Revvity, Inc. announced a major expansion of its Type 1 diabetes (T1D) diagnostics portfolio through the development of a population-scale early detection assay, supported by Sanofi (EURONEXT: SAN and NASDAQ: SNY). The initiative aims to revolutionize how T1D is identified and managed globally, moving from symptomatic diagnosis to proactive screening and intervention.
At the center of the program is Revvity’s plan to develop a T1D 4-plex in vitro diagnostic (IVD) assay, building on its existing research-use-only (RUO) 3-plex assay. The new test will be designed for clinical use and scaled for large population screening—potentially enabling early diagnosis before the onset of symptoms or life-threatening complications.
Addressing an Urgent Global Health Challenge
Type 1 diabetes is a chronic, progressive autoimmune disease in which the body’s immune system destroys the insulin-producing beta cells of the pancreas. The loss of insulin production leads to elevated blood glucose levels and, without treatment, can result in serious complications such as diabetic ketoacidosis (DKA), heart disease, kidney failure, and nerve damage.
Although advances in insulin therapy and continuous glucose monitoring have transformed disease management, early detection remains the most powerful way to change the course of T1D. Identifying individuals during the presymptomatic phase—when autoantibodies against pancreatic cells are present but symptoms have not yet appeared—enables interventions that may delay or even prevent disease onset.
More than 9 million people worldwide currently live with T1D, and over 500,000 new cases are diagnosed each year, according to global health estimates. Strikingly, about 90% of new cases occur in individuals with no family history of the disease, underscoring the importance of population-based screening rather than focusing solely on those with known genetic risk.
Scaling Early Detection for Population Screening
The collaboration between Revvity and Sanofi will focus on clinical validation and regulatory submissions for the new T1D 4-plex assay. The test will run on Revvity’s established GSP® instrument, a high-throughput analytical platform widely used in newborn screening and diagnostic testing programs around the world.
The assay will be compatible with both capillary dried blood spot (DBS) and venous blood samples, offering flexible sample collection methods for use in both clinical and public health settings. This design makes it particularly suitable for large-scale population screening, including pediatric programs and public health initiatives aimed at early identification of autoimmune conditions.
Revvity plans to pursue regulatory approvals with the U.S. Food and Drug Administration (FDA), the European Union’s In Vitro Diagnostic Regulation (IVDR) framework, and other major global regulatory agencies. Once approved, the test will represent a new class of accessible, high-quality, and high-throughput autoantibody assays for early T1D detection.
A Step Toward a New Clinical Standard
“The expansion of autoantibody testing from research-use tools toward convenient, affordable, and clinically validated platforms such as Revvity’s GSP® system may accelerate the transition to a new standard of care,” said Shirley Gil Parrado, Global Head of Autoimmune Type 1 Diabetes at Sanofi. “Diagnosing people with T1D as early as possible gives them the best chance to benefit from emerging preventive therapies and proactive disease management strategies.”
Sanofi has been a global leader in developing and supporting immunomodulatory treatments aimed at altering the progression of autoimmune diseases. Its collaboration with Revvity underscores a shared commitment to integrating diagnostics and therapeutics to redefine how autoimmune diseases like T1D are managed—from prevention and early detection to treatment and long-term care.
Expanding Global Access Through Revvity Omics
In addition to developing the new IVD assay, Revvity and Sanofi are collaborating to expand access to Revvity’s existing research-use-only 3-plex product. Currently available as a laboratory-developed test (LDT) through the CLIA- and CAP-accredited Revvity Omics laboratory in Pittsburgh, Pennsylvania, the assay enables detection of multiple diabetes-related autoantibodies that signal early autoimmune activity.
As part of the collaboration, Revvity plans to validate and deploy this assay across its global network of laboratories, broadening access for healthcare systems, research organizations, and clinical trial partners worldwide. This global expansion will allow more patients and clinicians to benefit from advanced early-detection tools, particularly in regions where T1D incidence is rapidly rising.
Scientific Leadership and Broader Vision
“Revvity Omics has established itself as a global leader in genomic and biomarker testing, serving both rare and common diseases,” said Dr. Madhuri Hegde, Senior Vice President and Chief Scientific Officer at Revvity. “This announcement marks a pivotal moment as we expand our technology’s impact beyond rare disease diagnostics into common autoimmune conditions like T1D.”
Dr. Hegde emphasized that the collaboration with Sanofi reflects the growing recognition that early detection and precision diagnostics are essential complements to pharmaceutical innovation. “By working closely with a partner like Sanofi, we’re ensuring that diagnostic assays can identify patients who will benefit most from emerging therapeutics. This is the future of integrated healthcare—diagnostics and drug development advancing together to improve outcomes.”
Revvity’s GSP® technology has already been deployed in over 90 countries, supporting national screening programs for newborns and rare diseases. With the addition of the T1D 4-plex assay, Revvity aims to extend its impact to millions of individuals at risk for autoimmune diabetes, laying the groundwork for a new generation of public health diagnostics.
Building a Foundation for Preventive Medicine
The broader implication of this program extends beyond Type 1 diabetes. Autoimmune disorders often develop silently over years, and by the time symptoms emerge, significant tissue damage has already occurred. Population-level screening tools like Revvity’s new assay could form the foundation of preventive medicine frameworks, allowing earlier detection of immune dysregulation and timely intervention across a range of diseases.
Through its partnership with Sanofi, Revvity is positioning itself at the forefront of translational diagnostics, bridging the gap between laboratory research and global clinical implementation. This alignment of diagnostic innovation and therapeutic development represents a new model for tackling chronic, complex diseases such as T1D—where prevention, precision, and personalization converge.
“With this collaboration, we’re taking a decisive step toward making early detection of Type 1 diabetes accessible at a population level,” said Dr. Hegde. “By enabling screening at scale, we can help clinicians intervene earlier, improve patient quality of life, and ultimately change the trajectory of this lifelong condition.”
