Currently, there are four Food and Drug Administration (FDA)-approved human papillomavirus (HPV) diagnostic tests for qualitative detection (results that are either positive or negative) in pap smears. These HPV tests have low positive predictive value for whether a patient has early indicators of cervical cancer. This, in turn, can lead to unnecessary additional tests and overly-aggressive treatment strategies, and without doubt, they generate unnecessary patient distress in the event of a false-positive result. A false-negative result, on the other hand, could lead to a failure to detect cervical cancer in sufficient time to stop disease progression.
Army researchers have developed “Molecular Pap” as an in vitro diagnostic device based on comprehensive HPV genotyping and a 3-gene epigenetic profile (ADCY8, CDH8, and ZNF582), which are novel biomarkers for precancerous cellular changes. Molecular Pap has an advantage over traditional tests due to the ability to differentiate between grades of cervical cancer by molecular signature. Another tool developed by this team is called “HPV Discover.” HPV Discover is a molecular method for characterization of the HPV virome to enhance the accuracy of Molecular Pap. Together, Molecular Pap and HPV Discover may be developed as a single or secondary screening test for cervical cancer using the novel biomarkers to indicate disease severity and detect emerging HPV genotypes for which no current diagnostic test exists.
- Early detection capabilities—uses novel biomarkers to detect precancerous cellular changes
- Versatility—may also be applied to oral saliva/throat swabs and other anatomical sites for the detection of HPV infections (currently oral HPV/cancer screening is non-existent)
- Comprehensive HPV genotyping—guides clinicians in selecting the most appropriate therapy based on HPV carcinogenic potential derived from genotyping
- A high-quality, low-cost molecular screening test using easy-to-use reagents with the potential for automation and computerization
- Lead researcher has identified that comprehensive HPV genotyping and a 3-gene epigenetic profile (ADCY8, CDH8, and ZNF582) reveal precancerous cellular changes, and these biomarkers may serve as a molecular classifier of pap smears
- PCT WO2017040491 available for license
- Potential for collaboration with Army researchers