FDA News

CISBIO Announces FDA Approval of MESOMARK

(March 26, 2007)--CISBIO,  developer of diagnostic assays for the quantification of tumor markers, announced that the MESOMARK Assay, the world’s first in vitro test for managing patients with mesothelioma, an aggressive and deadly form of cancer, has been approved by the FDA. The MESOMARK test is developed and manufactured by Fujirebio Diagnostics, Inc. of Malvern, PA; CISBIO is the exclusive distributor of MESOMARK in Europe, where it is currently undergoing evaluation for clinical use.

The MESOMARK test is now accessible to physicians across the U.S. for monitoring patients who have been diagnosed with epithelioid or biphasic mesothelioma. This minimally-invasive tool requires only a blood sample.

The transition of the MESOMARK test from research to clinical usage will be significant in managing mesothelioma, which mainly affects individuals who have been exposed to asbestos in the workplace. An estimated 10.000 new cases are diagnosed in industrialized countries each year. Although recent progress has been made in chemotherapy and surgical techniques for treatment, diagnosing and monitoring remain difficult. Current testing methods used to determine patient treatment can be invasive and costly.

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.

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.

Share or bookmarklet this web page at: