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

To: Cole who wrote (1628)	4/12/1998 11:02:00 AM
From: Frank Buck	Read Replies (1) \| Respond to of 1894

Cole, AccuMed provides laboratory enhancing (semi-automated screening) equipment to laboratories engaged in the screening of female PAP smears. The AcCell/TracCell system enables cytotechnologists to thoroughly scan all pertinent areas of a cervical tissue sampling and make a non-computer evaluation of the cellular material. The assignment of a certain level of normalcy or abnormality by cytotechs is regulated according to a standard classification system known as the Bethesda System. Digene's (DIGE) lead product provides a proprietary process to laboratories for the early detection of cervical HPV virus. Some studies indicate a 95% correlation between HPV and cervical cancer. Current PAP smear screening methods are supposedly only able to detect 70% - 75% of HPV virus. The DIGE article mentions they are commencing clinical trial studies in the U.K. The U.K. is an area with an unusually poor performance record of cervical abnormality detection (for an industrialized nation). Digene will be employing a Hybrid Capture DNA/RNA Assay. Digene's process allegedly determines the presence of HPV virus by a complex DNA determination and is an automated process. No categorical determination of the outcome is required as with the Bethesda System. The latent determination of a viral (HPV) presence is supposedly a more effective early warning sign. Digene is looking to compile clinical study data in the U.K. so as to submit the Hybrid Capture DNA Assay for FDA approval as a primary screening mode. Currently the FDA has only approved the Hybrid Capture DNA process in the U.S. as an adjunct to the conventional (50 year tried and true) PAP smear screen. New systems and technologies are constantly being developed for this potential $2 Billion international market sector. The new health-care paradigm mandates any new technology afford a better qualitative and more attractive economic price structure. This board has and will continue to monitor any and all cervical screening sector participants that make that claim. Frank