Revvity has announced a programme for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Sanofi, as well as a new laboratory-developed test to expand clinical testing for early-stage disease screening.
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 nine 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 (pictured) 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 US 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 a laboratory-developed test (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.
“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. This 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.”