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Patients & Family


What is the MESOMARK® test?
What is a Humanitarian Use Device (HUD)?
Why do I need to complete certification to order the MESOMARK test?
How do I get certified?
Where can I obtain additional information about the MESOMARK test?


What is the MESOMARK test?
The MESOMARK test is a blood test that measures Soluble Mesothelin-Related Peptides (SMRP) and may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. SMRP is a biomarker produced by the mesothelioma cells that can be elevated in the serum of patients suffering from mesothelioma. 

What is a Humanitarian Use Device (HUD)? 
An HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. 

Why do I need to complete certification to order the MESOMARK test?
The Food and Drug Administration (FDA) requires that the use of products approved as an HUD must be completed under an Institutional Review Board (IRB) approved protocol, in which each physician is considered a testing site. To comply with this regulation, Fujirebio Diagnostics has set up a protocol through a national independent IRB. This approved protocol will cover physicians throughout the U.S. for the use of the MESOMARK test and the certification will allow us to track for the FDA the “sites” that are using the test.

How do I get certified?
To become certified you must read and complete the certification questionnaire. After completing the questionnaire online, please print and sign the questionnaire and fax to Fujirebio at 610.240.3912. You will then receive a package containing Patient Information Brochures for distribution to patients who will receive the MESOMARK test. 

Where can I obtain additional information about the MESOMARK test?
To learn more about the MESOMARK test or for additional information, please contact Fujirebio Diagnostics, Inc. at 1-800-342-9225 or click here to contact us by email.