Revvity has introduced a CE-IVDR-certified automated blood test designed to identify children at risk of type 1 diabetes long before clinical symptoms appear, marking a significant step towards earlier diagnosis and intervention.
Revvity has launched a new automated blood test aimed at identifying children who may be at risk of type 1 diabetes long before symptoms appear, as health systems in parts of Europe begin moving towards wider screening programmes.
The GSP T1D 3plex kit is a CE-IVDR-certified multiplex autoantibody assay, meaning it can detect several immune markers linked to type 1 diabetes in a single run. According to Medical Device Network, the test is designed for use in population screening and is being rolled out first in Europe and other markets that accept CE IVD-marked products. It is not cleared by the US Food and Drug Administration.
The assay uses capillary dried blood spot samples and runs on Revvity’s GSP instrument, a platform already used in newborn screening. Biospace reported that the system combines reagents, instrumentation and software in a fully automated workflow, with the aim of picking up children months or even years before clinical symptoms develop. Revvity says that earlier detection could open the door to early intervention and disease-modifying treatment.
Anna Godenhjelm, Revvity’s vice-president and general manager for reproductive health, said the launch marked a step forward in the company’s move into child health screening. She said the company’s experience in newborn screening could be applied to earlier detection in other areas of healthcare.
The kit is intended to meet the needs of emerging national screening programmes for type 1 diabetes, which often rely on identifying autoantibodies associated with the disease before beta-cell damage progresses too far. Revvity’s own diabetes portfolio already includes research, clinical testing and service models, and the company has also said it plans to present details of its on-site installation and off-site testing services, developed with Sanofi, at a European Association for the Study of Diabetes meeting in Milan.
The launch comes as type 1 diabetes detection is increasingly moving upstream, away from diagnosis after symptoms develop and towards finding children at risk earlier. Revvity described the GSP T1D 3plex kit as the latest step in that broader strategy, while also noting that a separate development programme is under way for a four-marker version of the test.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
