Medical Letter on the CDC & FDA
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Diagnostics
FDA clears genetic probe test for bone marrow transplant patients
February 20th, 2005
Applied Imaging Corp. (AICXE) announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its automated application for Chromosome X and Chromosome Y analysis in bone marrow transplant patients. Applied Imaging's CytoVision system will utilize this application to enumerate tests that are important indicators in evaluating the viability of opposite-sex bone marrow transplants. Bone marrow transplantation is an important therapeutic strategy in the management of a number of leukemias and other blood-based cancers. This new CytoVision application uses fluorescence in situ hybridization (FISH) technology to...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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