The Swiss-based company PreAnalytiX GmbH is an equally-owned, worldwide joint venture between QIAGEN and Becton, Dickinson and Company (BD). PreAnalytiX develops, manufactures and markets integrated and standardised systems for sample collection, stabilisation and purification of high-quality RNA, microRNA and DNA from human blood, bone marrow, or tissue specimens. The Company serves healthcare institutions, academic researchers, clinical laboratories and the pharmaceutical industry with a broad array of manual and automated products.
One core competency of PreAnalytiX is the development and manufacture of sample collection devices for molecular diagnostic applications, for use in health care systems, pharma- and biotechnological research and academia, for various human sample materials. Another core competency is the development of integrated systems for sample collection, transport and storage and extraction of biomolecular targets (RNA, DNA and proteins) for use in diagnostic applications.
PreAnalytiX has successfully developed pre-analytical systems for the in vitro molecular diagnostic market. The PAXgene Blood RNA system was the first system ever that was approved for the use in in vitro diagnostic applications based on cellular RNA from whole blood samples. The system received the CE-IVD mark and FDA 510(k) de novo clearance in 2005. The PAXgene Blood DNA Tube (IVD) to collect, anticoagulate, stabilise, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA, received CE-IVD mark and FDA 510(k) clearance in 2015.