Revvity, Inc. 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. Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay.
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.
“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 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.
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