The MESOMARK® Assay
Recently, the U.S. Food and Drug Administration (FDA) approved the MESOMARK assay for use as an aid in the monitoring of patients with epithelioid and biphasic malignant mesothelioma. The test has been approved as a Humanitarian Use Device (HUD), which requires that additional regulations be followed by physicians ordering the test.
MESOMARK is an Enzyme-Linked Immunosorbent Assay (ELISA) for the quantitative measurement of Soluble Mesothelin-Related Peptides (SMRP) in human serum. As such, this test is authorized by federal law for use as an aid in monitoring patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data. MESOMARK is approved for distribution in the United States by the FDA as a HUD and as such, its effectiveness has not been demonstrated.
Visit the MESOMARK website for more information.