PAXgene Urine Liquid Biopsy Set with collection cup and a nucleic acid stabilizing tube enables non-invasive sample collection and direct cell-free DNA stabilization from urine // QIAGEN to commercialize set with the first verified, standardized and complete preanalytical workflow from urine collection, stabilization and isolation of cell-free DNA // Cell-free DNA in urine can provide important information to data not found in blood samples

PreAnalytiX GmbH, a joint venture between QIAGEN N.V. (NYSE: QGEN; Frankfurt, Prime Standard: QIA) and BD (Becton, Dickinson and Company; NYSE: BDX), today announced the launch of the PAXgene^® Urine Liquid Biopsy Set, which enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS). The new set will be commercialized by QIAGEN.

The PAXgene Urine Liquid Biopsy Set addresses the challenge of gaining access to cfDNA from urine through an integrated preservation solution. This easy-to-use set for urine collection and cfDNA stabilization is also the first to feature a verified, standardized and complete preanalytical workflow to make urine cfDNA more accessible than ever before for research analysis.

Urine cfDNA holds great promise for research and future clinical applications. It allows to measure and analyze cfDNA fragments, detect genetic modifications and mutations, determine the methylation status, and generate genomic data not found in blood samples. However, analyzing these samples has been challenging, because cfDNA quickly degrades after sample collection and can release misleading genomic DNA.

“Cell-free DNA isolated from urine offers a truly non-invasive sampling method for liquid biopsy, but urine cfDNA requires careful sample handling,” said Dr. Ellen Heitzer, Professor at the Medical University of Graz in Austria. “The PAXgene Urine Liquid Biopsy Set enables standardized urine sampling that is easy to use in clinical practice. It is compatible with various downstream analyses including hotspot, gene panel, and genome-wide analyses – all of which can provide important complementary information to blood.”

Dr. Uwe Oelmueller, PreAnalytiX Management Committee Co-Chair and Head of MDx Development Sample Technologies at QIAGEN, commented: “With the innovative PAXgene Urine Liquid Biopsy Set, we are excited to address a pressing market need for a urine collection, stabilization, transport and storage device that is integrated into a complete preanalytical workflow for the development of cfDNA-based tests. Liquid biopsies have huge potential, but accurate results are highly dependent on the workflow. As a result, the stabilization of analyte profiles in samples is critical to ensure that test results are reliable and reproducible."

The PAXgene Urine Liquid Biopsy Set represents a leap forward in sample quality, standardization and convenience for researchers working with urine samples. It offers a closed configuration set for urine collection and cfDNA stabilization, providing a range of options for sample shipment and storage conditions. It can be integrated into established workflows and is compatible with gold standard sample preparation products from QIAGEN. Developed according to Europe's latest CEN/TS standard for preanalytical handling of urine for isolated cell free DNA, the set offers an optimized and standardized workflow. The CEN/TS designation refers to Technical Specifications developed by the European Committee for Standardization (CEN).

Urine liquid biopsy has a significant potential to help researchers detect minimal residual disease, monitor treatment response and identify therapeutic targets by complementing the results of blood plasma analysis and providing a more complete understanding. However, unlike for blood samples, there have been no widely established technical solutions for the collection, storage, transport and processing of urine samples – a gap the PAXgene Urine Liquid Biopsy Set will now fill.

The new PAXgene Urine Liquid Biopsy Set will complement other liquid biopsy solutions commercialized by QIAGEN, covering all analytes (circulating cell-free nucleic acids, tumor cells, exosomes) and most molecular detection technologies (NGS, qPCR, digital PCR) to empower researchers and clinicians to fully realize the potential of liquid biopsy across various applications.