Revvity Launches IVDR-Certified Solution for Early Detection of Type 1 Diabetes

The kit extends Revvity’s newborn-screening platform to type 1 diabetes risk screening in early childhood.

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• Fully automated, multiplex autoantibody detection solution, enabling population-wide screening programs
• DBS-based newborn screening platform enables simple and scalable sample collection
• Expands Revvity’s diagnostic offerings from newborn into early childhood screening

WALTHAM, Mass.--(BUSINESS WIRE)-- Revvity, Inc. (NYSE: RVTY) today announced the launch of the GSP^® T1D 3plex kit, a fully automated, CE-IVDR-certified, multiplex autoantibody (AAb) detection solution to enable population-wide screening programs that identify children at risk of developing type 1 diabetes (T1D) before symptoms appear.

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

"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."

The GSP T1D 3plex kit is designed to meet the needs of emerging national T1D screening programs, providing a reliable, regulatory-compliant solution. It is the latest addition to Revvity's expanding diabetes portfolio, which spans research, clinical testing and service models.

At the European Association for the Study of Diabetes (EASD) in Milan, Italy, from September 28 – October 2, Revvity will be presenting details on both its T1D on-site installation and off-site testing service solutions developed in collaboration with Sanofi.

The GSP T1D 3plex kit will initially be available in Europe and all markets that accept CE IVD-marked products. The GSP T1D 3plex is not a U.S. Food and Drug Administration (FDA)-cleared device.

About Revvity

At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise, and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.

With 2025 revenue of $2.9 billion and approximately 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 160 countries.

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View source version on businesswire.com: https://www.businesswire.com/news/home/20260924268126/en/

Investor Relations:
Steve Willoughby
steve.willoughby@revvity.com

Media Relations:
Chet Murray
(781) 462-5126
chet.murray@revvity.com

Source: Revvity

Key Terms

ce-ivdr regulatory

CE-IVDR is the conformity marking that shows an in vitro diagnostic (IVD) medical test meets the European Union’s In Vitro Diagnostic Regulation, a set of rules on safety, performance and quality. Think of it as a safety and quality passport that the test must carry to be sold in the EU; for investors, it matters because obtaining the mark affects a company’s ability to access EU markets, timelines, regulatory costs, and commercial risk.

multiplex technical

A multiplex is a laboratory test or diagnostic method that detects or measures several different targets at the same time from a single sample, like checking for multiple ingredients in one recipe rather than cooking separate dishes. For investors, multiplex technologies can lower testing costs, speed results, and expand market reach because one product can serve multiple purposes, affecting revenue potential, production scale, and regulatory review paths.

autoantibody medical

An autoantibody is a protein made by the immune system that mistakenly targets a person’s own cells or proteins, like a security guard that starts attacking the building it’s meant to protect. For investors, autoantibodies matter because they can be used as diagnostic markers, indicate safety issues for drugs, influence clinical trial outcomes and regulatory decisions, and therefore affect the market value of diagnostics and therapeutics companies.

dried blood spots medical

A dried blood spot is a small amount of blood collected on special paper and allowed to dry, like a postage-stamp-sized sample that preserves key biomarkers for later testing. Investors care because this low-cost, easy-to-ship method makes medical testing, monitoring, and clinical trial sampling simpler and cheaper, potentially expanding market reach for diagnostics, lowering trial costs, and enabling broader patient access to health data.