GenHome Array

Even when rapid diagnosis is needed in emergency situations or frontline medical settings, existing molecular diagnostics (such as PCR) require specialized laboratories and personnel, resulting in long waiting times for results. For example, identifying the causative agent of sepsis in the emergency room can take several hours to days, often delaying treatment decisions.

While rapid antigen tests are fast, they lack accuracy and can produce false negatives. The COVID-19 pandemic highlighted the need for on-site molecular diagnostic devices, but existing products have limitations such as processing only one sample at a time or costing hundreds of dollars per test.

In short, the problem is the absence of a high-speed, multiplex, and low-cost on-site molecular diagnostic solution.

GenHome Array integrates nucleic acid extraction → isothermal amplification → result interpretation, enabling simultaneous diagnosis of multiple infectious diseases within 30 minutes, thereby significantly shortening the diagnostic workflow. By inserting a sample into a disposable cartridge with a built-in barcode, the device automatically sets the optimal temperature and time protocol for the corresponding pathogen, controlling the amplification conditions.

This eliminates the need to manually adjust amplification conditions for each pathogen, as the algorithm optimizes them, and maintains accuracy even when amplifying multiple pathogens simultaneously. Amplification products are visualized using a lateral flow assay, and a high-resolution CCD camera captures and converts them into quantified numerical results.

Users only need a few touches on the intuitive UI from cartridge loading to result confirmation, and the automatic reagent loading and dispensing minimize the risk of contamination or user error.

In summary, it can be considered a game-changer compared to existing methods in that it diagnoses multiple infectious agents simultaneously, without specialized personnel, and in a short amount of time.

The main customers are hospitals such as emergency rooms and intensive care units (emergency diagnosis), public health institutions such as public health centers and quarantine stations (on-site screening), and military units and remote medical teams (mobile diagnosis).

For example, an emergency room physician can use GenHome to analyze a sepsis patient's blood, identify the causative agent within minutes, and select an antibiotic. Public health authorities can deploy this device at airport quarantine stations or local public health centers to simultaneously test for multiple pathogens such as COVID-19 and influenza for rapid response.

Furthermore, clinics in resource-limited developing countries can use this device to make immediate and accurate diagnoses on-site, contributing to closing the global healthcare gap.

GenHome Array is not limited to specific disease groups and can be expanded to various infectious disease panels depending on the cartridge design. For example, the product line can be expanded to include a respiratory 6-virus panel, an STI 5-panel, etc.

Currently, it utilizes isothermal amplification (RT-LAMP), but new technologies such as CRISPR diagnostics are also being developed for future application through module replacement.

In terms of regulations, it must undergo approval procedures in each country as an in-vitro diagnostic medical device (such as US FDA EUA), but the pandemic experience has led to a trend of simplifying procedures such as emergency use authorization, lowering the barriers to entry compared to the past. Attoplex is already conducting trials with numerous clinical institutions and is being supported by government projects to develop emergency infectious disease kits, promoting rapid approval.

However, challenges remain until commercialization, such as establishing a large-scale production system and securing insurance reimbursement.

It was selected for the Innovation Award for "realizing lab-quality diagnostics in 30 minutes," and TrendHunter and others have commented that GenHome is a solution that will change the landscape of point-of-care diagnostics. Industry expertsEliminate high-risk elements (Powder X, High temperature X)and highly evaluate the implementation of simultaneous multi-testing, with reactions such as "an indispensable tool for emergency medicine."

Technically, it has been recognized for its contribution to miniaturization by integrating multiple functions, but on the other hand, the challenge of achieving market dominance compared to proven competitor devices (such as GeneXpert) is also pointed out. As it is still in the clinical trial stage and performance data on actual patients is limited, the judges commented, "It shone on the CES stage, but gaining the trust of the medical field is the next task."