Advanced Screening Method for Early Detection of Type 1 Diabetes Exceeds Traditional Standards
Researchers from Lund University and Enable Biosciences announced significant findings from their latest collaborative study, revealing the superior performance of the automated multiplex Antibody Detection by Agglutination-PCR (ADAP) technology over traditional Radiobinding Assays (RBA) in identifying early stages of Type 1 Diabetes (T1D). The results, published in eBioMedicine, emphasize the potential for early detection and intervention in T1D.
The paper may be accessed via https://www.sciencedirect.com/science/article/pii/S2352396424001798.
The study, part of the Swedish Better Diabetes Diagnosis (BDD) initiative, compared the efficacy of the ADAP method against the standard RBA in a comprehensive analysis of Stage 3 T1D among 1-10-year-old children. Samples from over 2500 T1D patients were compared to an equal number of healthy controls tested to determine the levels of four islet autoantibodies. ADAP technology not only met but exceeded the sensitivity and specificity achieved by traditional RBAs, with specificity of 98% and a sensitivity of 92% using standardized thresholds, compared to 98% specificity and only 71% sensitivity observed with RBA.
"By integrating ADAP into routine screenings of capillary blood samples, we can detect and diagnose non-symptomatic type 1 diabetes earlier, improving patient outcomes and reducing the incidence of severe complications like diabetic ketoacidosis," said Professor Åke Lernmark, the study's lead researcher at Lund University. "This technology also facilitates large-scale screenings with its high throughput capabilities and minimal blood sample requirements."
ADAP's effectiveness in dual-site automated analysis in the United States and Sweden underscores its reliability and adaptability across different laboratory settings. ADAP's capacity to handle micro-volume samples efficiently makes it particularly suited for pediatric screenings.
"This breakthrough is a stepping stone towards global efforts in T1D prevention and management," added Dr. David Seftel, CEO of Enable Biosciences.
The study was generously supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust to Lund University and by EU Interreg ÖKS for the DiaUnion project.
About Enable Biosciences Inc.:
Enable Biosciences Inc. is a leading diagnostic healthcare company in South San Francisco. Enable is dedicated to advancing innovative diagnostic solutions that improve patients’ lives by detecting disease when it matters most. For more information, visit www.enablebiosciences.com.
About Lund University:
Lund University is one of the world's top universities. The research was conducted at Lund University Clinical Research Center (CRC) at Skåne University Hospital in Malmö, Sweden by researchers from the Department of Clinical Sciences Malmö at Lund University.