TriPath Imaging Receives FDA 510(k) Clearance for p53 Application for Ventana Image Analysis System
October 12 2006 - 3:22PM
PR Newswire (US)
BURLINGTON, N.C. and TUCSON, Ariz., Oct. 12 /PRNewswire-FirstCall/
-- TriPath Imaging Inc. (NASDAQ:TPTH) and Ventana Medical Systems,
Inc. (NASDAQ:VMSI), announced today that TriPath Imaging has
received 510(k) clearance from the U.S. Food and Drug
Administration for the Ventana Image Analysis System (VIAS(TM))
when used with tissues stained for p53. In 2005 and 2006, the
Companies announced 510(k) clearances for VIAS when used with the
Ventana Estrogen Receptor (ER), Progesterone Receptor (PR), Ki-67
and HER- 2/neu assays. p53 is a tumor suppressor biomarker which is
employed by pathologists as an adjunct to histopathology and is
used to assist with diagnosis and the prognostic assessment of
cancer. Research studies have shown that high expression levels of
the p53 protein have been associated with more aggressive breast
cancers. Precise quantitative measurement of p53 expression in
breast biopsy samples may be used to aid in the over-all management
and treatment selection of breast cancer patients. VIAS is ideally
suited to provide this level of biomarker quantification. "FDA
clearance for the analysis of p53 increases the clinical utility of
VIAS as an aid to the anatomical pathologist. This is the first
time the p53 marker has been cleared by the FDA for use with an
image analysis system," said Paul R. Sohmer, M.D., Chairman,
President, and CEO of TriPath Imaging. "We expect to continue to
further expand the application menu supported by VIAS with
additional 510(k) applications." "We are pleased that TriPath
Imaging has obtained this clearance," stated Christopher Gleeson,
President and Chief Executive Officer of Ventana Medical Systems.
"This expands our VIAS menu and, together with the previous
clearances for ER, PR, Ki-67 and HER-2/neu, enables us to provide
further value to pathologists." About TriPath Imaging, Inc. 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/. About Ventana
Medical Systems, Inc. Ventana develops, manufactures, and markets
instrument/reagent systems that automate slide preparation and
staining in clinical histology and drug discovery laboratories
worldwide. Ventana's clinical systems are important tools used in
the diagnosis and treatment of cancer and infectious diseases.
Ventana's drug discovery systems are used to accelerate the
discovery of new drug targets and evaluate the safety of new drug
compounds. TriPath Imaging Safe Harbor Statement 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 interactive histology imaging system, including
expected additional 510(k) applications, and product development
efforts. 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, 2005. Ventana Safe Harbor Statement
This press release contains certain forward-looking statements
within the meaning of the Federal Securities laws. These
forward-looking statements include, but are not limited to,
statements regarding the marketing of products and market
acceptance of Ventana products. These forward-looking statements
are subject to numerous risks and uncertainties, and actual results
may vary materially. A full discussion of risks and uncertainties
is available in our most recent Annual Report filed with the
Securities and Exchange Commission (SEC) on Form 10-K and all
subsequent SEC filings. Copies of filings made with the SEC are
available through the SEC's electronic data gathering analysis
retrieval system (EDGAR) at http://www.sec.gov/. We undertake no
obligation following the date of this release to update or revise
our forward- looking statements or to update the reasons actual
results could differ materially from those anticipated in
forward-looking statements. We caution you not to place undue
reliance upon any such forward-looking statements, which speak only
as of the date such statements are made. Past performance is not
indicative of future results. We cannot guarantee any future
operating results, activity, performance, or achievement. Contacts:
TriPath Imaging Stephen P. Hall Chief Financial Officer (336)
290-8721 Ventana Medical Systems Christopher Gleeson President and
CEO (520) 229-3787 Nick Malden Chief Financial Officer (520)
229-3857 DATASOURCE: TriPath Imaging, Inc. CONTACT: Stephen P.
Hall, Chief Financial Officer of TriPath Imaging, +1-336-290-8721;
or Christopher Gleeson, President and CEO, +1-520-229-3787, or Nick
Malden, Chief Financial Officer, +1-520-229-3857 , both of Ventana
Medical Systems Web site: http://www.tripathimaging.com/
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