The Food and Drug Administration (FDA) has approved COVID-19 testing kits developed by scientists from the University of the Philippines-National Institutes of Health (UP-NIH). The GenAmplify Corona Virus Disease-2019 rRT-PCR Detection Kit is locally made, manufactured by Manila HealthTek, Inc. and funded by the Department of Science and Technology.
In their statement, the FDA said: “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 (April 3), the FDA issued a certification for this COVID-19 test kit to be allowed for commercial use.”
So far, the FDA has approved 21 PCR-based test kits and 9 rapid antibody test kits.
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