Malignant Pleural Mesothelioma

Company submits application to FDA for approval of MESOMARK blood test

Published in Medical Letter on the CDC and FDA, June 5th, 2005

Fujirebio Diagnostics, Inc., (FDI), an oncology-testing company, submitted a 510k application to the U.S. Food and Drug Administration (FDA) on April 29, 2005, for clearance of MESOMARK, a blood test for mesothelioma.

"We are pleased to bring this new and exciting diagnostic tool for monitoring mesothelioma before the FDA for review," said Paul Touhey, president and COO for FDI. "MESOMARK further demonstrates FDI's commitment to deliver novel, innovative, and noninvasive technologies that help patients and physicians better manage cancer."

MESOMARK, a manual enzyme-linked immunosorbent assay (ELISA), works by identifying serum tumor markers called...

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Source: Medical Letter on the CDC and FDA (2005-06-05)

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