Doctors in the US will have a new tool to help tackle the growing epidemic of diabetes after the FDA approved Roche's assay as the first blood sugar test to diagnose the condition.
Roche's Cobas Integra 800 Tina-quant HbA1cDx assay and other similar tools to measure blood sugar are already used to monitor the glucose control of people with diabetes, but this is the first time the FDA has cleared this method as a diagnosis test.
The approval reflects the evolving nature of diabetes diagnosis, with the FDA noting that many healthcare professionals, influenced by recommendations from experts, are already using HbA1c tests, which measure the patient's average glucose level over a three-month period, to diagnose diabetes.
There is a difficulty in knowing which HbA1c tests are accurate enough for this purpose, however, and the FDA backing will boost confidence in Roche's assay.
“Providing healthcare professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appropriate guidance on treatment before problems develop,” said Dr Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Devices at FDA's Center for Devices and Radiological Health.
Diabetes is a major health problem in the US, where 25.8 million people (about 8 per cent of the population) are estimated to live with the condition.
This includes about seven million people who remain undiagnosed, and the approval of Roche's device will boost existing diagnostic efforts that currently include a fasting blood glucose test and an oral glucose tolerance test.
The FDA said the Tina-quant HbA1cDx assay demonstrated its ability in a trial involving 141 blood samples.
The experiment found there was less than a six per cent difference in the accuracy of test results from the Roche's assay compared to results from the standard reference for haemoglobin analysis.