New Autoantibody Test Targets Pre-Symptomatic Type 1 Diabetes Screening

Population-scale screening could identify children at elevated risk before symptoms develop, creating opportunities for earlier intervention and disease-modifying treatment. Supporting this approach, a newly launched, CE-IVDR-certified multiplex autoantibody test enables high-throughput early detection using dried blood spot specimens.

Revvity (Waltham, MA, USA) has introduced the GSP T1D 3plex kit, a fully automated, CE-IVDR-certified multiplex autoantibody test designed for population-wide screening programs to identify children at risk of developing type 1 diabetes before symptoms appear. The assay uses capillary dried blood spots for simple, scalable sample collection and runs on Revvity’s GSP instrument, a high-throughput platform already used in newborn screening. The launch extends the company’s diagnostic offerings from newborn screening into early childhood risk detection.

The end-to-end workflow combines reagents, instrumentation, and software to provide automated processing on the same platform. By detecting at-risk individuals months or years before symptoms develop, the 3-plex assay may support earlier intervention and disease-modifying treatment. Laboratories can also implement the workflow on existing GSP systems, helping integrate type 1 diabetes screening with established newborn screening operations.

The kit is CE-IVDR-certified and will initially be available in Europe and other markets that accept CE IVD-marked products. The GSP T1D 3plex has not been cleared by the U.S. Food and Drug Administration (FDA). It is intended to support emerging national type 1 diabetes screening programs with a regulatory-compliant testing solution.

Revvity plans to present additional details at the European Association for the Study of Diabetes (EASD) meeting in Milan, Italy, from September 28 to October 2. The company will highlight both an on-site installation option and an off-site testing service, offering laboratories different ways to implement the screening workflow. The solutions were developed in collaboration with Sanofi.

“The launch of the GSP T1D 3plex kit marks an important step forward for Revvity’s expansion into child health screening. This milestone demonstrates how our expertise in newborn screening can be leveraged to advance earlier detection in new areas of healthcare,” said Anna Godenhjelm, vice president and general manager of reproductive health at Revvity.

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