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FDA Approves MESOMARK® Assay Test for Detecting Mesothelioma
WASHINGTON, DC — February 23, 2007 — MESOMARK®, a blood test for detecting mesothelioma, has been approved by the federal Food and Drug Administration. The manufacturer, Fujirebio Diagnostics, Inc. (Fujirebio), expects to have test kits available to doctors in the United States within the first quarter of this year through a central reference laboratory. MESOMARK® has already been marketed in Europe, New Zealand, and Australia.
MESOMARK® measures the blood serum concentrations of a marker called soluble mesothelin–related protein (SMRP), which are high in people who have mesothelioma. The patient provides a blood sample, which is sent to the laboratory for analysis. The laboratory determines the amount of SMRP in the blood by using monoclonal antibodies that bind to SMRP. Antibodies are proteins made by specialized white blood cells or lymphocytes that fight disease. Monoclonal antibodies are derived from a single, cloned antibody–producing cell.
Recent Study Shows Usefulness of MESOMARK®
The usefulness of the MESOMARK® assay was confirmed in a study published this month and discussed at the Society of Thoracic Surgeons Annual Meeting in San Diego, California. The researchers measured SMRP in 409 healthy individuals, in 177 people with illnesses other than cancer, and in 500 cancer patients, including 88 with mesothelioma. SMRP was increased in 52% of pleural mesothelioma patients and in 5% of individuals who were exposed to asbestos. SMRP levels in participants with other cancers or with non–cancerous conditions were lower and similar to those levels in healthy study participants.
Further studies are now underway to refine the MESOMARK® assay even further, and perhaps combine it with other tests. The study authors suggest also measuring osteopontin, a protein found in the blood that affects cell interactions and cell signaling. Osteopontin levels are generally high in mesothelioma patients.
Fujirebio suggests that MESOMARK® be used along with other procedures such as x–rays and patient history to diagnose and monitor mesothelioma. Increasing SMRP levels could indicate progressive disease, decreasing levels could show a positive response to mesothelioma therapy and constant results may be associated with stable disease (MESOMARK® FAQ).
Mesothelioma Diagnosis
Diagnosing mesothelioma is often difficult, since its symptoms are similar to those of other cancers. Also, mesothelioma takes decades to develop after the patient’s first exposure to asbestos, the substance that causes the cancer.
Currently, there is no cure for mesothelioma, although treatments such as surgery and chemotherapy may improve the quality of life and prolong survival. The hope is that MESOMARK® will allow doctors to diagnose mesothelioma at its early stages, when it may be more susceptible to treatment. “The MESOMARK® test may give physicians a way to determine how rapidly the disease is progressing and if they’re administering the appropriate treatment regimen,” commented Dr. W. Jeffrey Allard, Fujirebio’s vice president (Press Release, February 6, 2007). “In the future, our hope is that it could one day lead to detection of mesothelioma at an early and potentially curable stage.”
Your Mesothelioma Case
For further details about mesothelioma diagnosis, see Pleural Mesothelioma Diagnosis Can Be Complex. If you or a loved one has been diagnosed with mesothelioma, please feel free to contact us at Brayton Purcell to learn about your legal choices. We have been handling cases involving mesothelioma and asbestos exposure for over 24 years and can provide support, information, and excellent advocacy.
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