HPV E6/E7 assays could differentiate cervical disease from clinically insignificant HPV infections


OncoHealth has reported three new studies demonstrating the effectiveness of assays using its proprietary human papillomavirus (HPV) E6 and E7 biomarkers to distinguish clinically meaningful cervical disease from insignificant HPV infections. The findings were presented at the 28th International Papillomavirus Conference, being held from 30th November to 6th December, in San Juan, Puerto Rico. The studies suggested that the company's biomarkers and technology platform can be used to develop tests that may help clinicians better determine which women with abnormal cervical cancer screening results require additional testing or procedures.

Previous studies have demonstrated that Pap testing lacks sensitivity and specificity, while testing for high-risk HPV, the cause of cervical cancer. As a result, millions of women with abnormal screening results undergo unnecessary repeat testing and/or additional procedures, such as colposcopy and biopsy, each year. OncoHealth's tests are based on E6 and E7 oncoproteins, which are scientifically known to be associated with progression of HPV infection to cervical cancer.

The presentation, entitled "The Potential Use of Direct E6E7 cELISA for Triage of Patients with Abnormal Test Results", showed that, when applied to samples with abnormal Pap and HPV-positive test results, an E6E7 whole-cell ELISA assay demonstrated a specificity of 76 per cent for pre-cancerous cervical disease (CIN3). The positive predictive value (PPV) of the E6E7 cELISA assay for CIN3 was three times greater than the PPV of Pap or HPV DNA testing. The findings, part of an ongoing study involving more than 1,700 liquid-based abnormal cervical cytology samples, were based on an initial 158 cases with known histology results from patients who had biopsies.

Additionally, in a study entitled, "Detection of HPV-E6E7 Oncoproteins in Cytology Samples Using Flow Cytometry Assay", researchers demonstrated the ability of OncoHealth's technology to accurately detect E6 and E7 oncoproteins in single cells and correlate their expression levels with disease state using a flow cytometry testing platform. The study involved more than 1,500 liquid-based cervical cytology samples.

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Sector: Medical Devices
Geography: Puerto Rico, United States