The Food and Drug Administration (FDA) approved the use of the coronavirus disease testing kit developed by the University of the Philippines – National Institute of Health (UPNIH) last March 10, 2020.
After being issued a Certificate of Exemption from the FDA, the UP-developed test kit can now be used for field testing coupled with gene sequencing at the Philippine Genome Center.
The FDA Director General Eric Domingo said in a statement that with the increasing number of reported COVID-19 cases in the country, it will require immediate diagnosis and monitoring. Now, with the locally developed test kit, it will provide their laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in the early screening of positive cases.
DG Domingo added that FDA will maintain its mandate in ensuring the safety and efficacy of products and devices to protect the health and commits to cooperate with all agencies in ensuring a prompt response to the global coronavirus disease crisis.