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About Mesomark

About Mesomark

Thank you for visiting the MESOMARK® assay website

We are pleased to announce that the FDA has 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.

As a part of the HUD designation the testing of patients must fall under an Institutional Review Board (IRB) approved protocol. Fujirebio Diagnostics, Inc., has received approval for this protocol through a national Independent IRB (IIRB). The IIRB requires physicians to become certified — done by completing a brief questionnaire — before they can order the test. Following certification, physicians will receive a packet containing information brochures to be distributed to every patient. If you would like to complete this questionnaire now and become a certified physician, please click here or call 1-800-342-9225 and speak with a customer service representative. 

Once certified, physicians are able to order the test for the monitoring of patients suffering from mesothelioma. All MESOMARK testing will be done at a national reference laboratory. 

Contact us for more information on how to order the test, or for information about mesothelioma click here.