Patent ID: 7361460

Claim:
A method of categorizing HPV-induced cervical neoplasia and cancer in a subject, comprising: (a) detecting a presence or an expression of HPV nucleic acid levels in a subject sample; (b) detecting a protein marker expression in the subject sample, wherein at least one protein marker is selected from the group consisting of: PCNA, MIB-1, Ki-67, cdc6, mcm2, and mcm5, and at least one protein marker is selected from the group consisting of: p16, p14, and p21; (c) determining a Molecular Grade of the subject sample, wherein Molecular Grade 0 is characterized by an absence of high risk HPV DNA or RNA; Molecular Grade I is characterized by a presence of high-risk HPV DNA or RNA and an absence of protein marker expression, and Molecular Grade II is characterized by a presence of high risk HPV DNA or RNA and a presence of protein marker expression; and (d) categorizing the HPV-induced cervical neoplasia and cancer into Molecular Grade 0, Molecular Grade I, or Molecular Grade II in the subject, wherein the subject sample is Molecular Grade 0 for: about 0-18% of a population having high grade squamous intraepithelial lesion (HSIL; suspect cervical intraepithelial neoplasia CIN3+); about 1-12% of a population having high grade squamous intraepithelial lesion (HSIL; suspect CIN2-3); about 8-23% of a population having low grade squamous intraepithelial lesion (LSIL; suspect CIN1); about 41-63% of a population having atypical squamous cells of undetermined significance (ASCUS); and about 85-97% of a population within normal limits (WNL).