New Data Suggest OncoHealth's HPV E6 and E7 Tests Can Distinguish Cervical Disease From Clinically Insignificant HPV Infection

SAN JOSE, Calif., Sept. 21, 2011 /PRNewswire/ -- OncoHealth Corporation, a protein biomarker diagnostics company, today announced new study data showing that the company's proprietary HPV E6 and E7 oncoprotein assays correlated with cervical disease grade and may distinguish cervical disease or cervical cancer from clinically insignificant HPV infection. These new data were shared in presentations at the 27th International Papillomavirus Conference, held this week in Berlin, Germany. The oral and poster presentations suggest that the company's technology platform may be appropriate for high-throughput ELISA and flow cytometry testing of cervical cytology samples. When used in cervical cancer screening and diagnosis, the company's assays may provide information that would enable physicians to better determine which women can avoid additional testing and/or procedures.

In a presentation entitled, "High-Throughput Whole-Cell ELISA for Detection of HPV-E6 in Cytology Samples," Shuling Cheng, Ph.D., Chief Scientific Officer at OncoHealth, and other researchers presented data showing that a high-throughput ELISA assay using OncoHealth's technology detected HPV E6 oncoprotein expression levels that were correlated statistically with cervical disease and cancer. HPV E6 and E7 are oncoproteins scientifically known to be associated with the progression of HPV infection to cancer and offer more specific information than testing for high-risk HPV DNA. The findings were based on analysis of more than 800 liquid-based, clinical cervical cytology samples. The study involved researchers from leading institutions, including the American Society for Clinical Pathology Institute, the University of California, San Francisco, and the Laboratory Corporation of America.

"In our study, we developed a new assay with the potential to provide a robust tool to distinguish women who have significant HPV infections -- cervical pre-cancer with the potential to progress to cancer -- from those women with benign infections that will likely resolve on their own," said Teresa M. Darragh, M.D., Professor of Clinical Pathology, Department of Pathology at the University of California, San Francisco, and one of the researchers involved in the study. "The availability of such information could potentially help millions of women avoid unnecessary procedures and treatment each year."

"HPV testing identifies women infected with the virus that can lead to cervical cancer, but cannot determine which women have infections that will progress. These limitations have led to inefficient, repeated testing and over-referral for colposcopy and biopsy," said Karen Smith-McCune, M.D., Ph.D., Professor and Director of the Dysplasia Clinic at the University of California, San Francisco, and one of the study's authors. "Our findings demonstrate that this technology could potentially increase the efficiency of cervical cancer screening and diagnosis."

Additionally, in a poster presentation entitled, "Flow Cytometry Assay Detecting HPV-E6/E7 Oncoproteins in Cytology Samples," researchers shared data demonstrating the ability of OncoHealth's technology to accurately detect HPV E6 and E7 oncoproteins in single cells and correlate their expression levels with disease state using a flow cytometry testing platform. The study involved 166 liquid-based cervical cytology samples and showed that the level of fluorescent intensity increased with increasing severity of biopsy-proven cervical dysplasia.

"These new data add to the growing body of evidence showing the potential of our patented biomarkers and technology to be applied to tests that can potentially improve cervical cancer screening and diagnosis for millions of women each year," said Winnie Wan, Ph.D., Chief Executive Officer of OncoHealth. "The clinical performance of our technology has now been demonstrated on four different testing platforms,  including immunohistochemistry (IHC) and immunocytochemistry (ICC), enzyme immunoassay (ELISA) and flow cytometry, which underscores the robustness of our technology. By the later part of the year, we intend to begin making our technology available via analyte specific reagents to CLIA laboratories."

While cervical cancer mortality rates have decreased substantially over the last few decades due to early detection and intervention, over-diagnosis 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. The more recently added sensitive HPV DNA tests (about 10 million tests per year) 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 600,000 (15%) actually have true pre-cancerous disease and could benefit from invasive and expensive procedures (colposcopy and/or biopsy). Thus, in the U.S., approximately more than three million women each year are over-diagnosed and/or over-treated.

About OncoHealth

OncoHealth Corporation plans to commercialize novel, proprietary screening and diagnostic tests for cervical cancer and other cancers associated with the human papillomavirus. The company's technology platform includes proprietary biomarkers and robust detection technology that can enable the development of easy-to-use, high-throughput and cost-competitive assays.  OncoHealth is based in San Jose, Calif. For more information, please visit www.oncohealthcorp.com.  

SOURCE OncoHealth Corporation