Bio Screening Industry News

In-house and External Retrospective Research Studies Incorporating ProEx C
Biomarkers Presented at 53rd Annual Scientific Meeting of the American Society
of Cytopathology

BURLINGTON, N.C., Nov. 7 /PRNewswire-FirstCall/ — TriPath Imaging, Inc.
(Nasdaq: TPTH) today announced that the results of a new in-house
retrospective research study demonstrated that testing of cervical cytology
specimens with Research Use Only (RUO) reagents incorporating the Company’s
proprietary ProEx C biomarkers yielded a 93% (p<0.0001) improvement in
sensitivity for detection of biopsy evidence of high grade cervical
intraepithelial neoplasia (CIN2+) when compared to a high grade abnormal
cytology classification of HSIL+. The results of this retrospective research
study also demonstrated a 65% improvement in calculated Positive Predictive
Value for detection of CIN2+ when compared to all atypical and abnormal
cytology classifications combined, defined as ASCUS and higher (ASCUS+).
These and other data relating to the performance of the ProEx C biomarkers
as well as an array of clinical and research studies incorporating the
SurePath liquid based Pap test were presented at the 53rd Annual Scientific
Meeting of the American Society of Cytopathology (ASC) in San Diego,
California. In conjunction with the meeting, the Company is also sponsoring
two symposia entitled “A New Era in Cervical Cytology: Revealing Clues from
the Cell-Cycle” and “Molecular Technology for the Cytology Lab: Initial
Impressions of In-House Use of ProEx C”.

Data from In-House Research Is Consistent with Previously Reported
External Research Studies
In a platform presentation made to the plenary session of the ASC meeting,
Adriann Taylor, Director of Product Development at TriPath Oncology, discussed
the results of a new in-house research study that was designed to evaluate the
performance of RUO reagents incorporating ProEx C biomarkers in a
retrospective study of 1,600 cervical cytology specimens collected using the
SurePath test pack. This retrospective cohort included 939 specimens that had
been classified as atypical or abnormal (ASCUS+) by standard microscopic
examination. For the purpose of this retrospective research study, the ProEx
C biomarkers were incorporated into RUO reagents designed to cytochemically
distinguish the presence of the over-expression of proteins associated with
aberrant S-phase induction in cervical smears that have been classified as
atypical or abnormal according to the generally accepted Bethesda 2001 System
for classification of cytologic morphology.
In this pre-clinical research study, the sensitivity of testing with RUO
reagents incorporating the ProEx C biomarkers for detection of biopsy evidence
of CIN2+ was 96.2%, a 93% improvement (p<0.0001) when compared to
classification of HSIL+ by microscopic examination. The calculated Positive
Predictive Value (PPV) for biopsy-confirmed CIN2+ reflected a 65% improvement
in the PPV when compared to microscopic examination.
These data are consistent with the results of external retrospective
research studies that were presented in September at the European Congress of
Cytology in Paris. In these retrospective studies from the Johns Hopkins
Medical Institutions and the Massachusetts General Hospital, the results
demonstrated an improvement of 70.6% and 95%, (p=0.0015, p=0.0002),
respectively, in sensitivity for detection of biopsy evidence of CIN2+ and an
improvement of calculated Positive Predictive Value of 113% and 136%,
respectively, when compared to microscopic examination.
“The results of our relatively large retrospective study with RUO reagents
incorporating the ProEx C biomarkers are wholly consistent with previously
reported results,” said Johnny Powers, PhD., Senior Vice President, TriPath
Oncology. “These research studies further demonstrate the correlation between
detection of aberrant S-phase induction with our ProEx C biomarkers and biopsy
evidence of high grade cervical disease.”

External and In-House Research Studies Address Analytical Performance,
Workflow, Impact on Microscopic Examination, and Specific Biomarker
Performance
In addition to the large retrospective in-house study, six additional
studies were presented at the ASC meeting. Investigators from the Johns
Hopkins Medical Institutions and the University of Colorado reported virtually
no variability with regard to scoring and staining reproducibility when using
a “home brew” version of the ProEx C Analyte Specific Reagent (ASR). These
researchers further concluded that their “home brew” assays were unaffected by
routine laboratory environment factors in these studies. In a separate study,
investigators from Johns Hopkins Medical Institutions observed that testing
with the ProEx C biomarkers may assist with the detection of cytologic
abnormalities on microscopic examination. Studies from the Company’s in-house
research staff addressed assay automation and the performance of specific
constituent biomarkers.
“We are very pleased with the results of these very practical studies,”
said Timothy Fischer, TriPath Imaging’s Vice President of Product Development.
“These studies provide early validation of our efforts to develop a product
that will be robust, easy to use and can be readily introduced into the
routine laboratory setting. Analytical performance and adaptability to routine
laboratory workflow will be critical determinants of the commercial success of
our products.”

About the ProEx C Biomarkers
The ProEx C biomarkers are monoclonal antibodies that detect over-
expression of proteins that is associated with aberrant S-phase induction, an
abnormal growth state that has been associated with cancer of the cervix,
esophagus, skin, prostate, ovary and colon. These biomarkers were identified
as the result of an outcome driven gene discovery analysis of cervical
neoplasia that was completed in 2003.

Analyst Day
Immediately following its third quarter earnings conference call on
November 10th, the Company will host an Analyst Day conference in New York
City. Management will review the results of research studies employing the
Company’s ProEx C molecular markers that were presented in conjunction with
the October meeting of the European Congress of Cytology in Paris and the
November meeting of the American Society of Cytopathology in San Diego. This
review will include the results of studies performed by investigators from
three major academic centers as well as the results of new in-house research
studies. The Company will also review the potential clinical and commercial
value of its developing pipeline in the area of molecular diagnostic products
and imaging systems.

TriPath Imaging, Inc., headquartered in Burlington, North Carolina,
develops, manufactures, markets and sells innovative solutions to improve the
clinical management of cancer, including detection, diagnosis, staging and
treatment. TriPath Oncology, a wholly owned subsidiary of TriPath Imaging,
develops molecular diagnostic products for malignant melanoma and cancers of
the cervix, breast, ovary and prostate. For more information on TriPath
Imaging please visit our web site at http://www.tripathimaging.com.

Investors are cautioned that statements in this press release that are not
strictly historical statements constitute forward-looking statements which
involve risks and uncertainties that could cause actual results and outcomes
to differ materially from what is expressed in those forward-looking
statements. Such forward-looking statements include, without limitation, those
related to the development of the ProEx C biomarker and the analyte specific
reagent for detection of aberrant S phase induction. Important factors that
may affect such forward-looking statements include, without limitation:
TriPath Oncology may be unable to successfully develop and commercialize
products and services when anticipated, if at all; clinical trials may yield
results for product candidates incorporating the ProEx C biomarkers that
differ from the results of our in-house and external research studies; TriPath
Imaging’s products may not achieve or maintain market acceptance to the degree
anticipated; TriPath Imaging and TriPath Oncology’s products may not receive
FDA or other required regulatory approval when expected, if at all; and other
risks detailed in TriPath Imaging’s filings with the Securities and Exchange
Commission, including those described in TriPath Imaging’s Annual Report on
Form 10-K for the year ended December 31, 2004.

Contact
Stephen P. Hall, Chief Financial Officer
TriPath Imaging
336-290-8721