February 5, 2002
TriPath Oncology, Inc. and AmeriPath, Inc. Sign Letter of Intent
FOR IMMEDIATE RELEASE
Contact: Gregory A. Marsh Vice President & CFO AmeriPath,
Inc. 561-712-6211 E-mail: gmarsh@ameripath.com
Michelle D. Getty Investor Relations AmeriPath, Inc. 561-712-6260
E-mail: invrel@ameripath.com
Dennis M. Smith, Jr., MD EVP of Genomic Strategies and Chief Medical
Officer AmeriPath, Inc. 904-391-1345 E-mail: dsmith@ameripath.com
TRIPATH ONCOLOGY, INC. AND AMERIPATH, INC. SIGN LETTER OF INTENT
TO VALIDATE AND UTILIZE MELANOMA GENE ASSAY
- The Companies to Complete Agreement and Begin Validation and
Clinical Use of Novel Gene Expression Assay -
Riviera Beach, FL, February 5, 2002 – AmeriPath, Inc. (Nasdaq:
PATH), a leading national provider of cancer diagnostics, genomic,
and related information services, today announced that it has executed
a letter of intent to collaborate with TriPath Oncology, Inc. (“TriPath
Oncology”), a wholly owned subsidiary of TriPath Imaging,
Inc. (Nasdaq: TPTH) on the validation and clinical use of a novel
gene expression assay for malignant melanoma. TriPath Oncology
was established in July 2001 to manage the TriPath’s development
and commercialization efforts in connection with agreements with
BD (Becton, Dickinson and Company, NSE: BDX) to develop and commercialize
molecular diagnostics and pharmacogenomic tests for cancer.
According to the terms of the letter of intent, AmeriPath will
validate reagents and procedures developed by TriPath Oncology
to incorporate a novel gene target for malignant melanoma. The
assay will be performed on TriPath Imaging’s proprietary
Extended Slide WizardTM imaging and telepathology platform. TriPath
Imaging has developed a software module to support analysis of
the targeted gene expression in tissue obtained from skin biopsies
performed for the diagnosis of malignant melanoma. Finalization
of these arrangements remains subject to various authorizations
and approvals, as well as the negotiation and execution of a definitive
agreement, and is expected to be completed within 90 days.
“We are very pleased to be working with the leading provider
of dermatopathology services in the U.S.,” commented Paul
R. Sohmer, M.D., Chairman, President and Chief Executive Officer
of TriPath Imaging. “Our relationship with AmeriPath represents
a significant step toward providing broad market accessibility
to novel markers for malignant melanoma. In addition, the development
of a proprietary software application for assessing gene expression
levels in biopsy specimens further demonstrates the value of our
imaging technology and the Extended Slide WizardTM platform in
cell-based pathology and cancer diagnostics. This is a significant
milestone for TriPath Oncology in connection with its agreements
with Becton, Dickinson and Company (“BD”) to develop
and commercialize molecular diagnostics and pharmacogenomic tests
for cancer.
“This collaboration with TriPath Oncology related to its
novel gene expression assay for melanoma represents a wonderful
match between our companies,” said Dennis M. Smith, Jr.,
M.D., Executive Vice-President of Genomic Strategies and Chief
Medical Officer at AmeriPath. “As the market leader in dermatopathology,
we will leverage our unparalleled access to tissue and the collective
knowledge base of our Dermatopathology Resource Committee to develop
appropriate studies to expand further the clinical applications
of this unique assay. This test fits perfectly within our repertoire
of technologies at our Center for Advanced Diagnostics (CAD). The
fact that TriPath Oncology and BD, significant players in the diagnostic
manufacturing industry, sought out AmeriPath for this agreement
further validates the business model that we have built at CAD.”
The American Cancer Society estimates that in 2001 approximately
51,400 new cases of malignant melanoma will have been diagnosed
in the U.S. Although melanoma accounts for only 5% of all skin
cancers, it is responsible for more than 75% of deaths from skin
cancer. The American Cancer Society estimates that approximately
7,800 persons will have died from melanoma in 2001.
TriPath Oncology, a wholly owned subsidiary of TriPath Imaging,
Inc., develops molecular diagnostic and pharmacogenomic tests for
malignant melanoma and cancer of the prostate, colon, breast, ovary
and cervix.
AmeriPath is a leading national provider of cancer diagnostics,
genomics, and related information services. During the first nine
months of 2001, AmeriPath diagnosed approximately 2.9 million tissue
biopsies, and interpreted approximately 1.6 million Pap smears.
The company’s extensive diagnostics infrastructure includes
over 400 pathologists and doctorate-level scientists providing
services to 42 independent pathology laboratories, more than 200
hospitals, the Center for Advanced Diagnostics (CAD) and Dermpath
Diagnostics, a division of AmeriPath. CAD provides specialized
diagnostic testing and information services including Fluorescence
In-Situ Hybridization (FISH), Flow Cytometry, DNA Analysis, Polymerase
Chain Reaction (PCR), Molecular Genetics, Cytogenetics and HPV
Typing. AmeriPath has over 60 board-certified dermatopathologists
supporting Dermpath Diagnostics, one of the country’s leading
providers of dermatopathology services in the growing skin diagnostic
market. Additionally, AmeriPath provides clinical trial and research
development support to firms involved in developing new cancer
and genomic diagnostics and therapeutics.
...............................................................................................................................
The statements contained in this press release
include "forward-looking
statements'' within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements - which are sometimes
identified by words such as "may", "should", "believe'', "expect'', "anticipate'', "estimate" and
similar expressions and which include any financial or operating
estimates, forecasts or projections - are subject to a number
of risks and uncertainties, many of which involve factors or
circumstances
that are beyond the Company's control. These risks and uncertainties
could cause actual results to differ materially from results
anticipated by forward-looking statements. These risks and uncertainties
include:
the extent of success of the Company's operating initiatives
and growth strategies; ability to manage growth; access to capital
on satisfactory terms; general economic conditions; terrorism
or
an escalation of hostilities or war; competition and changes
in competitive factors; federal and state healthcare regulation
(and
compliance); reimbursement rates under government and third party
healthcare programs and the payments received under such programs;
changes in coding; changes in technology; dependence upon pathologists
and customer contracts; the ability to attract, motivate, and
retain pathologists; labor, technology and insurance costs; marketing
and promotional efforts; the availability of pathology practices
in appropriate locations that the Company is able to acquire
on
suitable terms or develop; and the successful completion and
integration of acquisitions (and achievement of planned or expected
synergies).
The forward-looking statements in this press release are made
as of the date hereof based on management's current beliefs and
expectations,
and the Company undertakes no obligation to update or revise
any such statements. Further information regarding risks, uncertainties
and other factors that could affect the Company's financial or
operating results or that could cause actual results to differ
materially from those expected, estimated or anticipated are
included
in the Company's annual, quarterly, and other reports and filings
with the SEC.
