FDA approves first locally-made COVID-19 test kit

The Food and Drug Administration (FDA) has approved for commercial use the first locally manufactured COVID-19 testing kit, the GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection Kit, developed by University of the Philippines (UP) scientists.

Manila HealthTek, Inc. will manufacture 120,000 test kits, with 26,000 to be distributed by the Department of Science and Technology (DOST) and UP-NIH to select public hospitals for field implementation.

The UP-developed test kits are capable of fast detection of coronavirus, with results ready in two hours.

The remaining 94,000 test kits will be sold commercially at approximately P1,300 per kit, significantly cheaper than foreign counterparts.

DOST Secretary Fortunato dela Peña stated that this development is crucial for the country's mass testing efforts, which will prioritize persons under investigation (PUIs) and persons under monitoring (PUMs) starting April 14.

Senator Joel Villanueva lauded the FDA's approval, stating that the locally-developed kits will help the government save lives and expand testing capabilities.

Villanueva highlighted the importance of supporting research initiatives of state universities and colleges, citing the test kits as a tangible result of investment in higher education institutions.