Revvity Partners with Sanofi to Develop Population-Scale Type 1 Diabetes Screening Test
核心洞察
Revvity (搜索) and Sanofi are collaborating to develop a four-plex in vitro diagnostic test for early-stage Type 1 diabetes (搜索) screening, expanding from Revvity's existing three-plex research-use-only assay.
The new test will detect four autoantibodies (搜索) indicating early Type 1 diabetes (搜索) stages using dried blood spot and venous blood specimens on Revvity (搜索)'s GSP instrument platform.
The collaboration aims to enable population-level screening and early intervention to prevent disease progression and complications like diabetic ketoacidosis (搜索) in the over 9 million people worldwide living with Type 1 diabetes (搜索).
Revvity (搜索) announced Thursday a collaboration with pharmaceutical giant Sanofi to develop a population-scale screening test for early detection of Type 1 diabetes (搜索), marking a significant advancement in autoimmune disease (搜索) diagnostics. The partnership aims to transform the current standard of care by enabling earlier intervention to prevent disease progression and life-threatening complications.
Expanding Diagnostic Capabilities
The collaboration centers on developing a four-plex in vitro diagnostic (IVD) assay based on Revvity (搜索)'s existing three-plex research-use-only assay. The new test is designed to detect four autoantibodies (搜索) that may indicate early stages of Type 1 diabetes (搜索), utilizing both dried blood spot and venous blood specimens on Revvity's GSP instrument platform.
"The expansion of autoantibody testing from research-use towards convenient, affordable, high-quality and high-throughput commercial platforms such as Revvity (搜索) 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 (搜索) at Sanofi.
The GSP instrument's high throughput capability is specifically designed to enable population-level screening for early-stage Type 1 diabetes (搜索) in clinical practice, representing what the companies describe as an important advance in the evolution of standard care protocols.
Addressing Critical Medical Need
Type 1 diabetes (搜索) affects over 9 million people worldwide, with more than 500,000 new cases diagnosed annually. Notably, 90% of new diagnoses occur in individuals without a family history of the disease. The condition is a lifelong, progressive autoimmune disorder where the immune system mistakenly attacks insulin-producing beta cells (搜索) in the pancreas.
Early detection enables healthcare providers and patients to implement interventions that can prevent the natural progression of the disease and potentially avoid complications such as diabetic ketoacidosis (搜索) (DKA), a serious and potentially life-threatening condition.
Regulatory and Global Expansion Strategy
The collaboration will support clinical validation and regulatory submissions for the new assay across multiple jurisdictions. Regulatory submissions are planned for the U.S. FDA, European IVDR, and other major regulatory bodies worldwide.
Simultaneously, Revvity (搜索) and Sanofi are working to expand access to Revvity's existing research-use-only product. Currently offered as a laboratory-developed test at the CLIA and CAP accredited Revvity Omics laboratory in Pittsburgh, Pennsylvania, the companies plan to validate the assay in additional locations across Revvity's global laboratory network to facilitate worldwide clinical access.
Strategic Implications for Precision Medicine
Dr. Madhuri Hegde, senior vice president and chief scientific officer at Revvity (搜索), emphasized the broader implications of the collaboration: "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 partnership represents a strategic expansion of Revvity (搜索)'s diagnostic capabilities beyond rare diseases into more common autoimmune conditions, potentially establishing new paradigms for population-scale screening programs.
Market Position and Company Background
Revvity (搜索), with 2024 revenue exceeding $2.7 billion and approximately 11,000 employees, serves customers across pharmaceutical and biotech companies, diagnostic laboratories, academia, and government institutions. The company is part of the S&P 500 index and maintains a presence in more than 160 countries worldwide.
The collaboration underscores the growing emphasis on early detection and intervention strategies in autoimmune diseases, potentially setting new standards for how Type 1 diabetes (搜索) is identified and managed in clinical practice.