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MCDG - Very nice news - CytoCore's InPath System Upgrades Pap Test with FDA Approved e2 Collector; New Drug Delivery System Offers Treatment Options for Cervical Lesions Mar 22, 2006 10:00:00 AM Copyright Business Wire 2006 CHICAGO--(BUSINESS WIRE)--March 22, 2006--
CytoCore, Inc. (OTCBB: MCDG), with its recent product licenses, has assembled in four product components called the InPath System NG, a unique and complete system to address the various aspects of the traditional Pap test : the e2 Collector, the CVX/GCI Assay, the AIPS automated microscopy platform, and a new Drug Delivery System. Each product is an enhancement or upgrade to the current methods being used with the Pap test today.
The e2 Collector which is FDA approved and will be available for sale late summer this year, starts the Pap test with a proven more accurate cell collection than the current spatula and brush method. The results of the FDA trial demonstrated that for women with an abnormal Pap test, the e2 Collector because of its patented design and functionality is able to collect a better sampling of cells from the opening and into the cervical canal. In the FDA trial, the Collector produced zero false positives and half the false negatives of the spatula and brush. The company believes that this product will be of special interest to women who have recently tested positive for the newly introduced HPV test. Patients with this virus would more likely have the abnormal PAP tests. The e2 Collector will provide the best collection of cells available making sure the patient's test is the most accurate possible.
The Pap test slide will be analyzed with the new CVX/GCI Assay which uses a unique patent pending combination of bio-markers to accurately identify cells that are turning cancerous or about to turn cancerous. Using a technology called proteomics, the Assay turns these target cells a fluorescent color so they can be identified more accurately and easily. Initial lab tests indicate this Assay has accuracy rates from 87% to 100% accurate. These numbers compare very favorably with current Pap test rates which range from 50-70% accurate. And, the bio-marker Assay will deliver these results 7/24 without fatigue or a drop off in performance. Patient trials will commence later this year.
The next component, the Automated Image Proteomic System (AIPS), an automated image guided microscopy screening system, automatically scans the slide(s) for the presence of fluorescence and marked cells, and defines their location in the software database. Then later, it will guide the operator to the marked cell's location, allowing the trained Cytologist to spend their time examining these marked cells for the presence of cancer, not spending their time looking through hundreds of thousands of cells for those few that might be dangerous. CytoCore believes the combination of the CVX/GCI Assay and the AIPS platform will bring a new unmatched level of accuracy to the Pap test. The product combination of the Assay and AIPS system has been designed so that it can produce an accurate cervical cancer screening test anywhere in the world. This combination should be especially helpful to those women and their countries that do not now have access to Pap tests because of a lack of available cytologists and laboratories. The AIPS system will be available for manufacturing and testing this summer.
The last component of the InPath System is the new patent pending Drug Delivery System, providing for the first time a therapeutic treatment option for early stage cervical lesions. This system is based on a modification of the e2 Collector combined with existing FDA approved Patch technology. The Patch technology will provide the ability to deliver drug compounds in a controlled release manner, directly, specifically, and safely to the cervical surface. With partners, the Company expects to develop several compounds for the Patch: a mild to moderate chemo compound, an anti-viral compound for treating the HPV virus, and an immune-enhancement compound. These various Patch compounds should give to the physician for the first time real choices in how to address moderate to high grade cervical lesions. The Company expects to commence patient trials later this year.
CytoCore's CEO, Dr. David Weissberg stated: "With the recent announcements of the two new products we've licensed from University Hospital's of Cleveland in association with Dr. George Gorodeski, CytoCore now has a complete System to address the issues and requirements of Cervical Cancer screening and treatment. Each of the four components of the InPath System will deliver a significant improvement to the current methods now used with the Pap test to collect and analyze cells. The e2 Collector improves the cell collection and therefore the accuracy of the Pap test; the CVX/CGI Assay should significantly increase the accuracy of identifying potentially dangerous cells; the AIPS platform will scan and locate the marked cells for cytologist thereby improving the screening accuracy; and then the Drug Delivery System will give the physician a for the first time a choice on how to respond to the abnormal Pap test. While each of these products can be used separately, there is nothing even remotely like this product combination on the market today. We expect the InPath System to become a significant force in reducing the risk of cervical cancer among women world wide."
Dr George Gorodeski, head of CytoCore's Medical Advisory Board and its director of basic research stated, "With these products, CytoCore has assembled a fully integrated System that uses state of the art technology to significantly upgrade each aspect of the Pap test offering a very large increase in its capability, accuracy and reliability. In my opinion as a life long Gynecological Physician and Researcher, the InPath System is truly unique, and it will make a major impact with the Pap test and the whole area of Cervical Cancer detection and treatment, thereby saving many lives both here and around the world."
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CytoCore's InPath System Upgrades Pap Test with FDA Approved e2 Collector Business Wire (Wed 10:00am) MOLECULAR DIAGNOSTICS INC Financials EDGAR Online Financials (Thu, Mar 16) MOLECULAR DIAGNOSTICS INC Files SEC form 10KSB/A, Annual Report EDGAR Online (Mon, Mar 13) Crain's Cleveland article features CytoCore's new products licensed from University Hospitals Cleveland Business Wire (Tue, Mar 7) CytoCore CEO and Scientific Advisor to Discuss New Technology in CEOCast Interview Today, March 3rd Business Wire (Fri, Mar 3) CytoCore Announces Licensing the First Drug Delivery System That Therapeutically Addresses Cervical Cancer Lesions Market Wire (Wed, Mar 1) CytoCore CEO and Scientific Advisor to Discuss New Technology in CEOCast Interview This Friday, March 3rd Business Wire (Mon, Feb 27) CytoCore Announces Purchasing a Contract for an Undiluted Interest in Diamics, Inc. Business Wire (Fri, Feb 24) CytoCore Announces Licensing the First Drug Delivery System That Therapeutically Addresses Cervical Cancer Lesions Business Wire (Thu, Feb 23) CytoCore Announces the Licensing of a New Bio-Marker That Identifies Uterine Pre-Cancerous and Cancer Cells Business Wire (Tue, Feb 21)
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