The U.S. Food and Drug Administration (FDA) has approved the first rapid diagnostic test for diabetes, as announced by Abbott, the maker of the test.
Up to this point, all HbA1c (a measure of long-term blood glucose control) tests approved for diagnosing diabetes have used central laboratory instruments — machines that require too much space and expertise for smaller medical facilities to have on-site.
The newly approved test uses a smaller machine by Abbott, known as the Afinion AS100 Analyzer. This machine is already widely used in health-care settings to test for both HbA1c and albumin-to-creatinine ratio (ACR) — a marker of kidney function.
While the newly approved test isn’t functionally different from Abbott’s currently used rapid HbA1c test, the older version of the test wasn’t approved for diagnosing diabetes. It was approved by the FDA in 2005 for “patient management of diabetes at the point of care” — in other words, to help make treatment decisions for people with established diabetes.
“With our new expanded test indication, patients at risk for diabetes can receive their assessment within minutes, allowing them to work with clinicians to customize a care plan during a single visit,” says Elizabeth Balthrop, divisional vice president for Cardiometabolic and Informatics at Abbott. “This is especially impactful for patients who can’t easily access or make multiple appointments at labs and doctor’s offices.”
The test will be available in the United States in late 2018, according to Abbott.