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Fujirebo Diagnostics gets OK for test
A Philadelphia-area company got marketing approval Thursday for a blood test for mesothelioma, a form of cancer liked to asbestos exposure.
Philadelphia Business Journal
January 25, 2007
Fujirebio Diagnostics Inc., a subsidiary of Japanese company Fujirebio Inc., got Food and Drug Administration approval for its Mesomark assay test.
"The Mesomark test signifies the beginning of a new era in monitoring mesothelioma malignancies," said Dr. W. Jeffrey Allard, vice president and chief scientific officer of Fujirebio Diagnostics of Malvern, Pa. "As the first in-vitro test for patients with this aggressive disease, it will enable doctors to more accurately detect recurrence and monitor treatment of patients."
Mesothelioma affects the sac lining the chest, the abdominal cavity or the area around the heart.
Many people with this cancer have been employed in environments where they inhaled asbestos, such as in the shipbuilding and construction industries.
The test kit was developed to measure levels of a biomarker, mesothelin, in serum. Biomarkers are substances found in higher-than-normal concentrations in the blood, urine or body tissues of patients with certain types of cancers. The test may be used to monitor patients confirmed as having mesothelioma, for recurrence in patients following surgery, or for measuring response to therapies.
The company expects to have the test kits available nationally to physicians in the first quarter.