Revvity launches type 1 diabetes early detection programme with Sanofi support
Revvity has announced a comprehensive initiative to expand early detection capabilities for type 1 diabetes, combining in vitro diagnostic assay development with laboratory testing services in collaboration with Sanofi. The programme centres on advancing the company’s existing research-use autoantibody testing platform towards regulatory approval and broader clinical implementation.
From research to clinical practice
The Massachusetts-based company will develop a 4-plex in vitro diagnostic assay based on its current research-use-only 3-plex autoantibody test. The new assay is designed for Revvity’s GSP instrument platform, which supports both capillary dried blood spot and venous specimen testing. The high-throughput capabilities of the GSP system are intended to enable population-level screening programmes for early-stage type 1 diabetes detection in clinical settings.
Clinical validation and regulatory submissions for the 4-plex assay are underway, with applications planned for the US Food and Drug Administration, European Union In Vitro Diagnostic Regulation, and other major jurisdictions. The collaboration with Sanofi will support these validation and submission processes.
Expanding laboratory network capacity
In parallel, Revvity and Sanofi are working to extend access to the existing research-use product through Revvity’s global laboratory network. The assay is currently available as a laboratory-developed test at the company’s CLIA and CAP accredited Revvity Omics facility in Pittsburgh, Pennsylvania. Validation efforts will focus on implementing the assay across additional Revvity Omics locations worldwide to facilitate international access for clinical applications.
“The expansion of autoantibody testing from research-use towards convenient, affordable, high-quality and high-through-put commercial platforms such as Revvity GSP may accelerate the transition to a new clinical standard of care where people with T1D are diagnosed as early as possible,” said Shirley Gil Parrado, global head of autoimmune type 1 diabetes at Sanofi.
Clinical context and disease burden
Type 1 diabetes is a progressive auto-immune condition characterised by immune system destruction of pancreatic beta cells responsible for insulin production. Early detection enables intervention opportunities to prevent disease progression and complications including diabetic ketoacidosis. Current epidemiological data indicates that over 9 million people worldwide live with type 1 diabetes, with more than 500,000 new diagnoses annually. Notably, 90% of new cases occur in individuals without family history of the condition.
Dr Madhuri Hegde, senior vice president and chief scientific officer at Revvity, emphasised the strategic expansion: “Revvity Omics has built a reputation as a global leader in genomic testing for both rare and common conditions – pushing the boundaries of technology across multiple platforms. Today’s announcement is a pivotal step forward, showing that we’re not just capable but eager to further expand into non-rare diseases.” The initiative represents Revvity’s expansion beyond its established position in rare disease genomic testing into broader disease screening applications. With 2024 revenue exceeding $2.7 billion and approximately 11,000 employees, the S&P 500 company serves pharmaceutical, biotech, diagnostic laboratory, academic and government customers across more than 160 countries.
