Genalyte today launched a type 1 diabetes (T1D) antigen panel, which it said is the first multiplexed assay that measures seven autoantibodies associated with the destruction of pancreatic islet cells seen in the disease.

The T1D panel measures autoantibodies to insulin, proinsulin, GAD 65, GAD 67, IA-2 (PTPRN, ICA512), phogrin (PTPRN2, IA-2beta), and ZnT8 (SLC30A8). Running on its Maverick™ Detection System, the panel requires only a 2 to 5 μL serum or plasma sample, and is designed to provide results in less than 15 minutes without the use of dyes, fluorescent probes, or radioactive labels.

The antigen panel was developed through a $500,000 first-phase Small Business Innovation Research (SBIR) grant awarded to Genalyte by the National Institute of Diabetes and Digestive and Kidney Diseases. Genalyte won the funding to develop multiplexed assays for early detection and monitoring of T1D.

The grant also supports expansion of the approach to allow autoantibody response profiling by multiple criteria, which is expected to enhance the ability of researchers and clinicians to detect and monitor development of the disease.

In a related development, Genalyte said it is collaborating with the Barbara Davis Center for Childhood Diabetes (BDC) at the University of Colorado School of Medicine to further develop and test multiplexed antigen panels for early T1D detection.

Martin Gleeson, Ph.D., Genalyte’s CSO, noted in a statement that two BDC investigators—George Eisenbarth, M.D., Ph.D., the center’s executive director, and Liping Yu, Ph.D.—established assays for the measurement of islet autoantibodies, components of the immune system that eventually destroy the pancreatic islet cells that produce insulin.

“We are pleased to offer our innovative T1D antigen panel to diabetes researchers worldwide at the same time that we are working with Dr. Liping Yu and his lab at the Barbara Davis Diabetes Center to expand the utility of the approach,” Dr. Gleeson said.

The Maverick Detection System is designed around a proprietary, disposable consumable containing an array of microring sensors constructed using silicon photonics technology. Since the microring sensors are only 30 μm in diameter, sample volumes can be <5 μL. The system directly detects the binding of proteins or antibodies to the sensor in real-time, and results are analyzed simultaneously with the accompanying Genalyte software.

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