FDA Approves New Mesothelioma Test

January, 2007 - Fujirebio Diagnostics, Inc. has introduced the world's first in-vitro test for mesothelioma, a form of cancer linked to asbestos exposure, and has received approval from the Food & Drug Administration (FDA) under the Humanitarian Device Exemption (HDE) program for the MESOMARK® Assay.  From a simple blood test, the MESOMARK® test enables doctors to monitor patients diagnosed with biphasic or epithelioid mesothelioma. The MESOMARK®, via a blood test, is making it possible to monitor response to treatment and to detect recurrence following treatments. To patients fighting this cancer, this is an important head start.

"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." said Dr. W. Jeffrey Allard, vice president and chief scientific officer of Fujirebio Diagnostics. He added, "The MESOMARK® test signifies the beginning of a new era in monitoring mesothelioma malignancies." A key to managing the disease is quantification of changes in tumor volume, in which current diagnostic tests are less than ideal.  This new product will provide a much needed tool for monitoring patient status. The plan is to collect additional data in the future to support the use of the test to not only monitor, but also detect mesothelioma.

The test will be available nationally to physicians, via a central reference lab, in the first quarter of 2007.

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