FDA Approves Assay for Monitoring Meso

January 30, 2007 - According to a press release issued on January 25, Fujirebio Diagnostics, Inc. (FDI) has received approval from the Food & Drug Administration (FDA) under the Humanitarian Device Exemption (HDE) program for the MESOMARK® Assay, the world's first in-vitro test for mesothelioma.

"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. "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."

Experts say the test may be used to monitor patients already diagnosed with mesothelioma, for recurrence in patients following surgery, or for measuring response to therapies like chemo or radiation.  FDI has announced that the test will be available nationally to physicians in the first quarter of 2007.

"Development of a reliable biomarker is a major advance in the care of mesothelioma," said Chris Hahn, executive director of the Mesothelioma Applied Research Foundation (Meso Foundation). "Fujirebio Diagnostics and the MESOMARK test are now making it possible - with a simple blood test -to monitor response to treatment and to detect recurrence following treatment. This provides an important head start to patients racing against this aggressive cancer."

Currently, notes the press release, more than 100 million people worldwide have been exposed to asbestos on-the-job over the years.  Those most affected include shipyard workers, insulators, boilermakers, plumbers and maintenance workers.  Most often, these workers were not aware of their exposure until long after they left their jobs or when they were ultimately diagnosed with an asbestos-related disease.  Companies often concealed the fact that their employees were dealing with hazardous materials and did not provide protective gear, such as masks, for their workers.

Fujirebio Diagnostics is located in Malvern, PA, near Philadelphia, and is an industry leader in the development of biomarkers – tests that detect the presence of cancer in the blood, urine, or tissue.