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Taiwan FDA authorizes PCR test kit production by Terry Gou-backed company

Home-use PCR kit, machine developed by iCare Diagnostics receives EUA

(iCare Diagnostics International image)

(iCare Diagnostics International image)

TAIPEI (Taiwan News) — The Food and Drug Administration (FDA) on Friday (May 20) issued emergency use authorization (EUA) for a home-use PCR testing kit developed by a Terry Gou- (郭台銘) backed biotechnology company.

According to iCare Diagnostics International, the “iCare Dx SARS-CoV-2 At-Home Nucleic Acid Test Kit (Nasal)” must be used with the “iCare Dx Nucleic Acid Analysis Machine.” The machine is the first of its kind developed in Taiwan and uses real-time RT-PCR technology to detect the presence of the COVID-19 virus in the nose.

CNA cited the FDA as saying the products have an 85.3% accuracy rate for positive results and a 100% accuracy rate for negative results. As they are designed for home use, pharmacies are authorized to sell them, though prices have yet to be announced.

Terry Gou personally invested in iCare Diagnostics International, per the Liberty Times. The EUA for the manufacture and sale of iCare Dx PCR testing equipment will remain valid until the Central Epidemic Command Center is dismissed.