US 7,510,838 B2
Methods and compositions for the detection of cervical disease
Timothy J. Fischer, Raleigh, N.C. (US); Douglas P. Malinowski, Hillsborough, N.C. (US); Adriann J. Taylor, Durham, N.C. (US); and Margaret R. Parker, Raleigh, N.C. (US)
Assigned to TriPath Imaging, Inc., Burlington, N.C. (US)
Filed on Sep. 14, 2006, as Appl. No. 11/521,144.
Application 11/521144 is a continuation of application No. 11/087227, filed on Mar. 23, 2005, granted, now 7,157,233.
Claims priority of provisional application 60/556495, filed on Mar. 24, 2004.
Prior Publication US 2007/0009885 A1, Jan. 11, 2007
Int. Cl. C12Q 1/68 (2006.01)
U.S. Cl. 435—6  [435/345] 14 Claims
 
1. A method for diagnosing high-grade cervical disease in a patient independent of the patient's HPV infection status, the method comprising:
a) obtaining a body sample from the patient;
b) contacting the sample with at least three antibodies, wherein each of the antibodies specifically binds to a nuclear biomarker protein that is selectively overexpressed in high-grade cervical disease, wherein a first and a second antibody specifically bind to the biomarker protein MCM2, and wherein a third antibody specifically binds to the biomarker protein Topo2A; and,
c) detecting binding of the antibodies to the biomarker proteins MCM2 and Topo2A to determine if the biomarker proteins are overexpressed in the sample, and thereby diagnosing high-grade cervical disease in the patient.