Micromedic Technologies' radio immuno-assay kit for the early detection of diabetes has been shown to work better than existing technologies, the company said on Wednesday.
The technology underlying the diagnostic kit, designed to detect type 1 diabetes and latent autoimmune diabetes in adults (LADA), is based on research by Nathan Karin of the Rappaport Institute and Naim Shehadeh, head of Pediatrics A and the Type 1 Diabetes Center at Rambam Medical Center.
Karin and Shehadeh had developed a biomarker capable of detecting type-1 and LADA at early stages. The antibody in the kit identified 83.3% of the cases in 60 samples, while in the control group of healthy people it identified 13.3% false positives. Current tests for type-1 diabetes have an efficacy rate of only 70%, says Karin.
A biomarker is a molecule that reacts when encountering its target. In this case it is an antibody that reacts to evidence of diabetes.
The efficacy tests were carried out at the Technion medical school by BioRap Technologies, the technology transfer company of the Technion's medical sciences school. BioRap has given MicroRap, an 85% subsidiary of Micromedic, an exclusive global license to use the know-how.
Micromedic will now apply for approval to market the diagnostic kit, starting with Europe and later heading for the United States. The company says European approval could be forthcoming as early as the second half of 2009.
Type-1 diabetes, also known as juvenile diabetes, is often found in people under 30. It is caused by the immune system mistakenly attacking and destroying the insulin-producing cells in the pancreas. Insulin is a hormone that controls the level of sugar in the blood and helps transport the sugar - glucose - to the cells.
Without adequate levels of insulin, glucose can't enter the cells and builds up in the bloodstream.
Seven percent of the U.S. population suffers from some sort of diabetes. Each year 1.5 million new cases are diagnosed, and between 10% to 15% are estimated to have type-1 diabetes.
Last week Micromedic announced success in another clinical test, of a biomarker to diagnose cancer in the intestinal tract.