New External Research Studies Indicate Strong Correlation of TriPath Imaging's ProEx C Biomarkers with Biopsy Evidence of High Grade Cervical Intraepi

TriPath Imaging, Inc.
(Nasdaq: TPTH) today announced that researchers from the Johns Hopkins Medical
Institutes and the Massachusetts General Hospital have reported preliminary
results from two retrospective research studies in which testing of cervical
cytology specimens with the Company's proprietary ProEx(TM) C biomarkers
yielded a 70.6% to 95% 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+, and a
greater than 110% improvement in calculated Positive Predictive Value for
detection of CIN2+ as compared to all atypical and abnormal cytology
classifications combined, defined as ASCUS and higher (ASCUS+).
Preliminary results from each of these two external research studies and
new in-house research studies utilizing the ProEx C biomarkers for testing of
cervical cytologic and tissue specimens were presented earlier today at the
31st European Congress of Cytology in Paris. The external research studies
were discussed in a Company sponsored satellite symposium held in conjunction
with the Congress.

About 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, prostrate, 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. For the purpose of the external research
and new in-house research studies discussed in Paris, the ProEx C biomarkers
were incorporated into Research Use Only 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.
"These preliminary results show the potential for improved detection of
underlying high grade cervical disease," said Dr. Johnny Powers, Senior Vice
President of TriPath Oncology. "As a next step, we are developing a reagent
formulation incorporating the ProEx C biomarkers that will be designed for use
in a general screening population and anticipate initiating clinical trials
with this primary screening formulation later this year."
The Massachusetts General Hospital and Johns Hopkins Medical Institutes
studies were designed to evaluate the performance of the ProEx C biomarkers in
retrospective research studies of 602 and 343 cervical cytology specimens,
respectively, in which the results of cervical tissue biopsies were known for
samples that had atypical and abnormal cytology results but masked for the
purpose of the study. The correlation between biopsy evidence of CIN2+ and
detection of ProEx C proteins using Research Use Only reagents was compared
with the correlation observed between biopsy evidence of CIN2+ and an atypical
or abnormal cytology classification based on evaluation of cytologic
morphology. For all atypical and abnormal cytology specimens (ASCUS+)
evaluated in these retrospective research studies at Massachusetts General
Hospital and Johns Hopkins Medical Institutes, the relative improvement in
calculated Positive Predictive Value for CIN2+ in corresponding biopsies was
136% and 113%, respectively, as compared to the cytologic morphology
evaluation.

Molecular Cytology Imaging System in Development
The studies conducted at the Massachusetts General Hospital also included
a preliminary evaluation of a prototype of the molecular cytology imaging
system that the Company is currently developing to identify and display ProEx
C positive cells within cytologic preparations. The investigators reported
very good agreement between manual and computerized screening and suggested
that the use of the molecular cytology imaging system facilitated the
identification of positive cases when only a small number of positive cells
could be found on a slide.
Dr. Powers added, "The combination of molecular behavior, cellular
morphology and high throughput automated imaging represents the next
generation of cervical disease screening."

In-House Research Studies Provide Early Evidence of Specificity of
Biomarkers
The Company also announced that the results of new in-house research
studies were presented at the Congress. Members of the Company's research
staff reported preliminary results from an ongoing prospective research study
in which the results obtained from testing of abnormal cytology specimens were
compared to those obtained from corresponding biopsies of cervical tissue.
The results obtained from the first 17 cases enrolled in this study were
addressed in this presentation. The ProEx C biomarkers were over expressed in
all 9 of the cytological and histological cases for which cervical biopsy
revealed CIN2+. Testing with the ProEx C biomarkers was negative in 7 of 8
cytological and histological specimens for which the biopsies revealed CIN1 or
less. The histopathologic interpretation of biopsied tissue from the one case
in the CIN1 group that was Pro Ex C positive for both cytology and histology
was equivocal and reported as "CIN1 cannot rule out CIN2". Protein over-
expression associated with aberrant S-phase induction as detected with the
ProEx C biomarkers was observed in all cervical cytology specimens in which
evidence of CIN2+ was found in corresponding tissue biopsies, demonstrating
strong agreement between the molecular testing and histological findings.
"These results are consistent with those that we have previously
reported," commented Dr. Douglas Malinowski, TriPath Imaging Vice President
and Chief Scientific Officer. "The finding that ProEx C staining was observed
in cytological and histological samples in which biopsy revealed a histologic
diagnosis of CIN2 or greater speaks to the potential specificity of these
biomarkers."

Additional Data to Be Presented at ASC Meeting in November
The Company confirmed that additional data from these and other external
and in-house research studies will be presented at the American Society of
Cytopathology meeting in early November. In addition, the Company will host an
Analyst Day conference on November 10th in New York City to review in detail
all of the research data accumulated to date and to discuss potential clinical
and commercial value of its developing pipeline in the area of molecular
diagnostic products and imaging systems.
We are obviously very pleased with the results reported in Paris," added
Paul R. Sohmer, M.D., Chairman, President and CEO of TriPath Imaging, Inc. "We
believe that these results further substantiate the correlation between
detection of the over-expression of proteins associated with aberrant S-phase
induction with our ProEx C biomarkers and CIN2+. We look forward to the
presentation of additional data at the American Society of Cytopathology
meeting and Analyst Day conference in November."

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 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; 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.

Contacts
Stephen P. Hall
Chief Financial Officer
(336) 290-8721

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