In recent years two companies have attempted to commercialize molecular diagnostic assays designed to provide clinicians improved information about cancers of unknown primary (CUP). The prognosis for CUP patients is particularly poor. Treatment options are limited as, by definition, patients present with metastatic disease, and because very little is known about the origin of the cancer. Both Pathwork Diagnostics Inc. and Rosetta Genomics Ltd. developed tests that use the molecular makeup of the cancer cells to provide insight on the cancer’s origin.
Pathwork Diagnostics’ test was cleared by the FDA in 2008 (for frozen samples) and again in 2010 (for formalin-fixed, paraffin-embedded...
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