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Biotech / Medical : ACMI - Accumed Inc.
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To: Sigmund who wrote (706)12/18/1997 1:18:00 AM
From: Frank Buck  Read Replies (2) of 1894
 
Sigmund,

First of all I should state the the information I have regarding the inability of the NeoPath System to read the ThinPrep Mono-layer slide comes from the Motley Fool Article of 11/03/97. Here is the quote;
"If the Cytyc thin-prep becomes the standard test for cervical cancer
screening, Neuromedical Systems and Neopath may be in trouble.
Autocyte's machine can screen the thin-prep specimens;
Neuromedical's cannot."
fool.com
(By the way did you know that AccuMed's system is capable of working with the CYTC ThinPrep Monolayer slides?)

Secondly while I agree that they are two mutually exclusive entities,
it is my belief that the FDA approval of the CYTC Thin Prep System has turned up the heat for all perspective FDA approval seekers in this sector. The NeoPath system for automated detection of aberrant H.P cells was originally deemed unsafe by the FDA. This second attempt may be suspect due to the considerable amount of data given to the FDA with the consideration for approval of the ThinPrep System. In other words a higher degree of sophistication is implied by the FDA reviewal of the ThinPrep System. The NeoPath machines inability to read the newest slides shouldn't in and by itself preclude the FDA from granting or denying approval to NeoPath.

However the above sited "new awareness" coupled with the numerous allegations being thrown about in this sectors court battles may raise eyebrows in an FDA Approval Panel. The fact that the lawsuits are still hanging may compound the safety issue enough to preclude the FDA from giving approval under the auspice that additional data is needed to confirm the safety allegation. The FDA Approval Panel realizes that whatever they do at this point will be closely scrutinized in court. Disected step by step if need be. I am assuming if they are going to make a move, it will be to "error" on the side of waiting for more studies. The safety aspects of an automatic computer assisted microscope system for the detection or absence of a few aberrant cell seems sufficient to warrant the highest level of all available data. Not just data submitted by the company that has a vested interest in the marketing of the product. The trials will bring to light all data from all the players. What has the FDA got to loose by gaining approval right now? What do they have to loose if they don't grant approval?

Sorry but I don't think NeoPath is gonna make it in January. Judging from the shorts I am not alone in my perception.

Hope this answers your question.

Frank
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