New Type 1 Diabetes Diagnostic Antigen Panel Now Available, Collaboration to Further Advance Panel

A new multiplexed, early diagnosis biomarker-panel assay that measures autoantigens associated with the development of Type 1 Diabetes is now available. A specially funded collaboration is also underway to further advance the assay.

The Maverick Type 1 Diabetes (T1D) Assay from Genalyte, Inc. (San Diego, CA, USA) is the first multiplexed assay that measures 7 autoantibodies associated with the destruction of pancreatic islet β cells seen in T1D. In addition, new preventative therapies may have the potential to reduce or stop this cell destruction in patients at risk—identifying these patients early would facilitate the development and use of these therapies.

The Maverick T1D Assay is a semiquantitative photonic ring immunoassay designed to simultaneously detect the antigens. The Maverick Detection System analyzes each antigen individually and reports results in less than 15 minutes, without the use of dyes, fluorescent probes, or radioactive labels. The assay requires only 2–5 μL serum or plasma sample and minimal hands-on time. It measures autoantibodies to insulin, proinsulin, glutamate decarboxylases GAD65 and GAD67, IA-2 (PTPRN, ICA512), phogrin (PTPRN2, IA-2ß) and ZnT8 (Zinc Transporter 8, SLC30A8).

The Maverick Detection System itself is based on Genalyte’s Microring Sensor Technology to reduce or eliminate sample preparation and provide scalable multiplexing for both proteins and nucleic acids. Its one-step workflow can rapidly deliver accurate results from small volume samples of many types. It has a large dynamic range and excellent sensitivity and reproducibility.

Genalyte is collaborating with the Barbara Davis Center for Childhood Diabetes (BDC; Aurora, CO, USA) at the University of Colorado School of Medicine to further develop and test panels for early detection of T1D. The current T1D panel was developed as part of the first phase of a Small Business Innovation Research grant awarded to Genalyte to develop multiplexed assays for early detection and monitoring of T1D. A USD 500,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases also supports expansion of the approach to allow autoantibody response profiling by multiple criteria to enhance the ability to detect and monitor disease development. “The pioneering work of Drs. George Eisenbarth and Liping Yu at BDC established assays for the measurement of islet autoantibodies. [...] The unique capabilities of our Maverick detection platform have the potential to provide researchers and clinicians with tools to detect and track this process from an early stage, when interventions to interrupt the disease process may be feasible,” said Martin Gleeson, PhD, Chief Scientific Officer of Genalyte.

“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,” added Dr. Gleeson.

Maverick assays are currently available for research use only. Genalyte also offers a Custom Spotting Service for various proteins supplied by customers.

Related Links:
Genalyte
Barbara Davis Center for Childhood Diabetes