PAXgene® Blood RNA System Receives Marketing Clearance from FDA for Use on QIAcube®
Solution standardizes blood collection, stabilization and purification
Venlo, The Netherlands - Mar. 4, 2009 - PreAnalytiX GmbH, a QIAGEN/BD Company, has received marketing clearance from the U.S. Food and Drug Administration (FDA) for the automation of the PAXgene Blood RNA System on the QIAcube. This clearance enables laboratories to automate, for the first time, an IVD purification method which is part of an integrated IVD blood collection method for intracellular RNA. The PAXgene Blood RNA System is the only collection, stabilization, and purification method, automated or manual, available now in the US for IVD use. Automation accelerates processing, increases capacity and helps to standardize processes in the laboratory thus reducing the potential for human error. It also reduces the risk of user-to-user variability, and minimizes manual tasks performed by technicians allowing them to focus time on other activities.
When blood is collected in a lab, clinicians and researchers are challenged by variations in expression profile and sample degradation which can be caused by sample collection, storage and transport conditions. Some genes may be up- or down-regulated resulting in gene expression profiles becoming altered after the point of collection. This can significantly alter the patient profile from what it was in vivo to what is seen at the point of analysis.
The PAXgene Blood RNA System is the only product designed to stabilize whole blood in the tube at point of collection with CE-mark and FDA marketing clearance. The standardization and stability it provides is especially important in clinical situations where multiple sites, transport times, and reproducibility are key issues. The PAXgene blood collection tube contains a proprietary reagent which immediately stabilizes intracellular RNA for up to three days at room temperature, and up to 50 months at -20 to -70º C. The ability to store and archive samples minimizes the urgency to process them, thus greatly enhancing lab efficiency.
The PAXgene purification process is designed to provide high quality intracellular RNA from samples stabilized in the PreAnalytiX reagent. Using the PAXgene Blood RNA System on the QIAcube provides customers with a completely integrated, automated approach to RNA purification.
"Combining the PAXgene Blood RNA System with the convenience and standardization achieved by automation on the QIAcube creates a new opportunity for our customers in CROs, Pharma, clinical laboratories and research institutions," says Peer Schatz, CEO, QIAGEN. "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."
The PAXgene Blood RNA Kit (50) is available in the US and Canada as version 762164, and in other countries as CE version 762174. The handbook is available as part of the kit, as well as available for free download at http://www.qiagen.com/. The protocol required to automate the PAXgene Blood RNA System on the QIAcube is also available for download free-of-charge by going to the company's website.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.