Revvity has launched the GSP T1D 3plex kit, a fully automated, CE-IVDR-certified multiplex autoantibody detection solution designed to support population-level screening programmes for children at risk of developing type 1 diabetes (T1D) months or even years before clinical symptoms appear.
The T1D screening kit will initially be available across Europe and in markets that accept CE IVD-marked products. It is not cleared by the US Food and Drug Administration (FDA). The assay relies on capillary dried blood spot (DBS) samples and is processed on Revvity’s GSP instrument — a platform already widely used in newborn screening programmes. The workflow integrates reagents, instrumentation, and dedicated software into a unified system.
The GSP T1D 3plex kit was specifically developed to meet the requirements of emerging national T1D screening programmes. It forms part of Revvity’s broader diabetes portfolio, which spans research, clinical testing, and service models aimed at supporting healthcare systems at multiple levels.
Earlier identification of autoantibody presence is expected to support timely intervention and access to disease-modifying treatment, which remains a core objective for national health programmes tracking paediatric diabetes risk.
Revvity’s Vice-President and Reproductive Health General Manager, Anna Godenhjelm, commented on the significance of the launch: “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.”
On-Site and Off-Site Testing Services in Partnership with Sanofi
Revvity plans to present details on its T1D screening kit on-site installation and off-site testing services at the European Association for the Study of Diabetes meeting in Milan, Italy. These services have been developed in partnership with Sanofi and represent an extension of the company’s commitment to supporting national diabetes detection initiatives across Europe.
In a related development, Revvity received FDA clearance in May for a total testosterone automated chemiluminescence immunoassay (ChLIA) through its Immunodiagnostic Systems (IDS) subsidiary. This offering enables direct ChLIA measurements of SHBG, total testosterone, and free testosterone, delivering both first-line and second-line diagnostic capabilities for identifying suspected hypogonadism in men.
The autoantibody detection capabilities embedded in the GSP T1D 3plex kit, combined with Revvity’s established footprint in newborn screening, position the company to support the growing demand for early-stage paediatric disease identification across European healthcare markets.