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FDA Approves Abbott's Molecular CMV Assay

NEW YORK (GenomeWeb) – Abbott today announced the US Food and Drug Administration approved its RealTime CMV molecular test, the only commercially available cytomegalovirus test that can amplify two select regions of the CMV genome, according to the company.

The dual target capability of the assay reduces the risk of underquantitation or failure to detect the virus, a known concern with CMV infections because of possible mutations of the virus, Abbott said.

The test leverages PCR technology and is designed to be used on Abbott's m2000 RealTime platform. It is standardized against the First World Health Organization International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques, and is intended for use as an aid in managing hematopoietic stem cell transplant patients undergoing CMV treatment.

The test is also CE marked and available in Europe, the Middle East, Africa, Asia-Pacific, South and Central America, and other countries that recognize the designation.