At PreAnalytiX, we bring new technologies to our customers in the form of products that standardize the collection, preservation, and processing of biospecimens to provide the highest quality biomarkers for research and the diagnosis and treatment of human disease.
Our accomplishments are a testament to our dedication to innovation.
Launch of the PAXgene Saliva Collector, a non-invasive and painless method of sample collection. The PAXgene Saliva Collector is part of a standardized preanalytical workflow for human saliva collection, stabilization, transportation, and storage through nucleic acid extraction and analyses.
Launch of QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) together with PAXgene Blood ccfDNA Tubes (CE-IVD) as first products CE marked for In Vitro Diagnostic use according to the EU IVDR 2017/746. For automated purification of circulating, cell free DNA (ccfDNA) from plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) using the QIAGEN QIAsymphony SP instrument.
PreAnalytiX fulfilled the QMS requirements of the In Vitro Diagnostic Medical Device Regulation EU IVDR 2017/746 and successfully passed the EU Notified Body inspection of its Quality Management System (QMS) according to ISO 13485 and in compliance to the new EU IVDR 2017/746
Automate the PAXgene Blood RNA Kit (IVD) with launch of the QIAGEN QIAcube Connect MDx (IVD) Platform. The automated system can be used in combination with PAXgene Blood RNA extraction kits (FDA - Cat No. 762164)(CE-IVD – Cat No. 762174) therefore suitable for use in IVD workflows.
Launch in Europe of the PAXgene Blood ccfDNA Tube CE-IVD for the collection of whole blood and the stabilization of circulating cell-free DNA levels for use in diagnostic procedures.
Launch of the QIAsymphony PAXgene Blood ccfDNA Kit* for the automated purification of ccfDNA from plasma.
Launch of the PAXgene Blood ccfDNA Tube RUO* for the collection of whole blood and the stabilization of circulating cell-free DNA levels.
Launch of PAXgene Blood DNA Tube IVD for the collection of whole blood and the stabilization of DNA for use in vitro diagnostic (IVD) testing.
Launch in Europe of the PAXgene Blood DNA Tube CE, the first CE-IVD tube designed for the collection of whole blood and the stabilization of DNA for use in molecular diagnostic testing.
Launch of QIAcube protocols for the PAXgene Tissue RNA* and PAXgene Tissue DNA Systems,* enabling benchtop automation of RNA and DNA purification from tissue samples.
Launch of the PAXgene Tissue FIX Container,* expanding the PAXgene Tissue product portfolio to accommodate a broader range of tissues specimens.
Launch of the second-generation QIAsymphony PAXgene Blood RNA Kit* with improved RNA purification results that include miRNA.
The NIH Genotype-Tissue Expression Project (GTEx), which aims to systematically describe gene expression and regulation in multiple tissue types, chooses the PAXgene Tissue System for tissue collection over formalin and other molecular fixatives.
The PAXgene Blood RNA System** exceeds 1,000 references in peer-reviewed scientific articles.
Launch of the PAXgene Blood RNA System protocol for the QIAcube (IVD), for benchtop automation of RNA purification from blood samples.
Launch of the PAXgene Blood miRNA Kit* for the efficient purification of miRNAs from blood samples.
Launch of the PAXgene Tissue System*, the only product on the market that enables histological and molecular analysis of the same sample.
PreAnalytiX joins the SPIDIA consortium, an EU-funded project for the standardization and improvement of pre-analytical procedures in in vitro diagnostics.
Launch of the QIAsymphony PAXgene Blood RNA Kit*, enabling full automation of RNA purification from blood samples.
Launch of the PAXgene Bone Marrow RNA System*, designed to address the challenges of collecting, stabilizing, storing, and purifying RNA from bone marrow samples.
CE and 510(k) clearance for the PAXgene Blood RNA System, making it the first and only IVD system for the molecular diagnostic testing of RNA from whole blood.
Launch of the PAXgene Blood DNA System*, which includes the first tube developed for the collection, transport and storage of whole blood and the stabilization of DNA.
Launch of the PAXgene Blood RNA System,* the first integrated system for the collection, transport, and storage of whole blood and the stabilization and purification of intracellular RNA.
QIAGEN and Becton, Dickinson and Company form the PreAnalytiX joint venture.
* For Research Use Only. Not for use in diagnostics procedures.
** The PAXgene Blood RNA System is available for IVD use only with the PAXgene Blood RNA
Tube is used in combination with the PAXgene Blood RNA Kit (IVD)
