| 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.
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