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World's First COVID-19 Rapid Test Chip Receives Emergency Use Authorization; Molsentech, Academia Sinica, NARLabs, and KSVGH Create Milestone for Epidemic Prevention Devices in Taiwan

The biomedical industry is one of the key forces in Taiwan's effort towards globalization. Therefore, the Ministry of Science and Technology (MOST) is committed to promoting research related to precision health and biomedical technology and facilitating its industrialization for the benefit of society. Since spread of the novel coronavirus (COVID-19) has been rampant, countries across the globe have been doing their utmost to promote the development of testing technology and vaccines. Therefore, Silicon Based Molecular Sensoring Technology CO., LTD. (Molsentech), Academia Sinica, NARLabs' Taiwan Instrument Research Institute (TIRI) under MOST, and Kaohsiung Veterans General Hospital (KSVGH) have collaborated to develop the world's first "COVID-19 Rapid Test Chip," which can quickly and accurately detect very low levels of the virus in patients at the early stages of infection or in asymptomatic COVID-19 patients, all in under 20 minutes. The product has completed validation through clinical tests on 142 cases at KSVGH through a grant from MOST's Innovative Technology and Epidemic Prevention On-site Validation Program, and is expected to be available for sale in February 2022 after obtaining an Emergency Use Authorization (EUA) from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare at the end of 2021.

Molsentech used the Bio-FET platform, developed by a team at the Quantum Electronics Laboratory at Academia Sinica's Institute of Physics, and combined it with its own next-generation testing technology and processing to create the chip, which has since been patented in Taiwan and the United States. In the process of productization, NARLabs' TIRI assisted in safety verification. Then, with the support of MOST's Innovative Technology and Epidemic Prevention On-site Validation Program, KSVGH completed preliminary experiments and clinical validation through 142 case analyses, and the highly sensitive and accurate COVID-19 Rapid Test Chip was finally authorized for emergency use at the end of last year.

With high accuracy of nucleic acid detection and high sensitivity without requiring the amplification of nucleic acid, the COVID-19 Rapid Test Chip can significantly reduce the time required for current nucleic acid tests, enabling patients in the early stages of infection or with no symptoms to obtain accurate test results within 20 minutes through saliva, nasopharyngeal swab, or throat swab. With an accuracy rate of over 95%, the test can help patients learn when to quarantine or get treated early to avoid community infection. Currently, the product is under preparation for EUA application in the U.S. and Japan, with hopes that in the future it can be sold all over the world for the benefit of mankind.

Sales preparation and successful acquisition of the EUA for the COVID-19 Rapid Test Chip can also be credited to TIRI's "Medical Material Accelerator." In addition to actively guiding start-up companies to clear technical, validation, regulatory, and clinical hurdles, TIRI also assisted start-ups in joining the ranks of epidemic prevention, uniting against the pandemic, and grasping practical disease prevention needs in the field. In this way, they have jointly accelerated the development of technological products for epidemic prevention and also have shown significant breakthroughs in new domestic medical devices.