Pivotal Study Of SoftPAP Collector Demonstrates Significant Improvements Over Conventional Collection Technique For PAP Sample

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Sexual Health / STDs;  Women's Health / Gynecology;  Medical Devices / Diagnostics
Article Date: 29 Oct 2008 - 9:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

CytoCore Inc. (OTCBB:CYOE), the developer of cost-effective, screening systems for early detection of gynecological cancers and sexually transmitted diseases, today announced the data analysis from its 703 patient clinical trial on Adequacy, Efficacy and Safety between the SoftPAP® Collector compared to the standard Spatula/CytoBrush Technique. Results showed statistically significant improvements versus the Spatula/Cytobrush, which is commonly used by many physicians as the collection device for obtaining the PAP sample. Test results, involving seven sites in the continental United States, showed SoftPAP demonstrated better "sensitivity" (the ability to detect abnormal results such as cancerous and precancerous lesions) and better "specificity" (the accuracy of the determination) than the Spatula/Cytobrush.

SoftPAP's superiority in "sensitivity" is reflected in SoftPAP's 26% percent improvement or reduction in false negatives, an indication where precancerous or cancerous conditions are detected in samples collected using SoftPAP but not detected in samples collected using the Spatula/Cytobrush. SoftPAP's superiority in "specificity" is reflected in SoftPAP's 33% improvement or reduction in false positives, an indication where the patient has been inaccurately diagnosed as having a precancerous or cancerous condition.

Robert McCullough, Jr., Chief Executive Officer of CytoCore commented, "Along with providing a better sample as demonstrated by this trial's superior results, the SoftPAP cervical cell collector should provide women a more comfortable experience during the PAP examination. When compared to the abrasive nature of the Spatula/Cytobrush, which many times can result in such side effects as bleeding and cramping, the SoftPAP collector is easier to use, faster and more accurate. One of the sites used in the clinical trial has agreed to sponsor the publication of the SoftPAP clinical trial results. Also, the dissemination of this data should be helpful to our distributors as they introduce SoftPAP to their customers."

"The need for a reliable more effective cervical cell collector is obvious," said Dr. Seth J. Herbst, MD, F.A.C.O.G., President of the Institute of Women's Health and Body. "The SoftPAP cervical cell collector offers a dramatic improvement over today's conventional collection method for the PAP test. The SoftPAP collector offers fast, more accurate specimen collection with less possibility for user error, which reduces the number of PAP tests that are misdiagnosed due to obscurity and thereby yielding fewer false positives and false negatives. I believe SoftPAP will become the standard of care for all PAP smears," Dr. Herbst concluded.

Conventional specimen collection is a two-step process: first using a spatula to harvest cells from the outer cervix (ectocervix), second using a brush to harvest cells from the less accessible cervical canal (endocervix). Failure to harvest a sufficient number of cells results in the specimen being "unsatisfactory" for diagnosis. Furthermore, because cervical cancer and its precursor states have a tendency to begin in the transition zone which lies between the ectocervix and endocervix, collecting cells from the transition zone is critical to the early detection of this highly preventable and treatable disease.

The SoftPAP cervical cell collector offers a quicker, more accurate specimen collection with minimal possibility of user error. It is designed to consistently sample the entire cervix in a single-step using an inflatable balloon collector. The patented single-use silicon balloon is a mirror image of the surface of the ecto- and endo-cervix. During collection, the balloon is slightly inflated by pressing a button on the collector handle. The volume of air is fixed and controlled so over- or under-inflation cannot occur. When the balloon inflates, its surface comes into contact with all walls of the entire cervix in a single step. Cells are collected from 360 degrees around the ecto-cervix, the transition zone and from within the endo-cervix. No rotation is necessary. As evidenced by the results of the clinical trial, sampling in this manner improves the sensitivity and specificity of the diagnosis, provides ease of use for the physician, and offers greater patient comfort.

About CytoCore Inc.

CytoCore develops cost-effective, highly accurate screening systems for early detection of gynecological cancers and sexually transmitted diseases. Designed for easy deployment at a laboratory or at the point-of-care, the CytoCore suite of sample collection technologies assists in the detection of cervical, endometrial, and other cancers, as well as the human Papilloma virus. The CytoCore Solutions™ System is being developed to provide medical practitioners with highly accurate, low-cost, cervical and uterine cancer screening systems that can be seamlessly integrated into existing medical models. More information is available at: http://www.CytoCoreInc.com.

Certain statements in this release are forward-looking. These statements are based on CytoCore's current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore's expectations with respect to the CytoCore Solutions™ System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore's current expectation depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-KSB for the year ended December 31, 2007. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein.

CytoCore Inc.