FDA Issues Certificate of Exemption for SARS CoV-2 PCR Kit

With the ongoing threat of COVID-19 in the Philippines, the Food and
Drug Administration issued a certificate of exemption for the SARS CoV-2
PCR detection kit.

Developed by local scientists, the kit will be used for field testing
coupled with gene sequencing at the Philippine Genome Center. The
project is funded by the Department of Science and Technology (DOST).

“The increasing number of reported COVID 19 cases will require immediate
diagnosis and monitoring. This will provide our laboratories with
technological reinforcement to accommodate the growing number of
patients to be tested and aid in early screening of positive cases.
Furthermore, this will provide greater access to a less costly
diagnostic procedure.” DG Domingo said.

The project also supports the CODE RED status raised by DOH.(MLC)