Next-generation diabetes monitoring: Orange Biomed’s microfluidic breakthrough

Hemoglobin A1C (HbA1c) is a form of hemoglobin found in red blood cells. The HbA1c blood test measures the average amount of glucose that’s been attached to hemoglobin over time. The more glucose there is in blood, the more it sticks. And it can stay there for around 120 days — about how long the average red blood cell lives. This test is commonly used to diagnose prediabetes and type 2 diabetes, as well as monitor how well a patient’s diabetes treatment plan is working.

Normally, red blood cells bend easily to squeeze through tiny capillaries, but glycated cells are stiffer and less flexible. This makes blood flow less smooth. Orange Biomed has created the first portable and reusable HbA1c test method requiring no refrigeration, maintenance, or calibration for patients to use at home. The device uses a microfluidic chip with tiny channels that mimic human capillaries. A fingerstick of blood flows through these channels, and sensors measure how easily the cells move. The stiffer the cells, the higher the A1C. The device is being prepared for 510(k) submission to the U.S. Food and Drug Administration.

Is Orange Biomed’s rapid A1C test as accurate as traditional laboratory testing?

It’s important to recognize that high-performance liquid chromatography (HPLC) in laboratories is considered the gold standard for A1C testing, and ADA guidelines recommend it for diagnosis. Conventional point-of-care or smaller portable devices have typically sacrificed some accuracy because they rely on protein-based assays. Making these reagent-dependent systems smaller usually means losing precision, and that’s why there’s a widespread perception that compact A1C devices cannot be as accurate as lab equipment.

Our technology is different. Because we do not depend on protein quantification, but instead directly analyze the physical properties of red blood cells, the limitations of miniaturization do not apply in the same way. That’s why even in a portable, reusable form, our test can potentially achieve laboratory-level precision.

Accuracy also has another dimension: consistency across different users and environments. In laboratories, even the same HPLC system can vary greatly depending on how well it is maintained, calibrated, and operated by trained professionals. For home use, this variability is unacceptable. That’s why our device was designed to require no calibration, no refrigeration, and no professional maintenance. It minimizes user-dependent error, and its microfluidic system is not affected by variations in sample volume that often introduce inaccuracies in reagent-based methods.

So while the gold standard will remain in central labs, our innovation demonstrates that portable devices do not necessarily mean compromising accuracy—if the underlying principle is fundamentally different.

Why is the OBM rapid A1C unaffected by hemoglobin variants, and why is that clinically significant?

Hemoglobin variants are found in all populations, though their frequency is higher in certain groups. For example, HbS and HbC are more common among individuals of African descent, while HbE is more prevalent in Southeast Asia. These variants are structurally similar to HbA. Conventional A1C assays work by separating hemoglobin proteins and quantifying HbA and HbA1c, but variants make this separation less precise. As a result, even laboratory gold-standard systems like HPLC can show interference, producing inaccurate A1C values—let alone conventional point-of-care devices.

Our method takes a fundamentally different approach. Instead of separating proteins, we measure the deformability of red blood cells as they pass through microfluidic channels. Hemoglobin variants themselves do not change deformability.

This means that by design, our device is free from hemoglobin variant interference. Clinically, this provides more consistent and equitable results across patient populations, addressing a long-standing gap in diabetes care.

How do you envision the OBM rapid A1C test changing patient diabetes management?

A1C is a critical long-term marker of glucose control, yet many patients only test once or twice a year in clinics—well below the frequency recommended in clinical guidelines.

• Research from Australia has shown that patients who tested more frequently maintained or improved glycemic control over time, while those with less frequent testing often saw their control deteriorate. More frequent testing was also associated with a lower risk of developing chronic kidney disease (PMC8380884).
• A study in South Africa similarly found that patients who repeated A1C testing every 2–4 months were more likely to lower their HbA1c, and those adhering to recommended testing intervals achieved better overall outcomes (BMC Endocrine Disorders).

Importantly, even a 1% reduction in A1C is associated with about a 30–40% decrease in microvascular complications, according to landmark studies. This means that simply increasing access to testing—and enabling patients to follow recommended testing frequency—can lead to meaningful improvements in outcomes.

However, one of the main reasons patients fail to meet these recommendations is the difficulty of accessing clinic-based testing.

By making lab-quality A1C testing available at home or through local pharmacies, the OBM rapid A1C test removes this barrier. It empowers patients to:

- Monitor their long-term glucose control more regularly

- Adjust lifestyle and treatment plans in a timely way

- Reduce uncertainty about their health status

- Ultimately lower A1C levels and reduce the risk of diabetes complications

What potential do you see for microfluidics beyond HbA1c testing?

Traditional diagnostics often rely on large blood draws, bulky equipment, and centralized laboratories. This model is costly and creates barriers to timely testing, especially in rural or underserved areas. Microfluidics changes this dynamic. By manipulating volumes smaller than a microliter, it enables complex analyses from just a finger prick of blood—making testing less invasive, more comfortable, and more accessible.

The potential extends far beyond diabetes. Microfluidic platforms are uniquely suited for personalized medicine, where treatment decisions are tailored to each patient’s biology. As the technology advances, these systems could perform multiplexed assays that integrate genomics, proteomics, and metabolomics into a single compact device.

Looking ahead, it’s possible to imagine a future where a small device at home can monitor immune status, detect early signs of cancer, or measure how well a therapy is working—all from just a few drops of blood. In the end, microfluidics is not just a breakthrough in fluid control—it’s a breakthrough in how we approach human health, opening new possibilities for care one drop at a time.

Unghyeon Ko is the Co-Founder and President of Orange Biomed, leading the company's technology development and innovation. Dr. Ko began researching innovative diabetes management technology in 2019 alongside co-founder Yeaseul Park. Two years later, he founded Orange Biomed, established its corporate R&D center, and initiated a clinical trial partnership with Seoul Asan Medical Center.

Prior to Orange Biomed, Dr. Ko conducted postdoctoral research in Biomedical Engineering at Duke University, specializing in microfluidics, soft robotics, the blood-brain barrier, regenerative medicine, and smart materials.

He holds a BS, MS, and PhD in Mechanical Engineering from the Korea Advanced Institute of Science and Technology (KAIST).