Revvity has introduced the GSP T1D 3plex kit, a CE‑IVDR‑certified, fully automated multiplex assay for early detection of type 1 diabetes risk in children using capillary dried blood spot samples. The test runs on Revvity's GSP platform—already used in newborn screening—and will be available initially across Europe and other CE IVD markets; it is not FDA cleared. Early detection aims to enable closer monitoring and access to potential disease‑modifying therapies. Revvity will present its T1D service models, developed with Sanofi, at EASD in Milan.
Revvity Launches CE‑IVDR‑Certified GSP T1D 3plex Kit for Early Childhood Type 1 Diabetes Screening
The kit was developed to address the requirements of emerging national T1D screening programmes. Credit: ANDREI ASKIRKA/Shutterstock.com.
Revvity has launched the GSP T1D 3plex kit, a fully automated, CE‑IVDR‑certified multiplex assay designed to support population screening programmes that identify children at risk of developing type 1 diabetes (T1D) months or years before clinical symptoms appear.
How the Test Works
The assay detects multiple diabetes‑related autoantibodies (AAbs) from capillary dried blood spot (DBS) samples and is processed on Revvity's GSP platform. The GSP instrument, already in routine use for newborn screening, combines dedicated reagents, instrumentation and integrated software to provide an end‑to‑end automated workflow for high‑throughput screening.
Availability And Regulatory Status
The kit will be introduced initially in Europe and in other markets that accept CE IVD‑marked products. It has not received clearance from the US Food and Drug Administration (FDA).
Clinical Implications
Earlier identification of T1D‑related autoantibodies can enable closer monitoring, earlier clinical intervention and improved access to emerging disease‑modifying treatments. The GSP T1D 3plex kit was developed to meet the needs of emerging national screening programmes for childhood T1D and to broaden Revvity's child health screening capabilities.
Anna Godenhjelm, Revvity’s vice‑president and general manager for reproductive health, said: "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."
Services And Partnerships
Revvity will present details of its T1D on‑site installation and off‑site testing services — developed in partnership with Sanofi — at the European Association for the Study of Diabetes (EASD) meeting in Milan, Italy.
Related Regulatory News
Separately, in May Revvity's Immunodiagnostic Systems (IDS) subsidiary secured FDA clearance for an automated total testosterone chemiluminescence immunoassay (ChLIA). That clearance enables direct ChLIA measurement of SHBG, total testosterone and free testosterone to support first‑line and second‑line diagnostics for suspected hypogonadism in men.
Note: The GSP T1D 3plex kit is intended for use in regions that accept CE IVD marking; clinicians and programme managers should confirm local regulatory and implementation requirements before deployment.
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