HPV E6, E7 mRNA assay and methods of use thereof
AssigneeIncellDx, Inc.
InventorBruce K. Patterson
Life of this patent
Estimating the term…
Abstract
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.
Claims20
A method comprising:
- contacting a specimen of cervical cells with HPV E6, E7 mRNA specific oligonucleotides;
- and
- determining the percentage of cervical cells in the specimen having E6, E7 mRNA copies above a positive pre-determined cut-off point, wherein the cut-off point is 100 copies of HPV E6, E7 mRNA per cell.
A method comprising:
- contacting a specimen of cervical cells with HPV E6, E7 mRNA specific oligonucleotides;
- and
- determining the percentage of cervical cells in the specimen having E6, E7 mRNA copies above a positive pre-determined cut-off point, wherein the cut-off point is 200 copies of HPV E6, E7 mRNA per cell.
A method of screening a patient for malignant transformation of cervical cells, the method comprising:
- labeling a specimen of cervical cells from the patient with HPV E6, E7 mRNA specific oligonucleotides;
- and
- quantifying expression of E6, E7 mRNA in the cells to screen the patient for malignant transformation of the cervical cells in less than three hours, wherein the method comprises determining the percentage of cervical cells in the specimen having E6, E7 mRNA copies above a positive pre-determined cut-off point and the cut-off point is 100 copies of HPV E6, E7 mRNA per cell.
A method of screening a patient for malignant transformation of otherwise normal appearing cervical cells, the method comprising:
- labeling a specimen of otherwise normal appearing cervical cells from the patient with HPV E6, E7 mRNA specific oligonucleotides;
- and
- determining the percentage of cervical cells in the specimen having E6, E7 mRNA copies above a positive pre-determined cut-off point to screen the patient for malignant transformation of the otherwise normal appearing cervical cells in less than three hours, wherein the cut-off point is 100 copies of HPV E6, E7 mRNA per cell.
Dependencies are inferred from the claim text.