MonoGen, Inc.
TSX : MOG

MonoGen, Inc.

October 22, 2007 08:46 ET

MonoGen Submits 180-Day PMA Supplement for New Manufacturing Facility

CHICAGO, ILLINOIS--(Marketwire - Oct. 22, 2007) - MonoGen, Inc. ("Corporation") (TSX:MOG) today announced that it has submitted a 180-Day PMA Supplement seeking FDA approval to manufacture the MonoPrep Pap Test at its new manufacturing facility located in Waukegan, Illinois. MonoGen expects that the FDA will complete review and action on this supplement within 180 days.

Ted S. Geiselman, MonoGen's President and CEO, commented that "We are extremely pleased to have completed this effort and are looking forward to the FDA's review of the submission. In addition, we anticipate a facility inspection as part of this process sometime in the next several months. Although approval by the FDA of this facility is the final objective, this submission is a significant first step in the process."

With operational headquarters in the United States (Greater Chicago area), MonoGen is a medical device company developing an integrated suite of fully automated devices (the SAVANT LABORATORY SYSTEM™) for anatomic pathology laboratories. The SAVANT LABORATORY SYSTEM™ is being designed to automate processes performed by clinical laboratories to reduce their costs, increase throughput, and improve the quality and consistency of results.

The common shares of the Corporation are listed for trading on the Toronto Stock Exchange under the trading symbol "MOG".

Forward-Looking Statements

This press release contains statements that are forward-looking in nature. 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 MonoGen's ability to raise additional capital, MonoGen's ability to execute its business plan while obtaining and maintaining at all times its various regulatory approvals, the performance of its strategic partners in the commercialization of the Corporation's 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 the Corporation undertakes 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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