Revvity Expands Type 1 Diabetes Portfolio With Sanofi Support; To Develop T1D 4-Plex IVD Assay Based On Existing RUO 3-Plex Assay

Initiative spans an IVD assay and a new Revvity Omics lab-developed test to expand clinical testing for early-stage disease screening

Revvity, Inc. (NYSE:RVTY) today announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Sanofi (NASDAQ:SNY). Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay.

T1D is a lifelong, progressive autoimmune condition that occurs when the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Early detection of T1D enables options for patients and caregivers to improve outcomes through intervention to prevent the natural progression of the disease and complications such as diabetic ketoacidosis (DKA). Over 9 million people worldwide live with T1D with more than 500,000 new cases diagnosed each year—90% without a family history.

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. 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.

In parallel, Revvity and Sanofi are also collaborating to expand access to Revvity's existing RUO product. Currently offered as an LDT at the CLIA and CAP accredited Revvity Omics laboratory in Pittsburgh, PA, 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.