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Biotech / Medical : Acyt soon to receive FDA approval

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To: telephonics who wrote (3)2/13/1999 8:50:00 AM
From: Grainne1 Recommendation  Read Replies (1) of 8
 
Telephonics, I cannot answer your question about whether the cells being analyzed are the correct particles. I do know that Autocyte is already doing this accurately somehow, as is evidenced by this report which came out last week, that I pulled from the Yahoo Autocyte thread. What company are you referring to with the DNA analysis sysem, incidentally:

messages.yahoo.com@m2.yahoo.com

Positive clinical studies for SCREEN and
PREP
by: MedRanga2
436 of 474
Tuesday February 9, 2:22 pm Eastern Time
Company Press Release
SOURCE: AutoCyte, Inc.

Recently Published Studies Demonstrate Promise of AutoCyte Prep and AutoCyte Screen for
Cervical Cancer Screening

BURLINGTON, N.C., Feb. 9 /PRNewswire/ -- AutoCyte, Inc. (Nasdaq: ACYT - news)
today announced that four separate scientific publications report on different studies which
address performance of AutoCyte PREP and AutoCyte SCREEN when compared to
conventional Pap smear methods. The reports are published in the January-February 1999
peer-reviewed issue of Acta Cytologica, a prominent medical journal focusing on diagnostic
cytology.

One publication was authored by Pierre Vassilakos, M.D. (Laboratory Cyto- Path,
Carouge-Geneve, Switzerland) Jacques Saurel, M.D. (Institut d'Histo- Cyto-Pathologie, Le
Bouscat, France) and Raymond Rondez, M.D. (University of Zurich), and included the
individual and combined results of their studies of the AutoCyte liquid-based preparation
(''LBP'') system. The studies compared AutoCyte's liquid-based preparation in its intended,
direct-to-vial use with the conventional Pap smear in large patient populations. The total
population for the three studies was 200,000 women. Combined, these studies reported the
following favorable results for the AutoCyte liquid-based preparation method when compared
to the conventional Pap smear:

* Increased the detection of low-grade squamous intraepithelial lesions
("LSIL") by 59%
* Increased the detection of high-grade squamous intraepithelial lesions
and cancer ("HSIL+") by 79%
* Decreased the uncertain ASCUS/AGUS classification by 43%
* Decreased the satisfactory-but-limited-by ("SBLB") classification by 74%
* Decreased the unsatisfactory classification by 90%.

The study concluded that ''results cited in these studies are consistent with findings of other
LBP direct-to-vial studies, which have also demonstrated significant cytologically determined
improvements in sensitivity and specificity. Direct-to-vial studies of LBP performance (intended
use) have consistently demonstrated significantly better results than in studies limiting the LBP to
residual material after conventional Pap smear preparations (''split-sample'').'' The results of the
Vassilakos and Saurel studies were also presented at the 21st International Tutorial on Clinical
Cytology in Vienna, Austria on December 6th.

Results from a masked multi-site trial by Dr. John Bishop, Dr. Raymond Kaufman and Dr.
Dugald Taylor were presented showing that routine use of the AutoCyte SCREEN together
with the PREP could offer an effective alternative to the conventional Pap smear, screened
manually. In this study, LSIL+ and HSIL+ cases undergoing manual screening alone had a
sensitivity of 89% and 90% respectively, compared to 98% and 99% for the AutoCyte
SCREEN-assisted practice.

Dr. Lydia Howell et. al. published the results of an evaluation of the AutoCyte SCREEN as a
prescreener for the cytologic detection of cervicovaginal abnormalities. In this study, 856 cases
prepared on the PREP system were evaluated by the AutoCyte SCREEN and a
cytotechnologist to produce an interactive diagnosis of each case. The false negative proportion
was 10.5% for the interactive diagnosis and 15.7% for manual review for LSIL, concluding that
the interactive use of the AutoCyte SCREEN could effectively select those cases most likely to
contain an epithelial abnormality and could increase laboratory efficiency.

In another study by Dr. Bishop et. al. it was concluded that residual AutoCyte cervical cytology
samples are stable and yield reproducible results for routine and ancillary studies for cervical
cytologic abnormalities.

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