Progress on Mesothelioma Assay

A new assay that measures soluble mesothelin-related (SMR) proteins in serum in order to diagnose mesothelioma will enter clinical testing in the fourth quarter of 2004.

The assay, an enzyme-linked immunosorbent assay (ELISA), is being developed by Fujirebio Diagnostics, Inc. (Malvern, PA, USA). The company hopes to have the data needed by the U.S. Food and Drug Administration (FDA) in early 2005. If the FDA then clears the test, the market launch will take place later in 2005.

Since increased concentrations of SMR had been found in serum samples of patients with ovarian cancer, researchers at Fujirebio guessed that raised concentrations of SMR might also occur in the serum of patients with mesothelioma. The results of a study, using a double determinant ELISA on serum samples from 44 patients with mesothelioma, showed that 37 (84%) had raised concentrations, compared to only three (2%) of the 160 patients with other cancers or diseases, and none in 28 healthy controls not exposed to asbestos.

Mesothelioma is a cancer associated with asbestos exposure, for which there are currently no reliable serum tumor markers and few therapeutic options. In the U.S. alone, 10,000 workers exposed to asbestos die each year, and projections show that up to 10 times that many may die in the next decade. The new test could be used to screen people exposed to asbestos and aid the early diagnosis of the disease, as well as to monitor disease progression.




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Fujirebio Diagnostics, Inc