The OBM rapid A1c test helps to detect and manage diabetes. Credit: Orange Biomed / PRNewswire.

Healthcare start-up Orange Biomed has launched its pocket-sized, reusable OBM rapid A1c test in the US to fill the testing gaps for people with pre-diabetes and diabetes.

Claimed to be the first glycated haemoglobin analyser in the world, the OBM rapid A1c technology is planned to be unveiled at the 83rd Scientific Sessions of the American Diabetes Association, to be held in San Diego, California, in June this year.

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The portable and more accurate OBM rapid A1c test helps to detect and manage diabetes through single-cell analysis of red blood cells.

The portable design allows the device to be carried from patient to patient at clinics. It provides immediate test results within five minutes and does not require calibration or maintenance.

The long-lasting device can be used to monitor the health status of multiple family members at home.

Currently, OBM rapid A1c is being evaluated in global trials with Asan Medical Center.

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The company stated that OBM rapid A1c is unaffected by haemoglobin variants and ensures accurate results for diverse patient populations. The haemoglobin variants are more common in people from some parts of the world such as Africa, South Asia and the Mediterranean.

Orange Biomed co-founder Yeaseul Park said: “Current technologies are likely to produce inaccurate A1c results disproportionately more for non-white patients due to haemoglobin variants.

“Inaccurate results can delay diabetes diagnosis and serious long-term health damage.

“OBM rapid A1c is a portable, guided, five-minute test requiring only a single drop of blood to produce accurate results.

“By seamlessly integrating lab-level technology into portable devices, we seek to make healthcare more accessible, accurate and affordable for everyone.”

The company has raised more than $2m in cumulative investments in pre-series A funding rounds. It aims to secure Food and Drug Administration approval for OBM rapid A1c within one year.