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OncoHealth Presents Studies Supporting Its Protein Biomarker Tests for HPV Evaluation

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Diagnostics company OncoHealth recently presented three studies demonstrating the ability of its protein biomarkers HPV, E6, and E7 to distinguish between insignificant human papillomavirus infections and those that could lead to cervical cancer.

The studies – two oral presentations and a poster – were presented this month at the International Papillomavirus Conference in San Juan, Puerto Rico.

One presentation, given by OncoHealth chief scientific officer Shuling Cheng, demonstrated that E6 and E7 testing applied to samples with abnormal Pap and HPV-positive results had specificity of 76 percent for precancerous cervical disease and three times the positive predictive value of Pap or HPV DNA testing.

According to the company, Pap testing lacks sensitivity for detecting the high-risk HPV that can lead to cervical cancer, while HPV DNA testing lacks specificity.

“Each year, approximately four million women in the US have mildly abnormal cervical cancer screening results that reflect conditions that will typically resolve on their own,” Teresa Darragh, a pathologist at the University of California, San Francisco, and member of OncoHealth's clinical advisor board, said in a statement. "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,” she said.

Additionally, the company presented research showing that it could detect E6 and E7 proteins in single cells and correlated their expression with disease state via flow cytometry.

OncoHealth currently offers both ELISA-based and flow cytometry-based E6 and E7 tests as research-use-only products.

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