Press Room

March 26, 2013

bioTheranostics’ CancerTYPE ID® More Accurate than Immunohistochemistry in Diagnosing Metastatic Tumors

Study published in The Journal of Molecular Diagnostics supports the clinical utility of molecular classification in difficult-to-diagnose metastatic cancers

FOR IMMEDIATE RELEASE…March 26, 2013…SAN DIEGO…bioTheranostics’ CancerTYPE® ID molecular cancer classifier demonstrated superior accuracy compared with immunohistochemistry (IHC) in identifying the primary site in difficult-to-diagnose metastatic tumors. The comparative effectiveness study, which was published this month in The Journal of Molecular Diagnostics, is the first comprehensive investigation to directly compare the diagnostic accuracy of the two tumor classification techniques.

In this blinded study conducted in collaboration with the City of Hope National Medical Center, high-grade, primarily metastatic tumors considered diagnostically challenging were selected by lead investigators Lawrence M. Weiss, M.D., and Peiguo Chu, M.D. Performance of CancerTYPE ID for diagnosis of tumor type was directly compared with IHC analysis in 122 cases. Results were scored using reference diagnoses established by detailed clinical correlation.

More than 400,000 patients present with metastatic cancer each year in the United States. Metastatic cancers of unknown or uncertain primary origin pose significant challenges for physicians to select appropriate therapies. “Precision Medicine involves individualized patient care based on tumor biology,” said Richard Ding, CEO of bioTheranostics. “Timely, accurate, and definitive diagnosis is the critical first step, particularly as patient outcomes continue to improve with appropriate site-specific and molecular-targeted therapies. We are delighted to see CancerTYPE ID’s superiority in performance compared with the standard-of-care IHC.”

Ding said that this study, together with another recent study showing favorable survival outcomes when physicians use the molecular classifier to direct selection of site-specific therapy, supports the use of CancerTYPE ID as a standardized diagnostic tool in difficult-todiagnose metastatic cancers.

The study, “Blinded Comparator Study of Immunohistochemical Analysis versus a 92-Gene Cancer Classifier in the Diagnosis of the Primary Site in Metastatic Tumors,” can be accessed here. Preliminary results of the study were reported at the 2012 American Society of Clinical Oncology meeting.

About Biotheranostics

bioTheranostics, Inc., is the leading solution provider for metastatic cancer management, leveraging its unique expertise in gene expression profiling to develop a growing array of molecular diagnostic tests for cancer patients. The company operates a CLIA-certified, CAPaccredited diagnostic laboratory to perform its proprietary tests: the CancerTYPE ID® molecular classification test; PRÉCIS® Precision Medicine, which includes biomarker profiles for non-small cell lung, colorectal, and other cancers; and Breast Cancer IndexSM, which quantifies risk of recurrence of estrogen receptor-positive, lymph node-negative breast cancer. bioTheranostics, a bioMérieux company, is based in San Diego. Learn more at www.biotheranostics.com.