US 11,885,802 B2
Method for diagnosing primary biliary cirrhosis (PBC) using novel autoantigens
Mark J. Lim, Reading, MA (US); Heather P. Ostendorff, Framingham, MA (US); Kenneth J. Rothschild, Newton, MA (US); and Donald B. Bloch, Newton, MA (US)
Assigned to AMBERGEN, INC., Watertown, MA (US); and MASSACHUSETTS GENERAL HOSPITAL, Boston, MA (US)
Filed by Ambergen, Inc., Watertown, MA (US); and Massachusetts General Hospital, Boston, MA (US)
Filed on Mar. 24, 2017, as Appl. No. 15/469,350.
Application 15/469,350 is a division of application No. 14/318,498, filed on Jun. 27, 2014, abandoned.
Application 14/318,498 is a continuation of application No. 13/500,411, granted, now 8,852,956, issued on Oct. 7, 2014, previously published as PCT/US2010/051475, filed on Oct. 5, 2010.
Claims priority of provisional application 61/248,768, filed on Oct. 5, 2009.
Prior Publication US 2017/0307607 A1, Oct. 26, 2017
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/543 (2006.01); G01N 33/564 (2006.01); G01N 33/68 (2006.01)
CPC G01N 33/564 (2013.01) [G01N 33/6893 (2013.01); G01N 2333/47 (2013.01); G01N 2800/085 (2013.01)] 10 Claims
 
1. A manufacture comprising:
(a) at least a first target autoantigen selected from the group consisting of a target antigen of ketch-like 12 comprising the amino acid sequence of SEQ ID NO:12 and a homolog thereof and/or at least a second target autoantigen selected from the group consisting of a target autoantigen of hexokinase 1 comprising the amino acid sequence of SEQ ID NO:1 and a homolog thereof, wherein each of the at least first and/or second target autoantigen is immobilized on a solid support,
(b) a labeled anti-immunoglobulin antibody; and
(c) a positive control for primary biliary cirrhosis (PBC), wherein the positive control comprises an autoantibody with known titer for at least first and/or second target autoantigen of (a) wherein the positive control autoantibody is capable of binding the immobilized at least first and/or second target autoantigen (a),
wherein the kelch-like 12 homolog comprise the amino acid sequence selected from the group consisting of SEQ ID NOs:13,14,15,16,17 and 18, and wherein the hexokinase 1 homolog comprise the amino acid sequence selected from the group consisting of SEQ ID NOs:7, 8, 9, 10 and 11.