Revvity said Thursday it is collaborating with drugmaker Sanofi to develop a test for early-stage screening of Type 1 diabetes.
The aim is to improve patient outcomes through intervention to prevent the natural progression of the disease.
Waltham, Massachusetts-based Revvity plans to develop a four-plex in vitro diagnostic test, designed to detect four autoantibodies that may indicate early stages of Type 1 diabetes. The test, which will use dried blood spot and venous blood specimens, will be based on Revvity’s existing three-plex assay, which is for research use only.
The collaboration will support clinical validation and regulatory submissions for the new assay on Revvity’s GSP instrument. Regulatory submissions are planned for the U.S., Europe and other jurisdictions.
Shirley Gil Parrado, Sanofi’s global head of autoimmune Type 1 diabetes, said in a statement that the expansion of autoantibody testing to commercial platforms such as Revvity GSP “may accelerate the transition to a new clinical standard of care where people with [Type 1 diabetes] are diagnosed as early as possible.”
Revvity and Sanofi will also work together to expand access to Revvity’s research-use-only product that is currently offered as a laboratory-developed test at the Revvity Omics lab in Pittsburgh, Pennsylvania. Revvity plans to validate the assay in additional locations across its global lab network to facilitate worldwide access to the test for clinical use.
Kihealth raises $5M in seed round
Kihealth said Thursday it closed a $5 million seed round that will support the commercial rollout of its first lab-developed test that measures biomarkers of beta cell death, an early indicator of insulin resistance and diseases such as diabetes.
The test, using a simple blood draw, measures pancreatic beta cell viability, enabling identification of high-risk individuals before glucose or A1c abnormalities appear.
