The firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.
The kit was previously approved by FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the automated QiaSymphony platform.
It is the first FDA-approved test for the stem cell transplant use case and meets the WHO International Standard for comparable results.
Following a beta evaluation of the system, a virology lab in Sheffield, UK, ran a workflow assessment and found improvements with the system.
The DxN Veris was recently launched as a CE-marked product with a menu of viral load tests, and will launch in a few years in the US with STD and HAI assays.
In PNAS this week: human cytomegalovirus diversity, patterns of homologous recombination in E. coli, and more.
A team of researchers has characterized the genomic diversity of the human cytomegalovirus and uncovered potential therapeutic targets.
The German firm has signed a deal for BL&H to distribute, market, and sell its T-Track CMV kit in South Korea once it is approved as an in vitro diagnostic.
The firm is pursuing CE-IVD clearance of the new platform populated with a menu of its MGB assays.
The qPCR-based test for the Cobas 6800/8800 systems meets WHO standards and is available commercially in markets recognizing the CE mark.
The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.
Using gene drives to control invasive species might be too risky, an initial advocate of the approach says.
In Science this week: intellectual property experts argue patent battles such as the one over CRISPR are wasteful, and more.
Researchers have grown tumors in 3D cell cultures to better understand cancer, the Economist reports.