A fast, fully automated bio-chemical system for detecting cervical cancer, developed by Ampersand Medical Corp. (OTC BB: AMPM), is capable of identifying the disease with greater accuracy than is routinely reported by Pap testing, concludes a presentation made today here at the 14th International Congress of Cytology.
Ampersand InPath™ System uses novel technology to produce fast, accurate results
AMSTERDAM, May 29, 2001 – A fast, fully automated bio-chemical system for detecting cervical cancer, developed by Ampersand Medical Corp. (OTC BB: AMPM), is capable of identifying the disease with greater accuracy than is routinely reported by Pap testing, concludes a presentation made today here at the 14th International Congress of Cytology.
In a paper to the Congress, Matthew D. Gombrich, M.S. senior scientist, presented findings of yet another study of Ampersand’s InPath™ Slide Based Test and InPath Cocktail-CVX™, which uses a biomolecular assay of protein targeted markers and stains tagged with fluorescence as a revolutionary approach to cancer screening. Results can be obtained from this system in less than 30 minutes.
The study, using a liquid-based slide preparation on 45 samples, demonstrated 100 percent accuracy for detection of high-grade squamous intraepithelial lesions, a condition characterized by the presence of pre-cancerous cells, and cancer. Additionally, the study demonstrated sensitivity for all grades of abnormality at 84 percent, and specificity -- the ability to correctly identify normal samples as normal -- was reported to be 81 percent compared with specificities below 60 percent routinely reported for Pap testing or the poor specificity levels reported for human papillomavirus DNA testing.
According to Gombrich, “Due to our use of multiple markers, the specificity is higher than other reported screening approaches. We suspect that in reality, it is even higher than reported and believe this to be true because what might appear as a false positive may in fact be the detection of bio-chemical changes before evidence of such changes are visible. We are actually detecting the problem before the Pap test can detect it, such as Smokey the Bear finds a fire before it starts to flame. Studies will commence to confirm this hypothesis.”
Unlike the basic protein research that is commonly conducted in histology and reported, the InPath System is unique in that it simultaneously screens for multiple protein-based markers within cytology samples, and does so in less than 30 minutes making it a very viable broad-scale platform for cancer screening of large populations. Future applications will involve screening for other types of cancers and conditions.
The InPath™ System is designed to be used in conjunction with, or as a replacement to, the conventional Pap test, liquid-based cytology specimens and the new InPath™ In-Cell HPV Test technology of the Ampersand InPath™ System.
Clinical trials for the InPath™ System are underway. Ampersand anticipates submitting the results of those trials later this year to the U.S. Food and Drug Administration for approval.
Commenting on the presentation, Peter Gombrich, Ampersand Medical’s chairman and chief executive officer and Gombrich’s father, noted, “The InPath System will allow physicians to identify patients requiring immediate intervention and management in the same way the Pap test does today, but early results suggest with greater accuracy. The InPath™ System also provides an unique optional means of detecting human papillomavirus in such a way that, based on our early results, suggest it may have the ability to predict those patients who may not need treatment today, but are likely to in the future. The entire InPath™ System is fast, cost-effective and can be easily implemented, even in remote parts of the world.”
The research for Matthew Gombrich’s presentation, titled “A Novel Multi-Parameter Assay for Cervical Cell Abnormality: Towards An Automated 21st Century Pap,” was conducted in laboratories at Ampersand Medical, Chicago; MacDonald Women’s Hospital, University Hospitals of Cleveland, and Case Western Reserve University, Department of Biochemistry, Cleveland.
About Ampersand Medical
Ampersand Medical Corporation develops cost-effective, laboratory-based and point-of-care screening systems to assist in the early detection of cervical and other cancers. The InPath™ System is being developed to provide medical practitioners with a highly accurate, low-cost, cervical cancer screening system that can be used at the point-of-care. Other products include AIM 2000, an automated system facilitating the analysis of medical samples and SAMBA™ Virtual Laboratory software used for medical image processing, database and multimedia case management, telepathology and teleradiology. More information is available on the Internet at www.ampersandmedical.com.
Certain statements throughout this release are forward-looking. These statements are based on the Company’s current expectations and involve many risks and uncertainties, such as the possibility that clinical trials will not substantiate the Company’s expectations with respect to the InPath System, and other factors set forth in reports and documents filed by Ampersand Medical Corporation with the Securities and Exchange Commission. Ampersand Medical Corporation undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
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