Revvity Launches IVDR-Certified Solution for Early Detection of Type 1 Diabetes

Original from: business wire

Revvity, Inc. (NYSE: RVTY) today announced the launch of the GSP® T1D 3plex kit, a fully automated, CE-IVDR-certified, multiplex autoantibody (AAb) detection solution to enable population-wide screening programs that identify children at risk of developing type 1 diabetes (T1D) before symptoms appear.

A critical public health challenge, T1D is often only identified after significant beta-cell damage has occurred, presenting first as a life-threatening diabetic ketoacidosis (DKA) episode. Using capillary dried blood spots (DBS) for simple, scalable sample collection, the 3-plex assay is processed on Revvity’s GSP®instrument, a high-throughput, trusted platform in newborn screening. This end-to-end workflow, which includes reagents, instrumentation, and software, can detect at-risk individuals months or years before symptoms, enabling early intervention and disease-modifying treatment.

"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 GSP T1D 3plex kit is designed to meet the needs of emerging national T1D screening programs, providing a reliable, regulatory-compliant solution. It is the latest addition to Revvity's expanding diabetes portfolio, which spans research, clinical testing and service models.

At the European Association for the Study of Diabetes (EASD) in Milan, Italy, from September 28 – October 2, Revvity will be presenting details on both its T1D on-site installation and off-site testing service solutions developed in collaboration with Sanofi.

The GSP T1D 3plex kit will initially be available in Europe and all markets that accept CE IVD-marked products. The GSP T1D 3plex is not a U.S. Food and Drug Administration (FDA)-cleared device.

Source: Revvity Launches IVDR-Certified Solution for Early Detection of Type 1 Diabetes