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OncoHealth's HPV E6/E7 Assays Help Differentiate Cervical Disease From Clinically Insignificant HPV Infections

Posted on: December 16, 2012
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OncoHealth Corporation, a protein biomarker diagnostics company, has announced three new studies demonstrating the effectiveness of assays using its proprietary HPV E6 and E7 biomarkers to distinguish clinically meaningful cervical disease from insignificant HPV infections. The findings were presented this month at the 28th International Papillomavirus Conference, held in San Juan, Puerto Rico. The studies, presented in two oral presentations and a poster, suggest 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, while testing for high-risk human papillomavirus (HPV), the cause of cervical cancer, lacks specificity. 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.

In one presentation, entitled "The Potential Use of Direct E6E7 cELISA for Triage of Patients with Abnormal Test Results," Shuling Cheng, Ph.D., Chief Scientific Officer at OncoHealth, presented data showing that, when applied to samples with abnormal Pap and HPV-positive test results, an E6E7 whole-cell ELISA assay demonstrated a specificity of 76% 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 1700 liquid-based abnormal cervical cytology samples, were based on an initial 158 cases with known histology results from patients who had biopsies.

"Each year, approximately four million women in the U.S. have mildly abnormal cervical cancer screening results that reflect conditions that will typically resolve on their own," said Teresa M. Darragh, M.D., professor of pathology, department of pathology at the University of California, San Francisco (UCSF). "Because clinicians do not know which cases will spontaneously resolve, most of these women undergo inefficient repeat testing or invasive, costly procedures. The findings suggest the potential for the E6E7 cELISA assay to help millions of women avoid unnecessary procedures each year, while focusing resources on the women who will benefit the most from intervention."

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 1500 liquid-based cervical cytology samples.

"These new data further demonstrate the potential of OncoHealth's patented biomarkers and technology to improve cervical cancer screening and diagnosis," said Karen Smith McCune, M.D. Ph.D., director of the dysplasia clinic at UCSF; John Kerner Endowed Chair of Gynecologic Oncology; and a professor at UCSF. "In particular, among women with abnormal screening results, OncoHealth's technology may help select which women can avoid unnecessary additional procedures and which women will benefit from them, potentially improving patient outcomes while reducing healthcare costs."

" While cervical cancer mortality rates have decreased substantially over the last few decades due to early detection and intervention, over-diagnosis of minimal abnormalities and over-treatment are critical problems leading to unnecessary anxiety, pain, expense, and inconvenience. The widely used Pap screening test (over 50 million tests per year in the U.S.) is limited by low sensitivity and high false-positive results. More recently added sensitive HPV DNA tests (about 10 million tests per year in the U.S.) can detect the presence of HPV, but cannot differentiate between pre-cancerous lesions and self-limiting infection. For women undergoing cervical cancer screening today, approximately four million every year have an abnormal Pap test and, of these, only about 400,000 (10%) actually have true pre-cancerous disease that could benefit from invasive and expensive procedures (colposcopy and/or biopsy/histology). Thus, in the U.S., approximately more than three million women each year are over-diagnosed and/or over-treated. OncoHealth's test can potentially substantially reduce unnecessary procedures and associated healthcare costs.

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