Publication Describes Capability of TriPath Imaging's Liquid Based Cytology System in Processing Specimens Containing Potential
May 04 2006 - 1:37PM
PR Newswire (US)
Study indicates that density gradient separation process employed
by SurePath(R) Liquid Based Pap test handled significantly greater
amounts of potentially obscuring blood than competing membrane
filtration method BURLINGTON, N.C., May 4 /PRNewswire-FirstCall/ --
TriPath Imaging, Inc. (NASDAQ:TPTH) today announced that
investigators from the Caritas St. Elizabeth's Medical Center and
Tufts New England Medical Center in Boston, Massachusetts have
reported the results of a study in which the gradient density
separation or Cell Enrichment(TM) process employed by the SurePath
liquid based cytology system capably handled significantly greater
amounts of potentially obscuring blood than the competing membrane
filtration method. The results of this study are presented in an
article entitled "Comparison of the effectiveness of two
liquid-based Papanicolau systems in the handling of adverse
limiting factors, such as excessive blood" that appears in a recent
edition of Cancer CytoPathology (Cancer Cytopathology February 25,
2006; vol 108:27-31). In the study, reported by Brenda J. Sweeney
et al, conditions of excessive blood were simulated and a prepared
suspension combining the cellular residue from fifteen SurePath
collection vials was used. The study results were that the SurePath
methodology preparations were uncompromised until reaching aliquots
of 1000 microliters to 3000 microliters of blood; whereas, the
competing membrane filtration-based methodology was severely
compromised by the addition of as little as one drop (50
microliters) to 100 microliters of the blood preparation. The
SurePath liquid based Pap test employs density gradient separation
and centrifugation, a Cell Enrichment process that facilitates the
separation of epithelial cells of interest from blood and other
obscuring materials. With the competing membrane filtration method,
the cells of interest are separated when the liquid collection
medium is drawn through a filter using negative pressure pulse.
"The ability to minimize the impact of blood and other potentially
obscuring materials is a key feature of our slide preparation
process and clearly differentiates the SurePath liquid based Pap
test," said Ray Swanson, TriPath Imaging's Senior Vice President of
Commercial Operations. "This effectiveness of our Cell Enrichment
process, particularly as it relates to the handling of adverse
limiting factors such as excessive blood, is well appreciated by
both our clinician and laboratory customers." In the study reported
by Sweeny et al, conditions of excessive blood were simulated by
adding sequentially increasing volumes of a red blood cell/buffy
coat mixture to liquid based cervical specimens. Test preparations
were developed by combining resuspended cellular residue from
SurePath gynecologic specimens with increasing volumes of the red
blood cell mixture and dispensing them into nine or ten vials
appropriate to each of the two methods. Cytology specimens were
processed using the SurePath density gradient system or the
competing membrane filtration method one day after blood was added.
The cellularity of the resulting slides and determination of slide
adequacy for cytologic assessment was then assessed by microscopic
examination. The authors noted that if processing by membrane
filtration occurred immediately after the addition of blood, the
negative impact of the addition of blood on slide adequacy was
slightly reduced. However, reduction in adequacy dramatically
increased over several hours. In comparison, with SurePath
processed slides storage time was not a factor in affecting
adequacy. Sweeney et al concluded the sharply contrasted results
demonstrate systemically a technical limitation of the competing
membrane filtration system in coping with excessive blood while
using the procedures in the approved labeling. Further
investigation of technological differences in liquid-based Pap
smear methodologies may yield additional data regarding specimen
adequacy. 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 market acceptance
of TriPath Imaging's products, 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. Contact Stephen P. Hall Chief Financial Officer
336-290-8721 DATASOURCE: TriPath Imaging, Inc. CONTACT: Stephen P.
Hall, Chief Financial Officer of TriPath Imaging, Inc.,
+1-336-290-8721 Web site: http://www.tripathimaging.com/
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