This article has been updated to clarify that Qiagen's joint venture PreAnalytix received the FDA clearance, and not Qiagen.
NEW YORK (GenomeWeb News) – PreAnalytix, a joint venture of Qiagen and Becton Dickinson, has received US Food and Drug Administration clearance for the automation of the PAXgene Blood RNA System on Qiagen's QIAcube platform.
The system automates an in vitro diagnostic purification method for intracellular RNA. According to Qiagen, the PAXgene system is now the only collection, stabilization, and purification method — either automated or manual — available in the US for IVD use.
Qiagen believes the system will help overcome the challenges of variations in expression and sample degradation caused by sample collection, storage, and transport.
"The automated system will allow clinicians to obtain a gene expression profile even closer to the patient's true profile, facilitating the emerging use of gene expression signatures and messages in in vitro diagnostics and ultimately the improvement of patient care," Qiagen CEO Peer Schatz said in a statement today.
The PAXgene system was previously CE-marked in Europe.