Provided is an HPV E6, E7 mRNA assay, referenced herein as the "In Cell
HPV Assay," that is capable of sensitive and specific detection of normal
cervical cells undergoing malignant transformation as well as abnormal
cervical cells with pre-malignant or malignant lesions. The In Cell HPV
Assay identifies HPV E6, E7 mRNA via in situ hybridization with
oligonucleotides specific for HPV E6, E7 mRNA and quantitates the HPV E6,
E7 mRNA via flow cytometry. The In Cell HPV Assay can be carried out in
less than three hours directly from liquid-based cervical ("LBC")
cytology specimens. The In Cell HPV Assay provides an efficient and
highly sensitive alternative to the Pap smear for determining abnormal
cervical cytology.