Bayer Corporation

Miles Inc.

Bayer Corporation (formerly Molecular Diagnostics, Inc.)

Daniel U Rabin

Nanibhushan Dattagupta

William J Knowles

Peter M Rae

Edward D Huguenel

Pancreatic islet cell antigens (ICA) that bind with antibodies found in the sera of patients afflicted with insulin-dependent (Type I) diabetes mellitus (IDDM). ICA proteins are expressed by recombinant cloning vehicles comprising DNA inserts isolated from islet cells. Full sequence native ICA proteins, or protein or peptide fragments thereof, can be used in the diagnosis of IDDM and in detecting or blocking human immunoglobulin, T-cells, or B-cells involved in IDDM.

Pancreatic islet cell antigens obtained by molecular cloning

Nucleic acids encoding pancreatic islet cell antigens obtained by

A method for detecting (i) one or more microorganisms or (ii) nucleic acid sequences from a prokaryotic source or an eukaroytic source in an unpurified nucleic acid-containing test sample comprising (a) labeling the nucleic acids in the test sample, (b) contacting, under hybridization conditions, the labeled hybridizable nucleic acid and one or more immobilized hybridizable nucleic acid probes comprising (i) one or more known microorganisms or (ii) sequences from eukaroytic or prokaryotic sources, to form hybridized labeled nucleic acids, and (d) assaying for the hybridized nucleic acids by detecting the label. The method can be used to detect genetic disorders, e.g., sickle-cell anemia.

Assay for nucleic acid sequences in an unpurified sample

Diagnosis of insulin-dependent (Type I) diabetes mellitus (IDDM) by contacting a blood sample from a patient with an immunoreagent comprising epitopes of two or more of glutamic acid decarboxylase (GAD) and the pancreatic islet cell antigens referred to as ICA512 and ICA12. Binding of antibodies present in the blood sample with one or more of such epitopes correlates with IDDM or a potential for developing IDDM. In clinical testing, about 80 percent of sera from newly diagnosed IDDM patients react positively with at least one epitope in a GAD/ICA512 panel. Reactivity with the GAD/ICA512/ICA12 panel is between about 80 and 90 percent. The method is useful in screening patients for pre-IDDM, for distinguishing IDDM from Type II diabetes, and for monitoring therapy.

Diagnosis of IDDM with a panel of immunoreagents

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Branford, CT, United States of America

Daniel U Rabin