http://www.bizjournals.com/philadelphia/stories/2007/01/22/daily33.html?from_rss=1
A Philadelphia-area company got marketing approval Thursday for a blood
test for mesothelioma, a form of cancer liked to asbestos exposure.
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.