Methods and compositions for the detection of cervical disease

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C435S007100, C435S345000, C435S005000

Reexamination Certificate

active

11087227

ABSTRACT:
Methods and compositions for identifying high-grade cervical disease in a patient sample are provided. The methods of the invention comprise detecting overexpression of at least one biomarker in a body sample, wherein the biomarker is selectively overexpressed in high-grade cervical disease. In particular claims, the body sample is a cervical smear or monolayer of cervical cells. The biomarkers of the invention include genes and proteins that are involved in cell cycle regulation, signal transduction, and DNA replication and transcription. In particular claims, the biomarker is an S-phase gene. In some aspects of the invention, overexpression of a biomarker of interest is detected at the protein level using biomarker-specific antibodies or at the nucleic acid level using nucleic acid hybridization techniques. Kits for practicing the methods of the invention are further provided.

REFERENCES:
patent: 5244787 (1993-09-01), Key et al.
patent: 5858683 (1999-01-01), Keesee et al.
patent: 6303323 (2001-10-01), Laskey et al.
patent: 2002/0106685 (2002-08-01), Henning et al.
patent: 2003/0087270 (2003-05-01), Schlegel et al.
patent: 2003/0152993 (2003-08-01), Doeberitz et al.
patent: 2003/0219726 (2003-11-01), Doorbar
patent: 2004/0202996 (2004-10-01), Williams et al.
patent: WO 99/21014 (1999-04-01), None
patent: WO 02/101075 (2002-12-01), None
patent: WO 2004/013632 (2004-02-01), None
Baldwin, P., et al. “Translational Approaches to Improving Cervical Screening,”Nature Reviews, Cancer, 2003, pp. 217-226, vol. 3.
Williams, G. H., et al., “Improved Cervical Smear Assessment Using Antibodies Against Proteins That Regulate DNA Replication,”Proc. Natl. Acad. Sci. USA, 1998, pp. 14932-14937, vol. 95.
Bibbo, M., et al., “Procedure for Immunocytochemical Detection of P16INK4AAntigen in Thin-Layer, Liquid-Based Specimens,”Acta Cytologica, 2002, pp. 25-29, vol. 46(1).
Bibbo, M., et al., “p16INK4AAs an Adjunct Test in Liquid-Based Cytology,”Analytical and Quantitative Cytology and Histology, 2003, pp. 8-11, vol. 25(1).
Bourtsos, E.P., and C.D. Sturgis, “ASC-H Cervicovaginal Cytology's Newest Atypia, A Synoposis of Literature, Recommendations, Ongoing Studies, and Community Practice Experience,”, 2006.
Brake, T., et al., “Comparative Analysis of Cervical Cancer in Women and in a Human Papillomavirus-Transgenic Mouse Model: Identification ofMinichromosome Maintenance Protein 7as an Informative Biomarker for Human Cervical Cancer,”Cancer Research, 2003, pp. 8173-8180, vol. 63.
Chatrath, P., et al., “Aberrant Expression of Minichromosome Maintenance Protein-2 and Ki67 in Laryngeal Squamous Epitherlial Lesions,”British Journal of Cancer, 2003, pp. 1048-1054, vol. 89.
Davies, R.J., et al., “Analysis of Minichromosome Maintenance Proteins as a Novel Method for Detection of Colorectal Cancer in Stool,”The Lancet, 2002, pp. 1917-1919, vol. 359(9321).
Elit, L.M., “Pitfalls in the Diagnosis of Cervical Intraepithtlial Neoplasia 1,”Journal of Lower Genital Tract Disease, 2004, pp. 181-187, vol. 8(3).
Freeman, A., et al., “Minichromosome Maintenance Proteins as Biological Markers of Dysplasia and Malignancy1”Clinical Cancer Research, 1999, pp. 2121-2132, vol. 5.
Gonzalez, M.A., et al., “Minichromosome Maintenance Protein 2 Is a Strong Independent Prognostic Marker in Breast Cancer,”Journal of Clinical Oncology, 2003, pp. 1-8, vol. 21(23).
Hunt, D.P.J., et al., “Early Recurrence of Benign Meningioma Correlates With Expression of Mini-Chromosome Maintenenace-2 Protein,”British Journal of Neurosurgery, 2002, pp. 10-15, vol. 16(1).
Ishimi, Y., et al., “Enhanced Expression of Mcm Proteins in Cancer Cells Derived from Uterine Cervix,”Eur. J. Biochem., 2003, pp. 1089-1101, vol. 270.
Laskey, R., “Initiation of DNA Replication in Normal and Neoplastic Cells,”5thCongress of the European Haematology Association—Educational Book, Session 11—Cell Cycle, 2000, pp. 152-155.
Malinowski, D.P., “Molecular Diagnostic Assays for Cervical Neoplasia: Emerging Markers for the Detection of High-Grade Cervical Disease,”BioTechniques, 2005, pp. 1-8, vol. 38(3).
Murphy, N., et al., “p16INK4Aas A Marker for Cervical Dyskaryosis: CIN and cGIN in Cervical Biopsies and ThinPrep™ Smears,”J. Clin. Pathol., 2003, pp. 56-63, vol. 56.
Nieh, S., et al., “Expression of p16INK4Ain Papanicolaou Smears Containing Atypical Squamous Cells of Undetermined Significance From the Uterine Cervix,”Gynecologic Oncology, 2003, pp. 201-208, vol. 91.
Saqi, A., et al., Overexpression of p16INK4Ain Liquid-Based Specimens (SurePath™ ) as Marker of Cervical Dysplasia and Neoplasia,Diagnostic Cytopathology, 2002, pp. 365-370, vol. 27(6).
Scott, I.S., et al., A Novel Immunohistochemical Method to Estimate Cell-Cycle Phase Distribution in Archival Tissue: Implications for the Prediction of Outcome in Colorectal Cancer,Journal of Pathology, 2003, pp. 187-197, vol. 201.
Whitfield, M.L., “Identification of Genes Periodically Expressed in the Human Cell Cycle and Their Expression in Tumors,”Molecular Biology of the Cell, 2002, pp. 1977-2000, vol. 13.

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Methods and compositions for the detection of cervical disease does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Methods and compositions for the detection of cervical disease, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods and compositions for the detection of cervical disease will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-3751005

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.