1. Overview of the Applied Product

a. Applied Product Name (English Name): Real-time Gene Amplification Device (MoiM Dx100, MoiM Dx200)

b. Purpose

It is utilized as a constant molecular diagnostic testing platform in on-site molecular diagnostics (POC), emergency on-site diagnostics, and disease response centers within the human and animal infectious disease prevention system. It enables rapid and accurate molecular diagnostics even in environments with insufficient medical infrastructure, contributing to the elimination of medical blind spots and the reduction of disparities in medical services between regions.

c. Main Functions

It is an all-in-one molecular diagnostic platform that satisfies high performance, rapidity, multiplex diagnostics, low cost, and user convenience. It provides rapid and accurate diagnosis of up to 16 targets within 1 hour, and features a 'Sample to Answer' function where the entire process of extraction, amplification, and analysis is automated with just sample injection, making it easy for non-experts to use.

d. Novelty of the Developed Technology (Describe whether the core technology of the applied product is a domestic first new technology or an applied technology that innovatively improves or enhances existing technologies, and include the details of the core technology application)

1. The only all-in-one molecular diagnostic platform that satisfies a wide range of market requirements.

Based on previously filed patents for a diagnostic platform that meets the requirements of point-of-care (POC) platforms—① user convenience (Sample to Result), ② high multiplexity using a single sample, ③ rapid results suitable for POC environments (results within 1 hour), and ④ contamination removal suitable for POC environments (Closed system)—we have advanced the platform, secured performance, manufactured all-in-one cartridges, conducted reagent performance tests, and completed the product through clinical trials and regulatory approvals. Currently, worldwide, only a few companies have commercialized products, but none fully satisfy the wide range of product requirements arising from on-site use. Cepheid, which leads in user convenience and performance, monopolizes the market, but our product, which meets all unmet needs, can lead the market.

2. On-site molecular diagnostic platform capable of quantitative testing for chronic infectious diseases

(1) Existing commercialized microfluidic methods have limitations in quantitative testing (high performance) due to deviations more than 10 times greater than large-scale equipment, restricting expansion to quantitative testing and high-sensitivity diagnostic items for chronic infectious disease patients diagnosed on large equipment. (2) Our company has miniaturized and implemented large-scale equipment pipetting and magnetic extraction technologies into an all-in-one platform, rather than using existing microfluidic methods, providing a high-performance solution superior to existing commercialized POC performance. This enables expansion to quantitative testing for chronic infectious diseases, overcoming the limitations of existing POC market expansion and demonstrating high performance.

3. Third-generation semiconductor-based Thermal Cycling technology We have achieved twice the speed of temperature control and half the power consumption compared to existing technologies by implementing our unique low-power, high-efficiency platinum thin-film heater manufacturing and ultra-high-speed/high-precision temperature control technology.
4. Fluorescence detection technology We have developed and secured control technology for 4-color fluorescence detection that achieves a compact structure and high detection performance by combining our detection optical technology, signal amplification circuits, and design technologies.

e. Core Contents of the Developed Technology (Describe how the structure and performance of existing products have been improved, including diagrams or photos)

1. Our innovative technological competitiveness Our technology satisfies all market requirements in performance, rapidity, multiplex diagnostics, price competitiveness, and user convenience compared to existing technologies, thereby addressing unmet needs in the market and removing constraints on market expansion.

(1) High performance: We have miniaturized high-precision pipetting technology used in large equipment and developed our own control technology to implement an on-site high-performance molecular diagnostic platform capable of quantitative analysis equivalent to large equipment. This not only minimizes errors caused by the use of microfluidic technology in existing similar products but also enables more accurate and precise results. It shows an error rate of less than 0.5% in official clinical trials, demonstrating reliable and stable operation. (2) Rapidity: Rapid diagnostic equipment that allows on-site prescription through on-site diagnosis with test results within 1 hour. (3) Multiplex diagnostics: Capable of detecting up to 16 targets, with easy control of multiplex diagnostic levels, making it a diagnostic device capable of various multiplex diagnostics. This fundamentally solves the problems in existing similar products where separate cartridges are used to increase detectable targets or where errors increase in products with expanded multiplex diagnostics. (4) Low cost: By simplifying the structure and producing reagents directly, we remove the high-price constraints of existing similar products, enabling use in underdeveloped countries and a wide range of markets. (5) User convenience: Through the internalization and commercialization of high-performance freeze-dried beads, room-temperature storage is possible, and all tests can be performed with just sample injection, maximizing usability with a 3-step process of sample injection, loading, and test start, without any preprocessing by the tester. (6) Sample applicability: Applicable to respiratory samples, sputum, culture samples, and difficult samples for existing similar products such as stool and blood (whole blood, plasma) with minimal preprocessing.

2. High-performance, low-cost all-in-one cartridge (1/2 the level compared to existing) By achieving the high performance of large equipment in a point-of-care (POC) diagnostic platform, it is the only platform that expands market entry areas and satisfies a wide range of market demands. We have implemented an all-in-one cartridge at a price below the level of consumables used in large equipment, enabling rapid market entry based on high price competitiveness, and expansion not only to advanced countries and domestic markets but also to middle- and low-income developing countries worldwide. Through an all-in-one cartridge capable of quantitative testing for chronic infectious diseases, it is the only high-performance platform and cartridge worldwide, excluding Cepheid.
3. Integration technology of platform and cartridge Securing market competitiveness through higher cost competitiveness of all-in-one cartridge and platform compared to competitors.
4. Accurate and precise liquid handling technology a. By internalizing ultra-small pipette module technology, we have secured high-precision liquid handling technology with CV% less than 2% for 50uL fluid control. b. We have secured control technology that enables high-performance extraction efficiency regardless of various clinical sample types, reducing error rates to less than 1%.

c. Ripple Effects on Related Industries MoiM Dx100 and Dx200 are expected to bring the following positive ripple effects to the domestic and international in vitro diagnostics industry and society as a whole: • Economic and social cost savings: By replacing expensive imported molecular diagnostic products, it improves hospital profitability, reduces patients' medical expense burdens, and dramatically reduces national social medical costs by decreasing unnecessary hospital revisits and hospitalization days through rapid diagnostic results. With low price competitiveness, it enables widespread market penetration, including in underdeveloped countries, leading to import substitution effects and expansion of the domestic in vitro diagnostics industry scale. • Environmental contribution: Through room-temperature storage of freeze-dried reagents and low-power design (platinum thin-film heater technology), it eliminates the need for frozen transportation, avoids dry ice usage, and reduces power consumption by up to 80%, significantly contributing to energy savings and greenhouse gas (CO2) reduction. Additionally, the all-in-one cartridge design simplifies packaging and reduces plastic waste, leading important technology trends in ESG aspects. • Expansion of industrial ecosystem and job creation: It accelerates the localization of the point-of-care diagnostic platform market, which has relied on imports, and expands the market to small and medium-sized hospitals and regions previously unable to perform molecular diagnostics, thereby enlarging the scale of the domestic in vitro diagnostic medical device manufacturing industry. Various jobs can be created in the manufacturing-based development and production processes, and further global market entry will lead to collaborative growth in the industry. • Improvement of national health and medical services: It enables rapid and accurate diagnostics even in areas with insufficient medical infrastructure or in disaster situations, eliminating medical blind spots and reducing regional disparities in medical services. In the event of infectious disease outbreaks, it strengthens the national quarantine system's golden time response capabilities through rapid on-site diagnostics and real-time status analysis via network integration, enhances response to new variant infectious diseases and public safety, and is expected to contribute to strengthening the global status of K-Bio.