Korea’s new PCR kits, devices to speed COVID-19 detection

South Korea’s biotechnology companies are releasing polymerase chain reaction (PCR) kits and equipment to detect COVID-19 infections within an hour, far faster than the usual six hours, changing the landscape of the pandemic diagnosis market.

Genematrix Inc. said on July 14 that its NeoPlex COVID-19 FAST, which provides test results in 40 minutes, received export approval from South Korea’s Ministry of Food and Drug Safety. The company also obtained Conformite Europëenne (CE) marking to sell it in Europe.

The kit allows to detect COVID-19 infections quickly in airports, ports and schools where people gather, the company said. In addition, the product can check various coronavirus variants, including ones from India, the UK, Brazil and South Africa.

The diagnostic kit industry is making every effort to reduce the needed detection time of PCR kits, which are more accurate than antibody and antigen immunodiagnostic kits. PCR testing kits require more time than immunodiagnostic kits because it usually takes about six hours to amplify a gene. The industry is trying to cut this 20-60 minutes.

BIONEER, SD BIOSENSOR TO LAUNCH QUICK TEST DEVICES

Bioneer Corp. plans to launch a diagnostic device that can detect COVID-19 infection within 30 minutes later this year. It will release the equipment and kits for emergency rooms, screening clinics and public health centers by using an amplification device.

SD Biosensor Inc., the world’s top COVID-19 test kit maker, was scheduled to unveil a new PCR device that provides diagnostic results within 60 minutes next month. It aims to preoccupy on-site diagnosis platforms by distributing about 40,000 amplification devices, worth about 100 billion won ($87.2 million), worldwide for free.

The company already sold 700 million units of COVID-19 test kits globally from February 2020 to May this year. Its initial public offering (IPO) earlier this month was oversubscribed by more than 274 times, drawing 31.9 trillion won from retail investors. 

Boditech Med, Inc., strong in immune diagnosis, received approval from Korea's Ministry of Food and Drug Safety for a field-type PCR kit that can simultaneously diagnose three specific genes. The kit can detect variants from the UK and South Africa.

Write to Ju-Hyun Lee at deep@hankyung.com
Jongwoo Cheon edited this article.