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
China has claimed a breakthrough in developing homegrown chipmaking equipment, an important step in overcoming US sanctions designed to thwart Beijing’s semiconductor goals. State-linked organizations are advised to use a new laser-based immersion lithography machine with a resolution of 65 nanometers or better, the Chinese Ministry of Industry and Information Technology (MIIT) said in an announcement this month. Although the note does not specify the supplier, the spec marks a significant step up from the previous most advanced indigenous equipment — developed by Shanghai Micro Electronics Equipment Group Co (SMEE, 上海微電子) — which stood at about 90 nanometers. MIIT’s claimed advances last
ISSUES: Gogoro has been struggling with ballooning losses and was recently embroiled in alleged subsidy fraud, using Chinese-made components instead of locally made parts Gogoro Inc (睿能創意), the nation’s biggest electric scooter maker, yesterday said that its chairman and CEO Horace Luke (陸學森) has resigned amid chronic losses and probes into the company’s alleged involvement in subsidy fraud. The board of directors nominated Reuntex Group (潤泰集團) general counsel Tamon Tseng (曾夢達) as the company’s new chairman, Gogoro said in a statement. Ruentex is Gogoro’s biggest stakeholder. Gogoro Taiwan general manager Henry Chiang (姜家煒) is to serve as acting CEO during the interim period, the statement said. Luke’s departure came as a bombshell yesterday. As a company founder, he has played a key role in pushing for the
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) has appointed Rose Castanares, executive vice president of TSMC Arizona, as president of the subsidiary, which is responsible for carrying out massive investments by the Taiwanese tech giant in the US state, the company said in a statement yesterday. Castanares will succeed Brian Harrison as president of the Arizona subsidiary on Oct. 1 after the incumbent president steps down from the position with a transfer to the Arizona CEO office to serve as an advisor to TSMC Arizona’s chairman, the statement said. According to TSMC, Harrison is scheduled to retire on Dec. 31. Castanares joined TSMC in
EUROPE ON HOLD: Among a flurry of announcements, Intel said it would postpone new factories in Germany and Poland, but remains committed to its US expansion Intel Corp chief executive officer Pat Gelsinger has landed Amazon.com Inc’s Amazon Web Services (AWS) as a customer for the company’s manufacturing business, potentially bringing work to new plants under construction in the US and boosting his efforts to turn around the embattled chipmaker. Intel and AWS are to coinvest in a custom semiconductor for artificial intelligence computing — what is known as a fabric chip — in a “multiyear, multibillion-dollar framework,” Intel said in a statement on Monday. The work would rely on Intel’s 18A process, an advanced chipmaking technology. Intel shares rose more than 8 percent in late trading after the