WALTHAM, Mass.– Revvity, Inc. (NYSE: RVTY) today announced a major initiative to expand its Type 1 diabetes (T1D) offering with the goal of revolutionizing early detection. Backed by Sanofi (EURONEXT: SAN and NASDAQ: SNY), the program includes the development of a new population-scale in vitro diagnostic (IVD) assay and the broader availability of a lab-developed test (LDT) through the Revvity Omics laboratory network.
The company plans to introduce a T1D 4-plex IVD assay built on its existing research-use-only (RUO) 3-plex assay. T1D is a lifelong autoimmune disease in which the immune system destroys insulin-producing beta cells in the pancreas. Early detection can give patients and caregivers the opportunity to intervene before the disease progresses and serious complications, like diabetic ketoacidosis (DKA), arise. More than 9 million people live with T1D globally, with over 500,000 new cases diagnosed each year—90% of which occur in individuals without a family history of the disease.
The 4-plex assay will be clinically validated and submitted for regulatory approval in the U.S., Europe under the IVDR, and other global markets. It will run on Revvity’s high-throughput GSP® instrument using both dried blood spot (DBS) and venous samples, enabling widespread clinical screening for early-stage T1D. “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.
In addition, Revvity and Sanofi are working to broaden access to Revvity’s existing RUO product. Currently offered as a lab-developed test through the CLIA- and CAP-accredited Revvity Omics lab in Pittsburgh, the assay will be validated in additional labs across Revvity’s global network to make it more accessible for clinical use worldwide.
“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.”
