Methods for diabetes susceptibility assessment in...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

Reexamination Certificate

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C435S007400, C436S506000, C436S518000

Reexamination Certificate

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06960448

ABSTRACT:
Assays for identifying human patients at risk for developing insulin-dependent diabetes mellitus rely on detection of autoantibodies to a 38 kD autoantigen present in pancreatic β-cells in patient sera. It has been found that autoantibodies to this particular autoantigen developed in patients well before clinical onset of the disease in a significant subpopulation of prediabetic patients. Useful assays will frequently combine detection of autoantibodies to the 38 kD autoantigen with detection of other known markers of IDDM, such as autoantibodies to a 64 kD autoantigen (glutamic acid decarboxylase).

REFERENCES:
patent: 5674692 (1997-10-01), Baekkeskov et al.
patent: 6316209 (2001-11-01), Baekkeskov et al.
patent: WO 91/17186 (1991-11-01), None
patent: WO 92/04632 (1992-01-01), None
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Roep et al., T-cell reactivity to 38 kD insulin-secretory-granule protein in patients with recent-onset type 1 diabetes. Lancet 337:1439-1441, 1991.
Ko et al., Studies on autoimmunity for initiation of Beta-cell destruction. VIII. Pancreatic Beta-cell dependent autoantibody to a 38 kilodalton protein precedes the clinical onset of diabetes in BB rats. Diabetologia 34:548-554, 1991.
Deaizpurua et al., “A 64kDA Antigen/Glutamic Acid Decarboxylase (GAD) in Fetal PIG Pro-Islets: Co-Precipitation with a 38 kDA Protein and Recognition by T Cells in Human at Risk for Insulin-Dependent Diabetes” Hournal of Autoimmunity 5:759-770 (1992).
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Baekkeskov et al., “Identification of the 64K autoantigen in insulin-dependant diabetes as the GABA-synthesizing enzyme glutamic acid decarboxylase,”Nature, 347:151-156 (1990).
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