Waltham, Mass. — Revvity has launched a new automated screening test designed to identify children at risk of developing type 1 diabetes before symptoms appear.
The company said its GSP T1D 3plex kit is a CE-IVDR-certified multiplex autoantibody detection test designed for use in large-scale screening programs. The test uses dried blood spot samples and runs on Revvity’s GSP instrument, a high-throughput platform already used in newborn screening.
Type 1 diabetes is often diagnosed only after significant damage to insulin-producing beta cells has occurred, and in some cases first presents as diabetic ketoacidosis. Revvity said its new screening system is designed to detect at-risk individuals months or years before symptoms develop.
“The launch of the GSP T1D 3plex kit marks an important step forward for Revvity’s expansion into child health screening,” said Anna Godenhjelm, Vice President and General Manager of Reproductive Health at Revvity. “This milestone demonstrates how our expertise in newborn screening can be leveraged to advance earlier detection in new areas of healthcare.”
The system includes reagents, instrumentation and software and is designed to support emerging national type 1 diabetes screening programs.
The launch also expands Revvity’s diabetes portfolio, which includes research tools, clinical testing and service-based screening models.
Revvity plans to present details on its type 1 diabetes on-site testing and off-site testing services at the European Association for the Study of Diabetes meeting in Milan from Sept. 28 through Oct. 2. The off-site testing service was developed in collaboration with Sanofi.
The GSP T1D 3plex kit will initially be available in Europe and other markets that accept CE IVD-marked products. The test has not been cleared by the U.S. Food and Drug Administration.
