Novel Method for Cervical Cancer Screening
JHU REF: C13649
Invention novelty:
This invention is a diagnostic method for diagnosis and progression monitoring of premalignant lesions in cervical cancer via DNA methylation and quantitative Methylation Specific PCR (qMSP).
Value Proposition:
Currently, the primary diagnostic for cervical cancer is a Papanicolaou (Pap) smear. If the Pap smear is positive; HPV genotyping diagnostics, a colposcopy, and/or a biopsy are used as confirmation. However, Pap smears and HPV infection tests do not distinguish between lesions that will progress to an invasive carcinoma and those that will not. This current technology is advantageous as it is;
- Non-invasive, which reduces the risk of infection or inflammation.
- Will potentially aid in the clinical management of HPV-positive/Pap-negative women.
- It is potentially a more sensitive test to monitor progression from no malignancy to cervical cancer.
- Can aid in the identification of patients who will progress to cervical cancer.
Technical Details:
Researchers at Johns Hopkins identified a panel of methylated human papilloma virus (HPV) and human genes that can discriminate between cervical intraepithelial neoplasia, grade 2 or higher (CIN2+) and normal/CIN1 patients in liquid prep samples and in Transrenal DNA (TrDNA) isolated from urine.
The panel of viral and host gene methylation markers identified by the researchers may be used as a reflex test in liquid prep to triage high risk HPV positive women into colposcopy, or as a screening and triage test in TrDNA in combination with the researchers high risk HPV test. The invention can also be developed into a personalized cervical cancer test in which the host and HPV methylome of young women or receivers of the HPV vaccine DNA is sequenced. The methylation level of an individual’s panel of high risk genes can be identified and tested in urine periodically during the course of that individual’s life.
Looking for Partners: To develop and commercialize the technology as the primary prognostic/diagnostic for cervical cancer.
Stage of Development: Pre-Clinical
Data Availability: Under CDA/NDA
Patent Status: pending
Publication(s)/Associated Cases: none at this time
Categories: Diagnostic
Keywords: cervical cancer, HPV, papillomavirus, transrenal, qPCR, genome sequencing, noninvasive, Methylation, qMSP
