With more than 24 million U.S. women diagnosed annually with human papillomavirus (HPV), the cause of virtually all cervical cancer, Ampersand Medical Corp.’s new screening technique shows promise to identify those patients that truly need to be monitored.
Results Presented at International Congress of Cytology Conference in Amsterdam
AMSTERDAM, May 30, 2001 – With more than 24 million U.S. women diagnosed annually with human papillomavirus (HPV), the cause of virtually all cervical cancer, Ampersand Medical Corp.’s new screening technique shows promise to identify those patients that truly need to be monitored.
A study presented today at the14th International Congress of Cytology indicates that the InPath™ In-Cell HPV Test™ in early studies has demonstrated its ability to be the first screening test capable of detecting cases in which papillomavirus has disregulated the host cell’s central functions.
The study, conducted at five U.S. facilities, was presented by Bruce Patterson, M.D., lead investigator and senior research scientist at Northwestern University and a member of Ampersand’s Medical Advisory Board.
HPV is recognized as the causative agent for cervical cancer. Although many people are infected with HPV, relatively few of them develop neoplasia. In those who do develop neoplasia, the abnormal cells overproduce specific proteins encoded for by the virus’ E6 & E7 genes.
Although current HPV screening tests detect the presence or absence of HPV through DNA detection, they don’t detect the activity of HPV transforming genes. Detecting this activity may be integral in detecting and treating pre-cancerous conditions of the lower genital tract. Rather than detecting DNA, the InPath In-Cell HPV Test uniquely detects this activity through the detection of E6 & E7 messenger RNA. The test is both faster and more sensitive than HPV DNA testing.
In this study, of 82 samples, InPath In-Cell HPV Test accurately detected the presence of these proteins in 100 percent of patients with high-grade lesions and 64 percent of patients with low-grade lesions.
Regarding the results, Dr. Patterson said, “This technology is proving to be far more accurate than existing HPV-screening technologies and much faster and less costly than polymerase chain reaction, today’s ‘gold standard’ diagnostic tool for detecting HPV.”
The screening technique is designed to be compatible with the conventional Pap test, liquid-based cytology specimens and the new biomolecular-marker technology of the InPath System from Ampersand Medical. Clinical trials for the InPath System are underway. Ampersand anticipates submitting results of those trials to the U.S. Food and Drug Administration in the near future.
“We believe this early study will support the contention that a series of new fully automated tests based on chemistry rather than human judgment may soon replace the Pap test, while providing additional prognostic information on a patient’s well-being,” said Peter Gombrich, Ampersand Medical’s chairman and chief executive officer. “The Pap test was revolutionary when it was introduced some 50 years ago, but early studies of the InPath System are continuing to demonstrate that it is significantly faster, more accurate, and more cost effective. We look forward to continuing to validate its performance in the larger-scale clinical trials.”
Ampersand’s InPath System, based on the use of biomolecular markers tagged with fluorescence, is considered a revolutionary approach to cervical-cancer screening. The broad-based system includes the use of multiple protein-based probes and stains used in combinations that are able to detect low- and high-grade dysplasia and cancer.
The research for Dr. Patterson’s presentation, titled “In-cell Quantification of HPV mRNA Expression as a Cervical Cancer Screening Tool” was conducted in laboratories at Children’s Memorial Hospital, Chicago; Ampersand Medical Corp., Chicago; and Invirion Inc., Frankfort, Mich. Patterson is a medical advisor to Ampersand.
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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