Revvity, Inc. has launched the GSP® T1D 3plex kit, a fully automated, CE-IVDR-certified, multiplex autoantibody (AAb) detection solution designed to enable population-wide screening programmes that identify children at risk of developing type 1 diabetes (T1D) before symptoms appear.

The company notes that T1D is often identified only after significant beta-cell damage has occurred, presenting first as a life-threatening diabetic ketoacidosis (DKA) episode. The 3-plex assay uses capillary dried blood spots (DBS) for simple, scalable sample collection and is processed on Revvity’s GSP instrument, which it describes as a high-throughput, trusted platform in newborn screening. The end-to-end workflow, which includes reagents, instrumentation and software, can detect at-risk individuals months or years before symptoms, according to Revvity, enabling early intervention and disease-modifying treatment.

The kit targets critical autoantibodies associated with insulin-producing beta cells in a single multiplex assay, which Revvity describes as an efficient method for simultaneous, quantitative detection of antibodies. The three antibodies tested are:
• GAD65 (glutamic acid decarboxylase 65);
• IA-2 (islet antigen-2); and
• ZnT8 (zinc transporter 8).

Extending newborn screening into early childhood

Revvity highlights three attributes of the offering:
• a fully automated, multiplex autoantibody detection solution that enables population-wide screening programmes;
• a DBS-based newborn screening platform that enables simple and scalable sample collection; and
• an expansion of Revvity’s diagnostic offering from newborn into early childhood screening.

The kit is designed to meet the needs of emerging national T1D screening programmes, providing what the company calls a reliable, regulatory-compliant solution. It is the latest addition to its diabetes portfolio, which spans research, clinical testing and service models.

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

Presentation at EASD

Revvity presented details of both its T1D on-site installation and off-site testing service solutions, which were developed in collaboration with Sanofi, at the European Association for the Study of Diabetes (EASD) meeting in Milan, Italy, from 28 September to 2 October.

Availability and regulatory status

The GSP T1D 3plex kit will initially be available in Europe and in all markets that accept CE IVD-marked products. Revvity notes that the kit is not cleared by the US FDA.

Revvity provides health science solutions, technologies, expertise and services spanning workflows from discovery to development and from diagnosis to cure, with specialised focus areas including translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, and informatics. The company reports 2025 revenue of $2.9 billion and approximately 11,000 employees, and serves customers in more than 160 countries across pharmaceutical and biotech, diagnostic laboratories, academia and governments. It is part of the S&P 500 index.

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