FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors

Pathwork Diagnostics' Gene Expression Test Is the First to Receive FDA
Clearance for Diagnosis of Uncertain Tumors; Problem Affects 200,000 New U.S.
Cancer Cases Annually

SUNNYVALE, Calif., July 31 /PRNewswire/ -- Pathwork Diagnostics, Inc., a
molecular diagnostics company focused on oncology, today announced that the
U.S. Food and Drug Administration (FDA) has cleared its Pathwork(R) Tissue of
Origin Test for use in determining the origin of uncertain tumors. The test
analyzes a tumor's gene expression pattern to help pinpoint the source of
hard-to-identify tumors and is the first test of its kind to receive FDA
clearance. Up to an estimated 200,000 newly diagnosed cancer patients annually
in the U.S. may have a tumor for which the site of origin is uncertain after
the initial diagnostic workup.(1,2,3,4) The FDA's clearance underscores the
growing role that patients' genomic information can play in helping physicians
make better decisions.
"Knowing the primary tumor site with greater certainty enables more
appropriate cancer treatment. The growing trend in cancer care is the use of
therapies that target specific tissues and their genomic components, rather
than relying on a one-size-fits-all treatment approach," said Deborah J. Neff,
President and Chief Executive Officer of Pathwork Diagnostics. "We believe the
Pathwork Tissue of Origin Test will help provide more certainty in tumor
diagnosis, which will enable more patients to realize the benefits of this new
era in genomics-based diagnostics." The FDA-cleared Pathwork Tissue of Origin
Test will be available as an in vitro diagnostic (IVD) kit, meaning that
clinical laboratories can run the test themselves. The test is currently
available as a service through Pathwork's CLIA-certified laboratory.
The Pathwork Tissue of Origin Test uses a microarray to measure the
expression pattern, comprising more than 1,500 genes, in the uncertain tumor
and compares it to expression patterns of a panel of 15 known tumor types,
representing 60 morphologies overall, to help determine the tumor's origin. In
the in vitro diagnostics clinical validation study submitted to the FDA, the
test demonstrated 89 percent positive agreement (akin to sensitivity) with
available diagnoses and 99 percent negative agreement (akin to specificity).
The study consisted of 545 metastatic, poorly differentiated and
undifferentiated tumors that had been identified as one of the 15 tumor types
on the panel using existing methods.(5) The test demonstrated an average 94
percent overall concordance across four laboratories in a cross-laboratory
comparison study of 60 metastatic, poorly differentiated and undifferentiated
tissue specimens.(6)
"Hard-to-identify tumors are a significant clinical problem," said Dr.
James Abbruzzese, Professor of Medicine at M.D. Anderson Cancer Center. "They
are time-consuming and frustrating for both physicians and patients.
Accurately identifying a tumor's origin -- and thus knowing what kind of
cancer the patient has -- is necessary for beginning standard-of-care,
cancer-specific treatment per the National Comprehensive Cancer Network
Clinical Practice Guidelines. Knowing the tumor's origin can also enable
patients to get into -- and benefit from -- appropriate clinical trials."
Targeted cancer therapies can be effective even with metastatic tumors and
are generally tumor-specific (e.g., Herceptin(R) for breast cancer), requiring
identification of the primary tumor site or tissue of origin. Targeting
therapy to specific tumor types can allow patients to avoid the toxicity of
broader chemotherapy.
"Traditional tools used to identify tumors of uncertain origin include
imaging studies, such as CT scans and MRIs, as well as a thorough pathological
evaluation with immunohistochemistry and other techniques," said Federico
Monzon, M.D., Director of Molecular Diagnostics of The Methodist Hospital in
Houston. "However, for difficult cases the use of these complex iterative
techniques can often take weeks, and in some cases they still do not
definitively identify the tissue of origin. A gene expression test like the
Pathwork Tissue of Origin Test provides unique information and, based on this
data, it is reasonable to expect that it will improve the diagnosis of
uncertain primary tumors."
About Pathwork Diagnostics
Pathwork Diagnostics, Inc., based in Sunnyvale, California, develops and
commercializes high-value molecular diagnostics for oncology. The company
delivers FDA-cleared, microarray-based tests to clinical laboratories and also
provides diagnostic tests through its CLIA-certified laboratory. The company's
initial tests utilize Pathwork Diagnostics' proprietary analytics and a
companion Pathchip(R) microarray, which runs on the proven Affymetrix
GeneChip(R) System. The company's first test -- the Pathwork Tissue of Origin
Test -- is now FDA-cleared as an in vitro diagnostic kit. A functionally
equivalent version of the test is also available through Pathwork(R)
Diagnostics Laboratory. The test aids in determining a tumor's origin so that
standard-of-care, cancer-specific treatment can begin. For more information,
please call toll-free 1.877.808.0006 or visit http://www.pathworkdx.com.
All rights reserved. Pathwork, Pathchip, Pathwork Diagnostics, and the
Pathwork Diagnostics logo are trademarks or registered trademarks of Pathwork
Diagnostics, Inc. Other names may be the trademarks of their respective
owners.
(1) Pavlidis N, Fizazi K. Cancer of unknown primary (CUP). Crit Rev Oncol
Hematol. 2005;54(3):243-250.
(2) Tong KB, Murtagh KN, Hubert HB, et al. Incidence, costs of care and
mortality of Medicare beneficiaries diagnosed with cancer of unknown
primary origin. Poster presented at the annual meeting of the American
Society of Clinical Oncology; June 2-6, 2006; Atlanta, GA.
(3) Pathwork Diagnostics analysis.
(4) American Cancer Society, Cancer Facts & Figures 2008. Atlanta:
American Cancer Society; 2008.
(5) Pathwork Tissue of Origin Test User Guide (P/N 72912).
(6) Dumur CI, Lyons-Weiler M, Sciulli C, et al. J Mol Diagn.
2008;10:67-77.

SOURCE Pathwork Diagnostics, Inc.

Scott Shadiow of Pathwork Diagnostics, Inc., +1-415-515-0786,
media@pathworkdx.com