The kit was developed to address the requirements of emerging national T1D screening programmes. Credit: ANDREI ASKIRKA/Shutterstock.com.

Revvity has launched the GSP T1D 3plex kit, a fully automated, CE-IVDR-certified test intended to support population screening programmes for children at risk of developing type 1 diabetes (T1D) months or years before symptoms emerge.

The multiplex autoantibody (AAb) detection solution will initially be available in Europe and in markets that accept CE IVD-marked products. It is not cleared by the US Food and Drug Administration (FDA).

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The assay uses capillary dried blood spot (DBS) samples and is processed on Revvity’s GSP instrument. The platform is used in newborn screening, and the workflow involves reagents, instrumentation and software.

Earlier identification is expected to support early intervention and disease-modifying treatment.

Revvity vice-president and reproductive health general manager Anna Godenhjelm said: “The launch of the GSP T1D 3plex kit marks an important step forward for Revvity’s expansion into child health screening.

“This milestone demonstrates how our expertise in newborn screening can be leveraged to advance earlier detection in new areas of healthcare.”

The kit was developed to address the requirements of emerging national T1D screening programmes. It forms part of Revvity’s diabetes portfolio, which includes research, clinical testing and service models.

The company plans to present information on its T1D on-site installation and off-site testing services, developed in partnership with Sanofi, at the European Association for the Study of Diabetes meeting in Milan, Italy.

In May, Revvity received clearance from the FDA for its total testosterone automated chemiluminescence immunoassay (ChLIA) via its Immunodiagnostic Systems (IDS) subsidiary.

This offering allows for direct ChLIA measurements of SHBG, total testosterone, and free testosterone, delivering key first-line and second-line diagnostic capabilities for identifying suspected hypogonadism in men.