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MESOMARK® Approved for Humanitarian Use in the U.S.

Fujirebio Diagnostics, Inc., has received Humanitarian Use Device (HUD) approval for MESOMARK from the U.S. Food and Drug Administration (FDA). HUDs are approved for U.S. marketing based upon a claim that less than 4,000 individuals in the United States per year are affected by the medical condition as specified in the labeled indication for the device. 

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.   

Institutional Review Board (IRB) review and approval is required in order to use a HUD. Fujirebio Diagnostics has contracted with a national IRB to provide regulatory oversight for MESOMARK. 

After completing a brief questionnaire, please print, sign and fax the questionnaire to Fujirebio Diagnostics at 610.240.3912. After fax receipt, you will be sent a package containing Patient Information Brochures and a Test Requisition Form. The questionnaire should take only 5 minutes. Please click here to proceed.