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.
