FDA approves commercial sale of COVID-19 test kits from S. Korea, China

Kristine Sabillo, ABS-CBN News

Posted at Mar 19 2020 04:59 PM

MANILA — The Philippines’ Food and Drug Administration (FDA) on Thursday announced it has approved the sale of COVID-19 test kits from South Korea and China.

“These are PCR based reagent kits used in laboratories and not point-of care or do-it-yourself kits,” the FDA said in a statement.

“The companies have complied with the requirements as stated in the FDA Memorandum No. 2020006 entitled, ‘Issuance of Special Certification for Imported Test Kits of COVID-19.’”

PCR refers to polymerase chain reaction, a technology used to identify if a patient's sample has the COVID-19 virus.

The approved products are:

— Nucleic acid detection kit for 2019 ncov, manufactured by Shanghai GenoeDx Biotech Co. and distributed by S&S Enterprise

— Novel coronavirus 2019-ncov nucleic acid detection kit (fluorescence PCR method), manufactured by Beijing Applied Biological Technologies Co. Ltd. and distributed by Sahar International

— AllplexTM 2019-nCoV Assay, manufactured by Seegene Inc. from Seoul and distributed by Endure Medical Inc.

— SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit by Solgent Co. Ltd. from Daejeon, South Korea and distributed by Wellness Pro Incorporated

In a phone interview with ABS-CBN News, FDA Director General Eric Domingo said the approval means the kits can be imported and sold in the Philippines.

He said local hospitals and donors can purchase the kits.

Domingo said the products already have product registration from their FDA counterparts in their country. He said it only takes one to two days to have a test kit certified as long as the company presents complete documents to the FDA.

"There are still pending applications that are due for evaluation. The list shall be regularly updated,” Domingo said.

He warned the public 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.”

“During this period of emergency, safety is still our 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 said.

The Department of Health earlier said it is waiting for test kits from South Korea and China as the country’s number of COVID-19 cases continue to increase.

Filipino scientists are also field testing locally-made test kits. Once approved by the FDA, it can be sold locally. These are reportedly cheaper than imported test kits.

As of Thursday, there are 217 confirmed COVID-19 cases in the Philippines. Of that number, 17 have died and 8 have recovered.

There are a total of 207,000 COVID-19 cases worldwide, according to the World Health Organization. Of this number, more than 8,000 patients have died. However, the number of recovered cases is much higher at 84,000, according to the Johns Hopkins University dashboard.