Roche has introduced a new real-time polymerase chain reaction-based cytomegalovirus (CMV) test in the US, for use on the company’s COBAS AmpliPrep/COBAS TaqMan system to quantify the DNA of the potentially deadly virus.
The fully automated system combines the COBAS AmpliPrep instrument for automated sample preparation, and the COBAS TaqMan analyser for automated real-time PCR amplification and detection.
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The COBAS system has parallel processing with other molecular diagnostics assays to detect Hepatitis B, Hepatitis C and Human Immunodeficiency viruses.
The information provided from the CMV test will help physicians to manage patients who have been diagnosed with CMV, specifically patients with an immune system that has been suppressed for solid organ transplantation, and who were undergoing anti-CMV therapy, according to the company.
Roche Diagnostics molecular diagnostics senior vice president Whitney Green said with the new test provides a standardised, FDA-approved option for CMV viral load testing that addresses a key medical need for transplant patients.
“There has been significant interest in the test from labs and the transplant community since the FDA approval, as it will provide physicians with clinically useful information to help them manage patients with CMV disease,” Green said.
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By GlobalDataImage: Roche headquarters in Basel, Switzerland. Photo: Courtesy of F Hoffmann-La Roche Ltd.
