Revvity launches CE-IVDR Type 1 diabetes screening kit in Europe for children
The CE-IVDR-certified test is designed to detect three diabetes-associated autoantibodies (AAbs) that can indicate an increased risk of developing T1D.
UK— Revvity has launched its GSP T1D 3plex kit in Europe to support population screening for children at risk of type 1 diabetes (T1D) before symptoms appear.
The CE-IVDR-certified test is designed to detect three diabetes-associated autoantibodies (AAbs) that can indicate an increased risk of developing T1D.
Revvity said the assay is intended for screening programmes seeking to identify children who may develop the disease months or years before clinical symptoms emerge.
The company will initially offer the kit in Europe and other markets that accept CE-marked in vitro diagnostic products.
However, the test has not been cleared by the US Food and Drug Administration (FDA).
The assay uses capillary dried blood spot samples, which are processed on Revvity’s GSP instrument.
The automated workflow combines reagents, instrumentation, and software, building on technology already used in newborn screening programmes.
According to Revvity, identifying at-risk children earlier could enable healthcare providers to monitor them more closely and consider interventions or disease-modifying treatments when appropriate.
Anna Godenhjelm, Revvity’s vice-president and general manager of reproductive health, said the launch expands the company’s child health screening activities.
She added that the company’s experience in newborn screening can be applied to other areas where earlier detection may support healthcare delivery.
Supporting national screening programmes
Revvity developed the kit to meet the needs of emerging national T1D screening programmes.
The product forms part of the company’s broader diabetes portfolio, which covers research, clinical testing and related service models.
The company also plans to present information on its T1D on-site installation and off-site testing services at the European Association for the Study of Diabetes meeting in Milan, Italy.
Revvity developed these services in partnership with Sanofi, reflecting growing interest in screening models that combine testing technologies with supporting laboratory services.
The launch adds another application to Revvity’s established newborn screening infrastructure while expanding the use of automated immunoassay testing in child health.
It also places the company within an emerging screening market focused on identifying T1D risk before the onset of clinical symptoms.
Recent regulatory activity
In May, Revvity received FDA clearance for its total testosterone automated chemiluminescence immunoassay (ChLIA) through its Immunodiagnostic Systems (IDS) subsidiary.
The offering enables direct ChLIA measurements of sex hormone-binding globulin (SHBG), total testosterone, and free testosterone.
Revvity said the tests provide first and second-line diagnostic capabilities for evaluating men with suspected hypogonadism.
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