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CISBIO Announces FDA Approval of MESOMARK® Assay Now Availabe to Physicians in the U.S. for Monitoring Patients with Mesothelioma
SACLAY, France--(BUSINESS WIRE)--CISBIO, a developer and marketer 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 United States Food and Drug
Administration (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
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
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® is a
registered trademark of Fujirebio Diagnostics, Inc.