FREMONT, Calif., Nov. 18, 2013 /PRNewswire-iReach/ -- Every two minutes, a woman dies from cervical cancer. Yet cervical cancer can be cured when detected early. Four out of five of these deaths occur in developing countries because of the lack of screening programs. At the 2013 EUROGIN International Multidisciplinary Congress in Florence, Italy, investigators presented clinical studies' data on a novel technology from Arbor Vita Corporation (Fremont, CA, USA) that can change this situation.
OncoE6™ Cervical Test is simple, rapid, accurate, requires only minimal training, and delivers results in 2 ½ hours. In the START-UP clinical trial conducted by PATH and CICAMS (Chinese Academy of Medical Sciences), investigators reported on the remarkable accuracy of this technology to predict cancer. For women with advanced precancerous/cancerous lesions, investigators found that one out of two women testing positive by the OncoE6™ Cervical Test needed treatment (PPV of 41%), while only one out of ten women with positive HPV DNA or VIA (Visual Inspection with Acetic Acid) test results (PPV of 9%) required treatment. By detecting disease and not infections, fewer women will have procedures and scarce resources can be available for those women who are truly in need. The simplicity and performance of OncoE6™ Cervical Test makes it possible for a woman to be tested and treated all in the same day.
Jose A. Jeronimo, M.D., Director of the START-UP Project at PATH, commented, "The conclusive results from this study confirm that the Arbor Vita OncoE6™ Cervical Test has the clear potential to increase access to screening for women worldwide and to reduce global death rate due to cervical cancer. The test is unique in its performance characteristics and minimal resource requirements for testing, which support PATH's commitment to bringing affordable technologies to low-resource countries."
In a second clinical study conducted by the Charité Hospital in Berlin, Germany, investigators reported that a self-collected specimen is compatible with the use of the OncoE6™ Cervical Test. In developing countries, this opens up the possibility of testing in remote areas where there is a shortage of health care professionals and in areas where cultural barriers prohibit physician examination. In developed countries, routine sample collection could be performed by the patient without a doctor's visit.
A third study was conducted at the McMaster University / St. Joseph's Healthcare (Hamilton, Canada, ON) using the OncoE6™ technology to identify HPV-driven oral pharyngeal tumors. Since HPV is fairly common, testing for HPV alone was not informative for patient management. Investigators found elevated levels of E6 oncoprotein from fine needle aspirate specimens from head and neck tumors driven by HPV. By identifying the HPV E6 oncoprotein, physicians can now personalize their treatment for this class of patients that responds differently to therapy.
About OncoE6™ Cervical Test
Cervical cancer is caused by HPV (Human Papillomavirus). Most HPV infections do not progress to cancer and clear without treatment (greater than 99%). When HPV-infected cells become precancer or cancer, the virus infected cell makes the E6 protein in larger amounts. As the oncogenic driver, the E6 protein is the most informative biomarker to distinguish infection from cancer. The OncoE6™ patented technology will identify the 1% of women who truly need followup / treatment. Thus resources can be focused on the woman with disease and give peace of mind to the hundred plus other women who do not.
The idea for the OncoE6™ Cervical Test started nearly ten years ago with an initiative by the START program by PATH (funded through a grant from the Bill and Melinda Gates Foundation). Experts in cervical cancer from around the world were gathered and asked to come up with the ideal test for cervical cancer, the second most common cause of cancer deaths in women worldwide. The experts asked for a simple test that can be run anywhere in the world with minimal training and no refrigeration. It had to be accurate and with minimal "false" positives. Arbor Vita Corporation answered the challenge and developed the OncoE6™ Cervical Test which is now available in many parts of the world.
"The ease of use and the accuracy (99% specificity) allows us to bring timely results and to relieve anxiety about cancer to women around the world" said Peter Lu, M.D., Arbor Vita Corporation's CEO.
About PATH and START-UP
Initiated in 2008, the START-UP (Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention-Utility and Program Planning) project is focused on the development of simple, rapid, portable, and robust biochemical tests that are inexpensive, acceptable to women and healthcare providers, safe, accurate, and appropriate for use in low-resource settings. The START-UP clinical study organized by PATH and CICAMS, enrolled a total of 7,543 women, aged 25-65, in three rural sites in China. The study was designed to compare specificity and sensitivity across multiple screening regimens, including VIA, Arbor Vita Corporation's OncoE6™ Cervical Test and Qiagen's careHPV DNA Test (and provide a one year follow-up for all women with a positive test).
PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to improve break longstanding cycles of poor health, especially in low income and limited resource settings. By collaborating with public and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act in order to improve global health and well being.
About Arbor Vita Corporation
Arbor Vita Corporation is a privately held biotechnology company located in Fremont, California, USA founded in 1998 and focusing on the discovery, development and commercialization of a novel class of proteomic-based diagnostics and therapeutics. The company's proprietary PDZ protein technology platform continues to produce groundbreaking solutions to complex health challenges, including infectious disease, cancer, and neurological and cardiovascular disorders such as stroke.
For more information:
1 Zhao FH, Jeronimo J, Qiao YL, et al. An Evaluation of Novel, Lower Cost Molecular Screening Tests for Human Papilloma Virus. Cancer Prev Res 2013; 6:938-948.
Copyright © 2013 Arbor Vita Corporation
Media Contact: Peter Lu, M.D., Arbor Vita Corporation, 408-585-3900, email@example.com
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SOURCE Arbor Vita Corporation