bioTheranostics, developer of innovative oncology diagnostic tests and solution provider for metastatic cancer, today announced study results showing that tumor profiling with its CancerTYPE ID® molecular test helped guide site-specific chemotherapy and improve overall survival for patients with carcinoma of unknown primary site (CUP). The results were presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The prospective trial, led by John Hainsworth, M.D., and F. Anthony Greco, M.D., of the Sarah Cannon Research Institute, utilized the CancerTYPE ID molecular classifier on 252 previously untreated CUP patients. Of the 194 patients who received assay-directed first-line therapy, results showed that the median overall survival was 12.5 months versus 4.7 months for patients receiving empiric therapy (p=0.02).
"This was the first prospective study in which molecular profiling was used to direct site-specific therapy in CUP patients, producing a median overall survival that compares favorably with previous trials of empiric CUP therapy," said bioTheranostics Chief Scientific Officer Mark Erlander, Ph.D. "Importantly, evidence from this study supports the use of molecular tumor profiling in the standard management of patients with CUP."
Richard Ding, CEO of bioTheranostics, said this study demonstrates the diagnostic and therapeutic utility of CancerTYPE ID in CUP management. "These results show the value of CancerTYPE ID in improving treatment efficacy by directing site-specific therapy," he said. "The results strengthen the rationale for molecular profiling in CUP management and show the value of precision medicine."
Ding said the results of this study are supported by two other studies presented at ASCO. This includes the first study to compare molecular classification versus the standard-of-care immunohistochemistry (IHC), which showed that CancerTYPE ID has a higher level of diagnostic accuracy than IHC (Abstract #e21019) in a series of 122 difficult-to-diagnose cases. A second blinded, multi-institutional study with three centers of excellence (UCLA, Mayo Clinic, and Massachusetts General Hospital)—the largest validation study of a molecular classifier to date (Abstract #10588)—showed that CancerTYPE ID has a high level of accuracy in predicting main tumor type and subtype, as well as stable performance in primary versus metastatic tumors, and in samples where specimen quantity was limited, as is common with core and fine needle biopsies.
"Taken together, these results support the use of the CancerTYPE ID assay as a standardized diagnostic aid when primary tumor site is uncertain," Ding said. They also serve to solidify bioTheranostics' position as a partner and solution provider in metastatic cancer."
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