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.
NOT ALL GOOD: Analysts warned that other data for last month might be less rosy due to the virus and analysts expect the PMI to contract again next month Chinese factory activity saw surprise growth last month as businesses went back to work following a lengthy shutdown, but analysts said that the economy faces a challenging recovery as external demand has been devastated by the COVID-19 pandemic, while the World Bank said that growth could screech to a halt. China is slowly returning to life after months of tough restrictions aimed at containing the virus, which put millions of people into virtual house arrest and brought economic activity to a near standstill. The strict measures saw a closely watched gauge of manufacturing plunge to its lowest level on record in February,
The output of the global smartphone industry this year is to contract by 7.8 percent on an annual basis as the COVID-19 pandemic ushers in a global recession, Taipei-based market researcher TrendForce Corp (集邦科技) said in a report on Monday. The global production of smartphones is expected to fall to 1.29 billion units, as the pandemic dampens demand for consumer electronics, leading to a decline in shipments across Europe and North America, TrendForce said. With consumers delaying smartphone purchases and thereby lengthening the device replacement cycle, overall prices would suffer a setback that is expected to negatively affect the profitability of smartphone
ELECTRONICS Lite-On delays sale of unit Lite-On Technology Corp (光寶科技) yesterday said it would postpone the sale of its solid-state drives (SSD) business to Kioxia Holdings Corp, formerly known as Toshiba Memory Holdings Corp, due to disruptions amid the COVID-19 pandemic. Last year, the Taiwan-based electronics components supplier struck the deal with the Japanese firm, agreeing to sell the unit for US$165 million. Citing unfinished integration work due to the pandemic, Lite-On has deferred today’s closing date until further notice, adding that the delay would not have a negative effect on the unit’s operations. AUTO PARTS Hiroca approves dividend Automotive interior parts supplier Hiroca
ALL ABOUT STRATEGY: The company is optimistic, saying that its gross margin should increase year-on-year, but it is scaling back on its plans to expand capacity Quang Viet Enterprise Co (QVE, 廣越), which makes down jackets and garments for sportswear and outdoor brands including Adidas AG, yesterday said that revenue might drop 5 to 10 percent annually this year as some customers trimmed orders in response to the COVID-19 pandemic. That would mark its first revenue decline since 2016. Quang Viet posted record-high revenue of NT$16.26 billion (US$537.45 million) last year, up 22 percent from 2018. Down jackets made up 40 percent of it revenue last year. North Face Inc and Patagonia Inc are this year likely to reduce orders by 20 to 30 percent from a