Revvity has announced the expansion of its type 1 diabetes (T1D) program to include a population-scale assay for early detection, developed with support from Sanofi. The company will build on its existing research-use-only (RUO) 3-plex assay to create a new T1D 4-plex in vitro diagnostic (IVD) assay.
Type 1 diabetes is a lifelong, progressive autoimmune condition in which the immune system mistakenly destroys the insulin-producing beta cells of the pancreas. Early identification of T1D can improve patient outcomes by enabling timely intervention to slow disease progression and reduce the risk of serious complications such as diabetic ketoacidosis (DKA). More than 9 million people worldwide live with T1D, and over 500,000 new cases are reported each year—90% in individuals without a family history.
The collaboration between Revvity and Sanofi will support clinical validation and regulatory submissions of the new T1D 4-plex assay for use on Revvity’s high-throughput GSP® instrument. Designed to work with both capillary dried blood spot (DBS) and venous specimens, the GSP® system enables screening at a population scale, representing an important step forward in advancing the standard of care. Regulatory submissions are planned for the U.S. FDA, IVDR, and other global regulatory authorities.
“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.
Alongside this development, Revvity and Sanofi are also working to broaden access to Revvity’s current RUO product. The assay is already available as a laboratory-developed test (LDT) at the CLIA- and CAP-accredited Revvity Omics laboratory in Pittsburgh, PA. Revvity now plans to validate the test across additional laboratories in its global network, increasing worldwide access for clinical use.
“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,” said 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.”