Redwood City, CA, January 19, 2012 – 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.1-5 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.
The Pathwork Tissue of Origin Test has been extensively evaluated in multiple independent studies involving more than 1,100 patient specimens, including large validation studies published in the Journal of Clinical Oncology and the Journal of Molecular Diagnostics.
A retrospective study of 111 cases from 66 academic and community oncology practices illustrates the use of the test in management of cancer patients. Over two thirds of the cases reviewed showed cancer management changed after the Pathwork Tissue of Origin Test result was received. The majority of the oncologists identified the Tissue of Origin Test results as influencing the decision to make a change in therapy.
About Pathwork Diagnostics
Pathwork Diagnostics created its proprietary informatics platform to develop and commercialize high-value, medically important diagnostics aimed at helping guide cancer care. Pathwork has commercialized its Pathwork Tissue of Origin product line, and has a robust pipeline and growing portfolio of pharmaceutical partners. Pathwork is privately held and based in Redwood City, CA. For more information call toll-free (877) 808-0006 or visit www.pathworkdx.com.
1. van de Wouw AJ, Janssen-Heijnen ML, Coebergh JW, Hillen HF. Epidemiology of unknown primary tumours; incidence and population-based survival of 1285 patients in Southeast Netherlands, 1984-1992. Eur J Cancer 2002;38:409-13.
2. Greco F, Hainsworth J. Introduction: unknown primary cancer. Semin Oncol 2009; 36: 6–7.
3. National Comprehensive Cancer Network: NCCN Guidelines on Carcinoma of Unknown Primary. Available at http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed August 2, 2011.
4. Altman E, Cadman E. An analysis of 1539 patients with cancer of unknown primary site. Cancer 1986; 57: 120-124
5. Markman M. Metastatic adenocarcinoma of unknown primary site: analysis of 245 patients seen at The Johns Hopkins Hospital from 1965--1979. Med Pediatr Oncol 1982; 10: 569-574.