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


To: Cisco who wrote (572)11/25/1997 12:13:00 AM
From: John Zwiener  Respond to of 1894
 
Hi CISCO, it's hard to know how to answer the learned populist cytologist. I generally form impressions from detailed reading and I do not tend to believe what I read. In cytc's case, their are other studies that where also considered in FDA approval as I remember it.

There continue to be more, and these are even more impressive. Also keep in mind that in these studies, the Pap was done first (decreasing the number of cells available). So the thinprep had an inherit disadvantage, but still does better. Here are the latest studies (the australian study is very impressive...you can find more details on yahoo)...

In a study conducted at the University of Kentucky, Dr. Jacqueline Emery compared the ThinPrep Pap Test to the conventional Pap smear in a high-risk population. Dr. Emery found that the ThinPrep method identified almost twice as many (72 percent more) pre-cancerous or cancerous lesions than the conventional smears. The ThinPrep method also reduced the number of equivocal or ''ASCUS'' diagnoses by over 30 percent. In addition, the ThinPrep method also significantly reduced the number of samples compromised by obscuring factors. The study titled, ''The ThinPrep Method for Cervical-Vaginal Specimens in a High-Risk Population'' concluded, ''These preliminary findings indicate several advantages for the ThinPrep method in a high-risk population: identification of more pre-malignant lesions, reduction in the number of inconclusive diagnoses and improved specimen adequacy.''

In another study of over 50,000 patients in Australia, Dr. Colin Laverty found that more cervical abnormalities were identified on ThinPrep slides than on conventional Pap smears. The ThinPrep Pap Test also resulted in an increase in biopsy confirmed high-grade lesions and improved specimen adequacy.

Dr. James Linder presented a detailed examination of sampling and screening errors, which led to false negative diagnoses. The study, ''ThinPrep Pap Testing to Reduce False Negative Cervical Cytology,'' found that sampling error, resulting from the manual preparation of the Pap smear, was responsible for 71 percent of conventional false negatives. The ThinPrep Pap Test yielded a 3.6-fold reduction in the sampling false negative rate and reduced the false negative fraction (screening error) by 60 percent.

In a study conducted at the University of Texas-Houston Medical School, Dr. Mary Yang focused exclusively on specimen quality. ''Comparison of Specimen Adequacy between Matched ThinPrep Preparations and Conventional Cervicovaginal Smears'' concludes that ThinPrep demonstrated a marked improvement in specimen adequacy. The study design used one cervical sample from which a conventional Pap smear was made first and then only the residual material was rinsed into a vial. The author notes that further improvement would be expected if ThinPrep specimens are collected directly to the vial as they are intended in routine use.

Two studies reported on the viability of additional clinical testing with the fluid-based ThinPrep System. Dr. George Birdsong, from Grady Memorial Hospital in Atlanta, Georgia, found that samples collected in PreservCyt transport, the preservative medium used with the ThinPrep Pap Test, can be utilized for testing for human papillomavirus (HPV) using the Digene (Nasdaq:DIGE) Hybrid Capture(R) Assay. The U.S. Food and Drug Administration (FDA) approved such use in September 1997.

I still have not found a study that did not confirm my original impressions of cytyc Also, the FDA says that cytyc can claim a 65% increase in detection of LSIL. I don't know the point of the populist cytologist article, I won't guess