The Pathwork Tissue of Origin Test
The Pathwork Tissue or Origin Test uses a tumor's own genomic information to help health care professionals determine what type of cancer cells are present in a malignant tumor. Pathwork Diagnostics' first FDA-cleared test helped identify metastatic, poorly differentiated and undifferentiated cancer in frozen specimens. The FDA in 2010 cleared the Tissue of Origin Test for formalin-fixed, paraffin-embedded (FFPE) specimens, the most commonly available tissue specimen. Click here to learn more.
With some metastatic and poorly differentiated tumors, identifying the type of cancer present is complex and can make diagnosis and treatment difficult. The Pathwork Tissue of Origin Test uses microarray-based RNA profiling to compare the patient's specimen to a database of known tumor types. The accurate, reproducible results are evaluated by the physician in the context of the patient's clinical history and complementary diagnostics, such as immunohistochemistry. Pathwork has the only FDA-cleared molecular classification tests for helping identify metastatic, poorly and undifferentiated tumors.
Pathwork Diagnostics' plans to make IVD test kits available for use in pathology laboratories. If you are a pathologist interested in running the kit, contact us at busdev@pathworkdx.com so that we can keep you up to date on our plans.
Indications for Use
The Pathwork Tissue of Origin Test is an in vitro diagnostic intended to measure the degree of similarity between the RNA expression patterns in a patient's formalin fixed, paraffin embedded (FFPE) tumor and the RNA expression patterns in a database of fifteen tumor types (poorly differentiated, undifferentiated, and metastatic cases) that were diagnosed according to then current clinical and pathological practice. This test should be evaluated by a qualified physician in the context of the patient's clinical history and other diagnostic test results.
Limitations
The Pathwork Tissue of Origin Test is not intended to establish the origin of tumors (e.g. cancer of unknown primary) that cannot be diagnosed according to current clinical and pathological practice. It is not intended to subclassify or modify the classification of tumors that can be diagnosed by current clinical and pathological practice, nor to predict disease course or survival or treatment efficacy, nor to distinguish primary from metastatic tumor. Tumor types not in the Pathwork Tissue of Origin Test database may have RNA expression patterns that are similar to patterns in the database. Therefore, results cannot be used to distinguish tumor types in the database from tumor types not in the database.