New methods of diagnosing and monitoring the progression or response to therapy of subjects with autoimmune hepatitis

Available for licensing and commercial development are new methods of diagnosing and monitoring the progression or response to therapy of subjects with autoimmune hepatitis (AIH) by quantitating the frequency and determining the function of autoantigen-specific CD4+ T cells in the peripheral blood with HLA-DRB1*0301 tetramers that display the autoepitopes. The invention identifies the immunogenic peptide regions that are targets of the T-cell immune response in two types of autoimmune hepatitis: (1) anti-SLA (soluble liver antigen)-positive autoimmune hepatitis type 3 and (2) anti-LKM (liver kidney microsomal antigen)-positive autoimmune hepatitis type 2. Upon mapping the immunogenic regions within SLA and P450 2D6 using short, overlapping peptides, the inventors discovered at least four immunogenic peptides within SLA and at least one peptide within P450 2D6 that were recognized by HLA-DRB*0301- restricted T cells. The technology is partially described in Hepatology 2005; 42: 291A-292A.

U.S. Provisional Application No. 60/659,513 filed 07 Mar 2005 (HHS Reference No. E-263-2003/0-US-01) Inventors: Barbara Rehermann (NIDDK) et al.

Licensees sought. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.