TriPath Imaging Receives FDA 510(k) Clearance for Ki-67 Application for Ventana Image Analysis System
April 17 2006 - 10:43AM
PR Newswire (US)
BURLINGTON, N.C., and TUCSON, Ariz., April 17
/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 Ki-67. In 2005, the
Companies announced 510(k) clearances for VIAS when used with the
Ventana Estrogen Receptor (ER), Progesterone Receptor (PR) and
HER-2/neu assays. Ki-67 is a cell proliferation biomarker which is
employed by pathologists as an adjunct to histopathology and is
used to assist with diagnosis and the prognostic assessment of
cancer. Precise quantitative measurement of Ki-67 expression in
breast biopsy samples may be used to calculate the rate of cell
proliferation by measuring the percentage of tumor cells that are
actively dividing and, therefore, producing more cancer cells.
Research studies have shown a significant correlation between high
proliferation rates and shorter disease free and overall survival.
VIAS is ideally suited to provide this level of biomarker
quantification. "FDA clearance for the analysis of Ki-67 clearly
increases the clinical utility of VIAS as an aid to the anatomical
pathologist. This is the first time the Ki-67 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 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 Ventana
Medical Systems Stephen P. Hall Christopher Gleeson Chief Financial
Officer President and CEO (336) 290-8721 (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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