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Roche CMV test for HSCT patients approved in U.S.

May 25, 2016 6:45 AM ETRoche Holding AG (RHHBY) StockBy: Douglas W. House, SA News Editor
  • The FDA approves Roche's (OTCQX:RHHBY) cytomegalovirus (CMV) test specifically targeted to patients who have undergone a hematopoietic stem cell transplant (HSCT). The real-time polymerase chain reaction (PCR)-based assay is designed to use on the company's automated COBAS AmpliPrep/COBAS TaqMan System.
  • The test is intended for use as an aid in the management of solid-organ and HSCT recipients who are undergoing anti-CMV therapy. The quantitative test enables serial DNA measurements that can be used to assess virologic response to treatment.

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