Medigen Vaccine Biologics Corp (高端疫苗) has obtained certification to market its COVID-19 reagent, which uses a polymerase chain reaction (PCR) technique, in the eurozone.
“The approval gave us access to the European market, but as our testing kits are produced in Taiwan, we need to gain marketing approval from the Taiwan Food and Drug Administration before exporting those products,” spokesman Leo Lee (李思賢) told the Taipei Times by telephone on Monday.
The crisis could accelerate the agency’s review, compared with at least one year in the past, Lee said.
Given the shortage of coronavirus testing kits, foreign buyers have shown an interest in the firm’s products, he said, adding that Medigen’s local plant has produced some kits.
For an in vitro diagnostic device, the firm spent one month gaining CE marking certification, which is required for products sold in the European Economic Area, under an emergency-use program initiated by the European Commission.
Medigen’s diagnostic reagent was the latest to obtain the certification, after products manufactured by GeneReach Biotechnology Corp (瑞基海洋) and General Biologicals Corp (普生).
Like the other companies’ products, Medigen’s reagent gives results in about 80 minutes, with an accuracy rate of 95 percent, Lee said.
As some people infected with COVID-19 have shown false negatives, the public has questioned the accuracy of the testing kits that are available.
“The false negatives are not the result of a failure on the part of the testing kits, as most medical devices are sensitive and accurate. It is more likely attributable to how the samples are collected,” Lee said.
If the viral load on a throat swab is too low, the result cannot be positive, so it is important to conduct the tests several times, he said.
Medigen is not concerned that competition in the coronavirus reagent business could heat up too much as foreign companies develop antibody testing kits, Lee said, adding that PCR testing kits identify the coronavirus, while the antibody blood tests determine whether a person’s immune system has developed antibodies against the virus.
“The former determines if those tested would infect others, while the latter determines if the person has recovered and can come out of isolation,” Lee said.
The two products are used in a complementary way, he added.
Separately, active pharmaceutical ingredient maker Formosa Laboratories Inc (台耀化學) on Monday said that it collaborated with National Yang-Ming University in Taipei, National Chiao Tung University in Hsinchu and Taipei Veterans General Hospital in synthesizing 168g of remdesivir, a new antiviral drug by US-based Gilead Sciences Inc that targets infectious diseases such as Ebola and SARS, and that has shown some effectiveness against COVID-19.
Formosa Laboratories told local media that it has spent NT$4 million (US$133,174) on capacity to produce remdesivir.
The firm has also funded research on the production of favipiravir, the main ingredient in the influenza drug Avigan, which was developed by Fujifilm Holdings Corp in Japan and is being tested as a potential treatment for COVID-19.
Additional reporting by staff writer
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