Han-oh Park, CEO of Bioneer, "Developed COVID-19 PCR Diagnostic Equipment in 30 Minutes... To Be Released Within the Year"

Korea and Europe Certification Pursued This Year, US Next Year
"Same-Day Diagnosis Results Available at Local Clinics"

Han-oh Park, CEO of Bioneer, is holding a press conference on the 24th in Jongno, Seoul, announcing plans to develop rapid molecular diagnostic equipment (IRON-qPCR). (Photo by Bioneer)

[Asia Economy Reporter Kim Ji-hee] Bioneer, a molecular diagnostics specialist company, will launch a rapid gene amplification (PCR) molecular diagnostic device within the year that can identify 20 types of respiratory diseases, including COVID-19, in just 30 minutes. While maintaining diagnostic accuracy, it has reduced the time required to determine infection status to less than a quarter compared to existing devices, and it is a product that can be easily tested even at local clinics.

Han-oh Park, CEO of Bioneer, held a press conference on the 24th in Jongno, Seoul, to announce plans for the development of the next-generation rapid molecular diagnostic device (IRON-qPCR). CEO Park said, "The most effective way to prevent infectious diseases from spreading into a pandemic is rapid diagnosis and isolation," adding, "The ultimate goal is to distribute this device to all local clinics and public health centers."

The IRON-qPCR, which Bioneer is developing with a target release in September, is compact and easy to use in hospital emergency rooms or public health centers. While existing molecular diagnostic devices take about 2 to 2.5 hours to confirm infection, IRON-qPCR can do so in 30 minutes. By injecting samples collected with a swab from the saliva or nose of the test subject and operating the device, results are quickly obtained. It can test samples from two people simultaneously. CEO Park emphasized, "We plan to obtain approval from the Ministry of Food and Drug Safety and European certification (CE) within this year, and pursue approval from the U.S. Food and Drug Administration (FDA) next year."

Although COVID-19 vaccination is accelerating, CEO Park explained that the COVID-19 diagnostic market will continue to grow next year. He said, "Even with COVID-19, variant viruses that increasingly reduce the effectiveness of vaccines are emerging, which essentially become new viruses," adding, "I believe that the next-generation device currently under development, once distributed worldwide, will enable faster and more rapid diagnosis on-site, preventing second and third pandemics."

Bioneer is also developing 'symptom-based multiplex diagnostic kits' for IRON-qPCR. These kits can simultaneously test which of up to 40 causative pathogens the patient is infected with. Equipped with such devices and kits, local clinics will be able to identify pathogens on the day of consultation without sending samples to outsourced testing institutions, allowing immediate treatment. CEO Park said, "When gathering all pathogens that could be possible for symptom-based diagnosis, the number does not exceed 40," adding, "Even if new variants emerge and the number reaches 20, testing will still be possible. Special attention should be paid to variants with high mortality rates or those that reduce vaccine effectiveness."

Additionally, Bioneer will launch a high-capacity fully automated molecular diagnostic system (ExiStation 96/384 FA) within the year to target large testing centers with high volumes of COVID-19 tests and advanced country markets. Like IRON-qPCR, it has the advantage of speed. It can process 96 or 384 samples simultaneously, completing sample dispensing, nucleic acid extraction, amplification, and diagnosis within 90 minutes. This significantly reduces the time compared to existing high-capacity devices, which took up to 4 hours.

This content was produced with the assistance of AI translation services.