Hospital-grade in vitro diagnosis available at home

The Electro-Medical Equipment Research Division at the Korea Electrotechnology Research Institute (KERI, Acting President Dr. Nam Kyun KIM) harnessed the power of advanced biophotonics technologies to build foundations to develop low-cost, compact, high-precision and automated versions of typical in vitro diagnostic devices that are used to be only available at major hospitals, thereby significantly improving citizens’ accessibility to high-quality healthcare services in non-clinical settings.

In vitro tests use blood, urine, tissue, or other specimens collected from the human body to find disease-related biomarkers. Recently in vitro diagnostics has attracted people’s attention as a way to test COVID-19 infections. Other key applications include cardiovascular disease, diabetes mellitus, and cancer. Typically, in vitro diagnostic equipment for serious medical conditions at domestic hospitals relies on costly imports, with a market share of greater than 95%, and is only available at major hospitals and select specialists.

Pursuing the great purpose of “expanding quality healthcare services for all,” the KERI recently developed a non-invasive and cutting-edge biophotonics-embedded in vitro diagnostic system that allows for real-time monitoring of a wide range of chronic diseases at primary clinics and homes.

The key to this system is user convenience enabled by cost reduction, downsizing, high-precision, and intelligent automation. The majority of the element technologies embedded in this system are either KERI technology-oriented or, namely, first-of-its-kind in the world. The research team utilized world-leading high-precision optical technologies such as 2D mini LED array multi-color light sources and time and space division multispectral optical modules. In addition, novel fluorescence enhancement and background subtraction algorithms such as photothermal modulation-based laser speckle imaging technologies and coded-excitation and decoded-detection methods to improve the performance of the system. Moreover, the bio-chip technology was applied to allow for easy operations by non-specialists for greater accessibility.

The system developed by the KERI will allow local clinics and individual patients to easily monitor infectious diseases, diabetic complications, cardiac infarction, Alzheimer’s disease, and many more. It is recognized as a breakthrough technology to take the lead in the non-contact and remote healthcare industry that has soared during the COVID-19 pandemic.

One of the most important benefits of this system will be improvements in the quality of life for people living in areas with insufficient healthcare services, such as small cities, islands, and mountainous areas. Other expected outcomes include easing the over-crowded healthcare service in the capital region, spreading high-quality healthcare service throughout the local areas as well as regional economic development, and playing leading roles in the rapid growth of the local healthcare providers, for example, building disease databases in connection with artificial intelligence and medical information and communication technologies.

These technologies are up for commercialization through technical transfer agreements with two companies signed during the first half of this year, worth KRW 400 million, including VAT. They plan to work with the KERI to develop and commercialize medical devices for non-invasive diagnosis and monitoring of various diseases, including infectious diseases, in non-clinical practice within three years.

The global in vitro diagnostics market size is estimated to be KRW 80 trillion and is growing quickly year after year. Dr. Jong-Jin Kim, a Principal Researcher at the KERI and a co-investigator involved in these projects, said: “Strong economic and industrial ripple effects will be expected, which will greatly contribute to the nation’s endeavors to keep pace with advanced countries’ and leading companies’ technical development and remain competitive in the global healthcare market.” He also added: “The nationwide expansion of the base of the healthcare device providers, which has been concentrated in the capital region, will lead to the growth of healthcare-related markets in local regions and local employment induction effects, for example, expert groups to analyze and manage medical data on sites.”

The KERI has filed multiple local patent applications for the developed system, and the institute is now aiming at the early commercialization and mass production of the non-invasive biophotonics-embedded in vitro diagnostic devices in collaboration with the counterparties of the technical transfer agreements.

The KERI is a government-funded research institute under the Ministry of Science and ICT’s National Research Council of Science and Technology. <KERI>