FDA Approves MESOMARK Test
The United States Food and Drug Administration (FDA) has approved the sale of the MESOMARK® Assay, the world’s first in vitro test for managing patients with mesothelioma. The test was designed and manufactured by Fujirebio Diagnostics, Inc. of Malvern, PA. The test is also currently being evaluated in Europe and awaiting approval there.
According to a press release on Business Wire, the test is now available to physicians throughout the United States and will be used for monitoring patients who have been diagnosed with epithelioid or biphasic mesothelioma. With just a simple blood sample, the MESOMARK test will assist doctors in gauging the stages of mesothelioma and the progression of the disease in a particular patient.
Doctors and researchers agree that this new test will be significant in managing mesothelioma, as diagnosis and monitoring of the disease remain difficult despite extensive research in recent years. The MESOMARK will also be less invasive and much less expensive than current diagnostic and monitoring methods.
Technically speaking, the MESOMARK assay “is a manual enzyme-linked immunosorbent assay (ELISA) that identifies a group of molecular markers called soluble mesothelin-related proteins (SMRP). Released into the bloodstream by mesothelioma cells, elevated levels of these proteins are found in cancer patients,†explains the test’s manufacturer.
The approval was given under the FDA’s Humanitarian Device Exemption (HDE) program, which authorizes companies to market medical devices to treat or diagnose diseases which meet certain criteria.
