboration with the Philippine Genome Center (PGC) and the University of the Philippines – National Institutes of Health (UP-NIH) with support from the Department of Science and Technology – Philippine Council for Health Research and Development (DOST-PCHRD). 

The approval issued by the FDA signals the start of its roll-out to several hospitals in and out of Metro Manila starting on April 4. 

Destura and his team are currently working on the production of 120,000 tests — 26,000 of which will be distributed by the DOST to the Philippine General Hospital, 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.

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 (PCR) platform, each test is projected to cost P1,320 which is significantly cheaper than its foreign counterparts. 

In the press briefing held for the test kit last March 12, DOST secretary Fortunato T. de la Peña cited the project as an example of solutions brought by R&D that help the country achieve its national goals and address emergencies or crises.

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