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Manila Bulletin devider Philippines devider National devider Locally-made COVID-19 test kits get FDA green light

Locally-made COVID-19 test kits get FDA green light

Published Jul 4, 2020 10:35 am

A locally-developed test kit for the detection of the coronavirus disease (COVID-19) has been given the green light by the Food and Drug Administration (FDA), Department of Science and Technology (DOST) Secretary Fortunato de la Pena announced on Friday, July 3.

Department of Science and Technology Secretary Fortunato dela Peña (TOTO LOZANO/ Presidential Photo / MANILA BULLETIN FILE PHOTO)

In his weekly report, Dela Peña said the second version of the GenAmplify COVID-19 test kit “passed the confirmatory testing conducted by the RITM (Research Institute for Tropical Medicine) and the Committee on Laboratory Expert Panel.”

The DOST secretary said the test kit was developed by the DOST’s Philippine Council for Health Research and Development (DOST-PCHRD).

“With the endorsement of RITM, the Food and Drug Administration (FDA) has released a certification on the validity and reliability of the kit,” he said.

“Distribution of new kits under the project to selected recipient hospitals and testing centers will be continued,” he added.

Dela Peña also announced that the University of the Philippines-Philippine General Hospital (UP-PGH) also officially started last Wednesday, July 1, its “study to determine whether convalescent plasma transfusion may be beneficial in the treatment of COVID-19.”

Dela Peña said the project is being supported also by the DOST-PCHRD.

“This is a one year project involving a funding of a P4.99 million,” he revealed.

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