Patent ID: 7517662

Claim:
A method for detecting cervical dysplasia, cervical cancer or high grade cervical intraepithelial neoplasia in human cervical samples comprising: preparing a sample solution by solubilizing a human cervical sample in a lysis buffer; determining the level of p16 INK4a within the sample solution and comparing the determined level with the level of p16 INK4a in a normal human cervical sample; determining the level of at least one normalization marker characteristic for the presence of ectocervical or endocervical cells within the sample solution, wherein said normalization marker is gamma-Catenin comprising SEQ ID NO: 1; Ep-Cam comprising SEQ ID NO: 2; E-Cadherin comprising SEQ ID NO: 3; alpha-1 Catenin comprising SEQ ID NO: 4; alpha-2 Catenin comprising SEQ ID NO: 5; beta-Catenin comprising SEQ ID NO: 6; Involucrin comprising SEQ ID NO: 7; or p120 comprising SEQ ID NO: 8; determining a threshold value of the normalization marker by measuring the level of the normalization marker in a control sample solution containing an amount of ectocervical cells or endocervical cells; comparing the level of the at least one normalization marker determined within the sample solution with the threshold value of the normalization marker; and determining that said human cervical sample contains cervical dysplastic cells, cervical cancer cells, or high grade cervical intraepithelial neoplastic cells when the determined level of the at least one normalization marker in the sample solution is elevated above the threshold value and the determined level of p16 INK4a in the sample solution is elevated above the level of p16 INK4a in the normal human cervical sample.