Kim Forest Enterprise Co Ltd (金萬林) yesterday said that it plans to apply to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) for a COVID-19 testing kit that it developed this month.
Given that the FDA has been issuing such authorizations to expand the pool of available testing resources in the US, it expects to obtain approval, the company said in a statement.
From last month to Tuesday, the US regulator issued 16 EUAs for as many diagnostic devices, according to its Web site.
“Our diagnostic kits are not rapid-screening, but they would be able to provide the results within 50 minutes, compared with a range of three to four hours for existing tests, as we streamlined the test procedure,” a Kim Forest communication official surnamed Wu (吳) said by telephone.
The test kits, which integrate machine and reagents, would limit medical personnel’s risk of exposure to the virus, she said.
As the coronavirus mutates and shows separate properties in different regions, the test kits are designed to identify the different virus strains in Europe, the US and Asia, which would reduce the possibility of producing a false negative result, Wu said.
The company’s marketing partner, US-based Arbelos Genomics Inc, would help submit the application to the FDA, and distribute the test kits to clinics and labs in California if they are approved.
The New Taipei-based company plans to manufacture 6,000 kits in the initial batch, which could be used to test 288,000 people, it said.
The company declined to reveal its revenue projection for the deal, saying that it still needs to negotiate with its US partner.
Kim Forest hopes to market the test kits in Taiwan, but as the government does not allow commercial labs or private clinics to run COVID-19 tests, the company is not in a hurry to apply for marketing approval, Wu said.
“We will adjust our strategy based on the virus situation. So far, the number of infected cases has been rising slowly in Taiwan,” she said.
Taiwan Transport and Storage Corp (TTS, 台灣通運倉儲) yesterday unveiled its first electric tractor unit — manufactured by Volvo Trucks — in a ceremony in Taipei, and said the unit would soon be used to transport cement produced by Taiwan Cement Corp (TCC, 台灣水泥). Both TTS and TCC belong to TCC International Holdings Ltd (台泥國際集團). With the electric tractor unit, the Taipei-based cement firm would become the first in Taiwan to use electric vehicles to transport construction materials. TTS chairman Koo Kung-yi (辜公怡), Volvo Trucks vice president of sales and marketing Johan Selven, TCC president Roman Cheng (程耀輝) and Taikoo Motors Group
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