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Abbott CMV molecular test OK’d by FDA

July 6, 2017Abbott’s RealTime CMV molecular test received FDA approval and is now available in the United States. According to the company, it is the only commercially available cytomegalovirus test with the ability to amplify two select regions (dual target) of the CMV genome, which helps reduce the risk of under-quantitation or failure to detect the virus—a known concern with CMV infections due to the possibility of mutations.

The RealTime CMV test uses polymerase chain reaction technology and is designed for use on Abbott’s m2000 RealTime system. Standardized against the 1st World Health Organization International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques, the test is for use as an aid in the management of hematopoietic stem cell transplant patients undergoing treatment for CMV infections.

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

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