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Biotech / Medical : ACMI - Accumed Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Sigmund who wrote (714)	12/18/1997 11:39:00 AM
From: Frank Buck	Read Replies (1) \| Respond to of 1894

Sigmund, After reading the Motley Fool statement again several times, I too agreed that it was evasive on whether or not the NeoPath system could indeed read the CYTC ThinPrep Monolayer System. It alludes and makes inference but does NOT specifically state such. I have contacted Stacie Byars, Investor Relations for NeoPath and addressed the question to her. Wonderful speaker and extremely informed on most aspects of her Companies existing situation. Her response indicates that while NeoPath is not currently FDA regulated to read the ThinPrep monolayer slides it has been engaged in pilot-studies to do so. She stated that the AutoPap system is fully capable of reading the monolayers slides and would be seeking the FDA approval process at some time in the future. Obviously she stated their main thrust right now is obtaining FDA approval for the AutoPap as a primary reader. We further discussed the AccuMed AcCell/TracCel system should NeoPath receive FDA approval for primary screening. Her feeling along with that of AccuMed's is should the FDA grant the AutoPap approval, the laboratory markets will see a needed increase for compatible augmenting systems such as the AcCell/TracCell. In expectation of the higher expected need for augmenting systems that would help in the evaluation of the 75% of slides kicked back for manual consideration, NeoPath is also working on a "less sophisticated and substantially less expensive" system similar to AccuMed's AcCell/TracCell for their AutoPap. It is called the PathFinder. Again she said their first order of priority is obtaining FDA approval in January '98 for the AutoPap. She did agree with my supposition regarding the FDA having a higher standard due to the recent approval in the sector. Even though the FDA approval process they are seeking is for hardware she stated that "the bar has been raised" as of late. She also stated that the FDA approval process is a scientific evaluation concerning safety and not dealing in the politics of the ongoing lawsuits, the FDA is aware of all the data and machinations ocurring presently in the industry. She was extremely optimistic that in the year time between FDA periods that NeoPath has been extremely busy providing the data that the FDA was looking for. She felt that they were amply equipped for January. Frank