Major Breakthrough in the Fight against Cervical Cancer Presented at EUROGIN in Prague

MENLO PARK, California, July 11, 2012 /PRNewswire/ -- Approximately 510,000 cases of cervical cancer are reported each year around the world, making it the second leading cause of cancer deaths among women worldwide.  Yet, cervical cancer is treatable — and often curable — when detected in its early stages.  IncellDx, a California-based research company, has introduced a new testing methodology called HPV OncoTect that measures a woman's increased risk for future development of cervical cancer with remarkable accuracy. 

Virtually all cases of cervical cancer are caused by specific types of human papillomavirus (HPV) and current testing methods detect only the presence and type of HPV infection and cellular abnormalities caused by the virus. OncoTect goes further to not only detect cellular transformation caused by persistent HPV infection, but also quantify the cancer causing genes found in the cells that is the necessary precursor to the development of cervical cancer.

The new test was the focus of two independent clinical studies that sought to compare the performance of OncoTect against other commercially available tests. The results of these studies is being introduced to the international medical community at EUROGIN 2012, one of the largest global forums for the review of current scientific developments in the field of cervical cancer and human papillomavirus related diseases.

The first study, conducted in Greece, evaluated the specificity of HPV OncoTect against the commonly utilized HPV DNA test.  After analyzing 4,000 cervical cell samples, researchers found that OncoTect significantly increases specificity for high grade cervical disease compared to HPV DNA genotyping while maintaining the sensitivity of commonly used HPV DNA tests.  If a test has high specificity, a positive result from the test means a high probability of the presence of disease.

Italian researchers conducted a second study to compare OncoTect with a competitive product called NucliSens EasyQ . Their results showed that while NucliSens EasyQ did identify the presence of cancer causing genes, the clinical significance of the findings are limited because it does not measure the extent of the cellular changes that led to disease in addition to showing lower sensitivity compared to OncoTect.

IncellDx also has been invited to present new data at EUROGIN 2012 on the next generation of the HPV OncoTect test – called OncoTect 3Dx, which uses the newest cancer screening technology that incorporates morphology of slides with molecular biomarkers in a single high throughput assay thus eliminating ambiguous pap results. The new technology further improves the test's ability to distinguish between benign infection and the cell changes that can lead to the development of cancer. In addition, this technology does not rely on a glass slide, thus reducing the cost and time taken to complete the test significantly.

More than 2,000 healthcare professionals are attending EUROGIN 2012, held this year in Prague, Czech Republic, from July 8-11.  The event seeks to accelerate the translation of scientific discoveries into day-to-day medical practice.

Until now, HPV diagnostic testing could identify only the presence and type of HPV, but could not predict if the infection would clear up or likely progress to cancer. OncoTect is an important diagnostic tool, helping doctors know when more aggressive testing is needed – and also to feel confident when "wait and see" is the best approach. Traditionally, when a woman tests positive for high risk HPV infection, her doctor performs a colposcopy, a magnified examination of the cervix in which biopsy samples are taken.  OncoTect will help determine when colposcopies are medically unnecessary.

OncoTect is an important breakthrough for women because:

• It accurately detects the presence of cell changes due to persistent HPV infection, enabling physicians to distinguish between benign infection and precancerous disease.
• An accurate diagnosis will reduce unnecessary testing
• Sample cells are collected from the cervix in the same manner as a pap test with virtually no discomfort.
• It can be administered during one office visit -- often at the same time as a pap test. 
• The test has a fast turn-around time, similar to an HPV DNA test.

About IncellDx, Inc.

IncellDx, Inc. is a molecular diagnostics company dedicated to the detection and monitoring of life threatening diseases such as cervical cancer, breast cancer, HIV/AIDs, hepatitis, and organ transplant rejection.