AMSBIO, a Korean in vitro diagnostics (IVD) company, envisions a technology that can diagnose various cancers in less than an hour using human saliva.

The company recently received marketing approval from the Ministry of Food and Drug Safety for its Covid-19 test kit, A+CheQ, that uses saliva samples instead of nasal swabs. This company is the first in Korea and the second in the world to obtain regulatory authorization for a saliva-based polymerase chain reaction test kit.

The company had previously run pilot tests in conjunction with the Korea Institute of Science and Technology and Yeosu, near Seoul, which had garnered favorable reviews for its speedy and convenient testing.

Park Hye-rin, chairman of Biosmart Group, the parent of AMSBIO, believes that the approval of the saliva-based PCR test kit will bring innovation to the IVD market.

“With saliva-based testing officially cleared in Korea, the IVD market will be quickly restructured into non-invasive and multi-diagnostic methods that test multiple diseases simultaneously,” Park told Maeil Business Newspaper in a recent interview.

Park saw the potential of the diagnostic market more than a decade ago and worked on developing related diagnostic devices. After the pandemic hit the world, she developed a saliva-based PCR kit based on her research and development know-how. Saliva PCR is a method of collecting genes and amplifying them by raising the temperature to 95 degrees like regular PCR.

The saliva PCR kit is a method of collecting DNA, raising the temperature to 95 degrees Celsius, and amplifying the DNA through the same number of cycles as the traditional PCR. However, the saliva PCR kit reduces the time required for DNA amplification to 37 minutes per cycle. Therefore, the biggest change for the general public is that they can now undergo a Covid test without the discomfort of a nasal swab and receive the results in 30 minutes to an hour.



Park said the company will launch a kit that can test multiple diseases, including Covid-19, the flu, and respiratory syncytial virus (RSV), this fall. AMSBIO is currently conducting additional certification work for its flu and RSV testing performance. Park emphasizes the importance of creating periodic management models using saliva tests for vulnerable groups such as the elderly or those who are susceptible to diseases.

The number of people infected with RSV, one of the most common respiratory infections, has more than doubled in the past month. It is deadly for infants and young children, raising many social concerns. This July, the company plans to get certification for its test for 12 types of sexually transmitted diseases, which tests are required for employees in the local food and beverage industry.

AMSBIO’s accuracy, which is key for diagnostic tests, was also recognized by the health authorities.

“In the diagnostics market, accuracy is key. In our clinical trials, we achieved 100 percent sensitivity and 100 percent specificity,” Park said. Sensitivity refers to the percentage of infected people testing positive for infection and specificity, the percentage of non-infected people testing negative for infection.

The standard for approval of PCR kits by the MFDS for professional use is at least 95 percent sensitivity and specificity.

Park hopes that the saliva-based PCR test will be widely adopted in hospitals, given its shorter turnaround time.

Traditional PCR tests can take more than half a day to produce results, which means patients have to be isolated in hospital rooms for two days until their results are available. “However, the saliva PCR test can provide results in as little as 30 minutes to an hour, which would be a great help in hospital operations.”

Park’s ultimate goal is to revolutionize the diagnostics market and accelerate the era of preventive medicine. “We have opened the door to non-invasive DNA testing for the diagnosis of various diseases, including cancer. We aim to lead the future precision diagnostics market,” she said.

By Yoo Joo-yeon and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]