FDA Panel Backs Diabetes Diagnostic Device

An FDA advisory panel recently gave the green light for a hemoglobin A1C test to diagnose diabetes in certain care settings.

An FDA advisory panel recently gave the green light for a hemoglobin A1C (HbA1C) test to diagnose diabetes in certain care settings.

The FDA’s Clinical Toxicology Devices advisory committee recently considered whether or not device manufacturer Alere should be permitted to market its Afinion HbA1C Dx assay as a diagnostic tool for diabetes.

Currently, the Afinion HbA1C assay is used as an aid to identify at-risk patients in hospitals and other care settings. It received FDA 501(k) clearance in 2005.

Speaking on behalf of Alere, Richard Kahn, PhD, said point-of-care A1C diagnostic testing has the potential to greatly boost the detection rate of diabetes, and false negatives or false positives would have little impact.

“The potential benefits of point-of-care A1C for diagnosis are significant while the potential risks are minimal,” Dr. Kahn said.

The FDA panel’s backing wasn’t unanimous. Certain stakeholders expressed concern about the accuracy of such tests in diagnosing diabetes.

“The value of point-of-care A1C testing is for education and for therapeutic changes within an individual patient. Ideal situations for laboratory testing are necessary for labeling of individuals with diabetes,” said Robert Ratner, MD, chief scientific and medical officer for the American Diabetes Association. “…Once we make a diagnosis, it has significant implications for the individual, their employer, and society. It makes a huge difference going from a management standpoint to a diagnosis standpoint.”

Meanwhile, panel member Robert E. Burr, MD, an endocrinologist, said that clinicians are essentially already using such devices off-label to diagnose diabetes.

“It's the same machine, the same results, the same data,” he asserted.

If given full FDA clearance, the Afinion HbA1C Dx would be the first HbA1C test labeled for point-of-care use to diagnose diabetes. It would also be indicated for ongoing HbA1C monitoring of diabetes patients, so clinicians wouldn’t need 2 separate machines.