NEW YORK – An assay from Roche to test immunocompromised transplant recipients for adenovirus infections has been CE marked, the company announced on Wednesday. The test adds a fourth component to the firm's transplant monitoring virology menu and is now commercially available in countries accepting the CE mark.
The PCR-based adenovirus test provides detection and quantification of adenovirus, with calibration traceable to the World Health Organization international standard for adenovirus and reports in International Units per milliliter (IU/mL), the firm said in a statement.
The adenovirus test runs on the Roche Cobas 6800/8800 systems using the firm's Omni Utility Channel, which performs both open channel assays and Roche in vitro diagnostic tests. The 6800/8800 systems provide up to 96 results in about three hours and can execute up to three types of test in the same run with no presorting required.
"This new addition to our menu provides a more comprehensive solution for laboratories to offer improved monitoring tools so that treatment plans can be adjusted as necessary, providing better patient care," Mario Torres, head of Roche Molecular Diagnostics, said in the statement.