A serum test for the presence of a mesothelioma called MESOMARK developed by Fujiribio Diagnostics is now available in the U.S. Fujiribio has signed an exclusive agreement with ARUP Laboratories to offer it to patients. Here is a description of the test from the Fujiribio web site:
The MESOMARK assay is a manual enzyme-linked immunosorbent assay for the quantitative measurement of Soluble Mesothelin-Related Peptides (SMRP). SMRP is a biomarker that is released into the bloodstream by mesothelioma cells. SMRP can be elevated years before an actual diagnosis of mesothelioma is made. By measuring the amount of SMRP present in the bloodstream, the MESOMARK assay will help physicians routinely monitor individuals with the greatest risk of developing mesothelioma due to asbestos exposure.
Here is a brief description of the mesothelioma:
Mesothelioma is a form of cancer that is almost always caused by previous exposure to asbestos. In this disease, malignant cells develop in the mesothelium, a protective lining that covers most of the body's internal organs. Its most common site is the pleura (outer lining of the lungs and chest cavity), but it may also occur in the peritoneum (the lining of the abdominal cavity) or the pericardium (a sac that surrounds the heart).
The Fujiribio web site contains the following warning: The MESOMARK assay is available in the United States for Humanitarian Use Only. Below is an explanation of the Humanitarian Device Exemption (HDE) copied from the FDA web site:
A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but exempt from the effectiveness requirements of sections 514 and 515 of the act....As defined in 21 CFR 814.3(n), a Humanitarian Use Device HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
Here is some data about the sensitivity and specificity of the test provided by the manufacturer:
- SMRP was significantly elevated in the serum of 37 of the 44 patients with proven mesothelioma compared to controls
- SMRP had a sensitivity of 84% for mesothelioma, and specificity of 100% compared to other pleural diseases.
As part of my research for this note, I came across The Mesothelioma Center web site which contains some very sophisticated medical information about the lesion, including a notice of a webcast of an extrapleural pneumonectomy (Brigham and Women's Hospital broadcasts complex lung cancer surgery over the Internet), an operation that may be performed on mesothelioma patients. One mild note of caution, however. After clicking through an advertisement on the home page for legal advice relating to asbestos-induced mesothelioma, the following information is displayed:
The Mesothelioma Center is brought to you by Goldberg, Persky & White P.C., one of the first law firms in the United States to successfully take on the asbestos industry.
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