CHICAGO, Oct. 1, 2001 (PRIMEZONE) -- Molecular Diagnostics, Inc., formerly Ampersand Medical (OTCBB:MCDG), announced today that it has submitted a 510(k) application to the United States Food and Drug Administration for clearance to market the company's InPath e2 Collector, a novel cervical sampling device to be used in Pap testing. The submission is based on data amalgamated from several studies undertaken at Cleveland Clinic Foundation, University Hospitals / Case Western Reserve (Cleveland, OH), and Northwestern University Medical Center (Chicago, IL).
The InPath e2 Collector is a unique approach to obtaining a sample of cervical cells for Pap test analysis and/or for sexually transmitted disease testing, including human papillomavirus (HPV). The e2 Collector is based on a unique silicone balloon shaped like a mirror image of the cervix. When inflated in the cervix, cells adhere to the balloon's surface.
"Data from the study supports our claim that the e2 Collector is substantially equivalent to the conventional spatula and brush combinations primarily used in obtaining a sample today," said Robert L. Habig, Ph.D., senior vice president of clinical and regulatory affairs for Molecular Diagnostics. He added, "The data from this study is sufficiently compelling that we were able to submit this application with fewer patient samples than originally expected." "Data were pooled across centers and the observed rate of satisfactory for the Standard method was 96.2%, and the observed rate of satisfactory for the e2 Collector was 100.0%," according to Dr. Kinley Larntz, statistical consultant.
Molecular Diagnostics' InPath System comprises several components, including the e2 Collector, and two bio-molecular assays to detect cervical cancer and patients infected with the human papillomavirus (HPV). The assays can be applied to a microscope slide in a laboratory, or directly on the e2 Collector, potentially allowing for a point-of-care result. Initial data on the company's bio-molecular assays has proven to be 100% sensitive for detection of cervical cancer and High-Grade disease. The InPath System simultaneously screens for multiple bio-molecular markers within cytology samples in less than 20 minutes. Future applications will involve screening for other types of cancers and conditions.
According to Eric Gombrich, vice president of business development for Molecular Diagnostics, "The majority of the women in the study indicated a preference for the e2 Collector based on comfort. Because of this, we expect to be able to offer this as an alternative to the current collection devices. Although, the primary objective in developing the e2 Collector was for use in point-of-care testing with the complete InPath System."
About Molecular Diagnostics
Molecular Diagnostics, (formerly Ampersand Medical Corporation) develops cost-effective cancer screening systems which can be utilized at the point of care or in a laboratory, to assist in the early detection of cervical, gastrointestinal and other cancers. The InPath(tm) System is being developed to provide medical practitioners with a highly accurate, low-cost, point-of-care cervical cancer screening system. Other products include SAMBA(tm) Telemedicine software used for medical image processing, database and multimedia case management, telepathology and teleradiology.
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(tm) System, and other factors set forth in reports and documents filed by Molecular Diagnostics, Inc. with the Securities and Exchange Commission. Molecular Diagnostics, Inc. undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
This release can be viewed at Press Release Network site at http://www.pressreleasenetwork.com.