MonoGen, Inc.
TSX : MOG

MonoGen, Inc.

January 29, 2008 15:47 ET

MonoGen Announces Publication of Pivotal Clinical Trial

CHICAGO, ILLINOIS--(Marketwire - Jan. 29, 2008) - MonoGen, Inc., ("Corporation") (TSX:MOG) today announced that the findings of its pivotal clinical trial of MonoPrep® have been published in the February 2008 issue of the peer-reviewed American Journal of Clinical Pathology.

Primary author, Edmund S. Cibas, MD, Director of Cytopathology at Brigham and Women's Hospital and Associate Professor of Pathology at Harvard Medical School reported that slides prepared by the MonoPrep Pap Test method, compared to the Pap smear, yielded statistically significant increases in true positive cytologic results, as judged by an Independent Pathologist (IP), for the diagnostic thresholds of ASC-US+ and LSIL+, without a significant, corresponding increase in false positives.

This prospective, split-sample trial of 10,739 women was conducted at 88 clinical sites (73 USA, 11 South Africa, 2 Venezuela), representing the largest FDA clinical study to date of a liquid-based Pap test. In this split-sample collection study, a conventional Pap smear was obtained first and prepared according to standard methods, then the residuum on the collection devices was rinsed in MonoPrep Pap Test collection vial. The primary objective was to assess the effectiveness of MonoPrep against the Pap smear in cases of atypical squamous cells of undetermined significance and more severe lesions (ASC-US+), and low-grade squamous intraepithelial cells and more severe lesions (LSIL+).

For cases with IP confirmation of ASC-US+ and LSIL+, MonoPrep detected, respectively, a statistically significant 1.15 and 1.26 times more true positive cases than Pap smear for all sites combined. Further, of the 10,739 cases, there were 302 unsatisfactory slides (UNSAT) by conventional Pap smear compared to only 126 reported by MonoPrep. That represents a 58% reduction in UNSATs, and the largest reduction in UNSAT rate for any of the three FDA approved liquid-based Pap tests against Pap smear.

Based on the strength of the findings, the report concludes that, "These results are arguably stronger than those obtained in multi-center split sample clinical trials of 7,360 ThinPrep® Pap tests and 8,983 SurePath® Pap tests." Although the data between the 3 tests are not directly comparable, the authors note that, "The difference between smear and SurePath in the detection of epithelial lesions was not significant for ASC-US+ or LSIL+, and in the ThinPrep clinical trial, the increase in detection was significant for ASC-US+ and LSIL+ for some trial sites." MonoPrep increases at these two thresholds were observed for all study laboratories.

The authors also noted the improvements in slide preparation efficiencies such as fully automated processing, end-to-end bar coding technology that ensures accurate specimen identification, prevention of cross-contamination by automated vial and waste handling, aerosol prevention, discrete slide fixation and dry slide storage, and automated vial resealing using plastic film." Their conclusion: "The MonoPrep Pap Test system is an effective method for preparing gynecologic cytology slides to screen for cervical abnormalities and can serve as a replacement for the Pap smear."

Juan Felix, MD, MonoGen's new Medical Director states, "This compelling data was a deciding factor in my joining MonoGen. With MonoPrep, labs and clinicians have a valuable new tool with which to help their patients. We continue to study other gynecologic and non-gynecologic applications with MonoPrep, and are pursuing publications and new marketing claims to further highlight its clinical and practical benefit."

About MonoGen

With operational headquarters in the United States (Greater Chicago area), MonoGen is a medical diagnostics company developing fully automated devices for anatomic and molecular pathology laboratories. MonoGen's initial product, the MonoPrep Processor, has been designed to automate processes performed by these laboratories to reduce their costs, increase throughput, and improve the quality and consistency of results.

Forward-Looking Statements

To the extent any statements made in this press release contain information that is not historical; these statements are essentially forward-looking in nature and are subject to risks and uncertainties. Statements preceded by the words believe, expect, anticipate, plan, intend, continue, estimate, may, will, and similar expressions are forward-looking statements.

Forward-looking statements are based on the Corporation's beliefs and assumptions based on information available at the time the assumption was made. Forward-looking statements relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, new services, market forces, commitments and technological developments, relating to the Corporation. By its nature, such forward-looking information is subject to various risks and uncertainties which could cause the Corporation's actual results and experience to differ materially from the anticipated results or other expectations expressed. Those risks and uncertainties include, but are not limited to, our ability to raise additional capital, our ability to execute our business plan while maintaining at all times our various regulatory approvals, the performance of our strategic partners in the commercialization of our products in the marketplace and the competitive response from existing and potential competitors. Readers are cautioned not to place undue reliance on this forward-looking information, which is given as of the date it is expressed in this document, and we undertake no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise.

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