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CISBIO Announces FDA Approval of MESOMARK(R) Assay Now Availabe to Physicians in the U.S. for Monitoring Patients with Mesothelioma



    CISBIO, a developer and marketer of diagnostic assays for the
    quantification of tumor markers, announced that the MESOMARK(R) 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 United States Food and Drug Administration (FDA). The
    MESOMARK(R) test is developed and manufactured by Fujirebio
    Diagnostics, Inc. of Malvern, PA; CISBIO is the exclusive distributor
    of MESOMARK(R) in Europe, where it is currently undergoing evaluation
    for clinical use.

    The MESOMARK(R) 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(R) 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(R) 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.

    About CISBIO

    CISBIO develops, manufactures and markets diagnostic assays for
    the quantification of tumor markers and other biomarkers in clinical
    biology. European leader in nuclear medicine, CISBIO is also an
    established developer of technologies that are used in assay
    development and drug screening procedures to enhance drug discovery.
    The company produces a selection of biological reagents and methods
    used by pharmaceutical and biotechnology companies, as well as
    contract research organizations (CROs). Headquartered in Saclay,
    France, CISBIO is owned by the Belgium consortium RadioPharma
    Partners. For more information contact CISBIO on +33 (0) 169857325.

    MESOMARK(R) is a registered trademark of Fujirebio Diagnostics,
    Inc.