The Seattle-based company received Good Manufacturing Practice (GMP) certification for in vitro diagnostic medical devices from Korea’s Ministry of Food and Drug Safety. This enables it to scale production of the pocket-sized portable diabetes testing device.
Orange Biomed’s OBM rapid A1C device delivers lab-quality hemoglobin A1C testing in a small, easy-to-use unit. It works in hospitals and clinics but can also extend to pharmacies and the home, according to the company. Orange Biomed designed it with the world’s first single-cell microfluidic analysis technology. This enables faster, more accurate testing to potentially make daily diabetes management more accessible.
The company featured in Drug Delivery Business News’ list of 11 diabetes startups you need to know in 2023.
To date, Orange Biomed boasts more than $7.5 million in funding as it moves toward bringing the A1C test to market. It currently has preparations underway for an FDA 510(k) submission. The company seeks over-the-counter clearance first, then expects to follow with a submission for point-of-care (POC) use.
“We think portable, patient-friendly devices like ours will change how people manage chronic conditions,” said Yeaseul Park, CEO of Orange Biomed. “This certification proves we can manufacture to global standards and deliver a product people can trust.”
