FDA OKs imported test kits for commercial release

MANILA, Philippines —  The Food and Drug Administration (FDA) has approved four imported test kits for commercial release amid the coronavirus disease 2019 (COVID-19) outbreak.

“These are PCR-based reagent kits used in laboratories and not point-of care or do-it-yourself kits,” FDA director general Eric Domingo stressed, noting that the distributing companies have all complied with the requirements of the agency.

Aside from those initially approved kits, Domingo said there are other pending applications that are due for evaluation.

In the list of approved test kits are Nucleic acid detection kit for 2019 NCOV manufactured by Shanghai Genoe Dx Co. in China, Novel Coronavirus 2019-ncov nucelic acid detection kit manufactured by Beijing Applied biological Technologies Co. Ltd. The two products are distributed by S&S Enterprise and Sahar International, respectively.

Allplex TM 2019-nCoV Assay manufactured by Seegene Inc. in Seoul, Korea and SOLGENT DialPlex Qtm Novel Coronavirus (2019-nCoV) detection kit manufactured by Solgent Co. Ltd. in Korea were also approved for commercial use.

“FDA is hard at work in processing COVID-19 related applications during this time. We ask the public and stakeholders to be analytical of COVID-19 test kits that they may encounter as we have identified some applications which appear to be suspicious and unauthorized,” Domingo said.

“During this period of emergency, safety is still of utmost priority. We need to be vigilant of the entry of counterfeit products and be watchful of those who try to take advantage of the current situation,” he added – With Pia Lee-Brago, Robertzon Ramirez, Mary Grace Padin, Ric Sapnu