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Biotech / Medical : ACMI - Accumed Inc.

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To: Sigmund who wrote (720)	12/19/1997 12:48:00 PM
From: Frank Buck	Read Replies (2) of 1894

Sigmund, Have you seen the latest release from AutoCyte? Here is an excerpt. "AutoCyte believes that recent market developments have caused the FDA to focus more attention on the performance of monolayer devices in analyzing high grade and cancerous lesions. These developments include the citizen petition filed with the FDA by a number of parties, including two cervical cytology companies - Cytology West and Trylon - to review the claims allowed for Cytyc's ThinPrep(TM) membrane-based monolayer process." biz.yahoo.com Do you have any knowledge of what the citizen petition filing is seeking and in what capacity the two cervical cytology companies are being used for? It appears as though Cytology West and Trylon are independently reassessing the merits of the claims of the ThinPrep system. I wonder what the citizen petition filing is all about? The statement by AutoCyte...."recent market developments have caused the FDA to focus more attention on the performance of monolayer devices in analyzing high grade and cancerous lesions" seems consistent with the medical-detection enhancing companies desires (like NPTH) to engage their systems to be compatible with the newest monolayer slide process. This is exactly the point I was referring to when I stated that NeoPath would be looked at in a "brighter" light because of the latest clearance by the FDA for the CYTC ThinPrep System. It now appears that AutoCyte is attempting to discredit the merits of the ThinPrep Slides efficacy and gain acceptance for their own system. The only thing that is a sure thing at this point is that the overall sector will be quagmired by the litigation for a while. Hopefully the dust will settle soon. Frank

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