Revvity and Sanofi Collaborate on Program to Revolutionize Early Detection of Type 1 Diabetes

Type 1 diabetes (T1D) is a lifelong autoimmune condition in which the immune system destroys the pancreas’s insulin-producing beta cells, leading to dependence on insulin therapy. Early detection is critical for improving outcomes, as timely intervention can delay disease progression and prevent severe complications such as diabetic ketoacidosis (DKA). Despite its prevalence, over 90% of cases occur without a family history, making population-level screening essential. Now, a new diagnostic program aims to revolutionize the early detection of T1D.

Revvity (Waltham, MA, USA) has announced a program to expand its T1D offering, including a population-scale assay for early detection, with support from Sanofi (Paris, France). The collaboration supports clinical validation and regulatory submissions of the new T1D 4-plex assay on Revvity’s GSP instrument using capillary dried blood spot (DBS) and venous specimens.

Image: The collaboration supports clinical validation and regulatory submissions of the new T1D 4-plex assay on Revvity’s GSP instrument (Photo courtesy of Revvity)

The GSP instrument’s high throughput capability enables population-level screening for early-stage T1D in clinical practice, an important advance in the evolution of the standard of care. Regulatory submissions are planned for the U.S. FDA, IVDR, and other major jurisdictions. Revvity and Sanofi are also collaborating to expand access to Revvity’s existing RUO product. Currently offered as an LDT at the US CLIA and CAP-accredited Revvity Omics laboratory, Revvity will work to validate the assay in additional locations across its global laboratory network to facilitate worldwide access to the assay for clinical use.

“The expansion of autoantibody testing from research-use towards convenient, affordable, high-quality and high-throughput 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.

“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,” added Dr. Madhuri Hegde, senior vice president and chief scientific officer at Revvity. “This collaboration reinforces the value of collaboration across biotech, improving patient outcomes by ensuring assays are available to identify the people who would benefit from therapeutics developed by the pharmaceutical industry.”

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