Roche has unveiled a new real-time polymerase chain reaction-based cytomegalovirus (CMV) test in the US.
The CMV test is designed for use on the company’s COBAS AmpliPrep/COBAS TaqMan system, which combines the COBAS AmpliPrep instrument for automated sample preparation and the COBAS TaqMan analyzer or the smaller COBAS TaqMan 48 analyzer for automated real-time PCR amplification and detection.
The COBAS AmpliPrep/COBAS TaqMan system, which also combines with the cobas p 630 instrument providing an integrated pre-analytical primary tube handling solution, has parallel processing with other molecular diagnostics assays to detect Hepatitis B, Hepatitis C and Human Immunodeficiency viruses.
The company said the information provided from the test will help physicians for managing patients who have been diagnosed with CMV disease, specifically patients with an immune system that has been suppressed for solid organ transplantation and who were undergoing anti-CMV therapy.
Roche Diagnostics molecular diagnostics senior vice president Whitney Green said with the new test, diagnostic laboratories now have a standardized, 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 added.