Test Associated with Changes in Treatment Management in 65% of Patients with Difficult-to-Diagnose Cancers

Redwood City, CA - Pathwork Diagnostics, Inc., a pioneer in creating genomics-based diagnostics in oncology utilizing their proprietary informatics platform, announced today that results from a patient registry study involving its Pathwork Tissue of Origin Test will be presented this week at the American Society of Clinical Oncology (ASCO) 2012 Gastrointestinal Cancers Symposium (January 19-21, San Francisco).

In the study, physicians who received the results of the Tissue of Origin Test for patients with difficult-to-diagnose primary cancers changed the working diagnosis 50% of the time and changed the treatment 65% of the time.
Published systematic reviews of studies in which patients received treatments without established cell origin suggest that chemotherapy leads to survival of approximately 9 months from the date of diagnosis, with less than 20% of patients alive at 2 years. In this study, median survival for all patients from time of biopsy was 14 months, with approximately 30% of patients alive at nearly 3 years.

The Pathwork Tissue of Origin Test is the only FDA-cleared, Medicare-covered molecular diagnostic for identifying tissue of origin. It uses a tumor's own genomic information to help pathologists and oncologists in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history.

"In this registry study, the Tissue of Origin Test led to both a change in working diagnosis and a change in treatment recommendations in over half the patients," explained J. Scott Nystrom, M.D., Chief of Clinic Operations, Division of Hematology/Oncology at Tufts-New England Medical Center and one of the investigators. "Survival outcomes compare favorably to historical controls in treatment trials where median survival is generally less than one year."

The study, "Changes in management and survival outcomes for patients receiving gene-expression-based tissue-of-origin test results for difficult-to-diagnose primary cancers," was authored by John C. Hornberger, Gauri R. Varadhachary, Hialy R. Gutierrez, William David Henner, Shawn Becker, Mahul Amin and J. Scott Nystrom (Poster presentation Saturday, January 21, 12:30 - 2:30 pm, Level 1, West Hall, The Moscone West Building, San Francisco).

About the Pathwork Tissue of Origin Test

The Pathwork Tissue of Origin Test, available through the Pathwork Diagnostics Laboratory, measures gene expression levels of 2,000 genes and uses proprietary algorithms to compare the tumor's gene expression pattern to that of 15 tumor types, representing 58 morphologies and 90% of all solid tumors. The test provides objective genomic information to help the physician diagnose what type of cancer the patient has. An accurate diagnosis allows oncologists to match therapy to the cancer.

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