Liquid Biopsy Solution Enables Non-Invasive Sample Collection and Direct Cell-Free DNA Stabilization from Urine

Urine cell-free DNA (cfDNA) presents significant potential for research and future clinical applications. It facilitates the measurement and analysis of cfDNA fragments, detection of genetic alterations, assessment of methylation status, and generation of genomic data that may not be obtainable from blood samples. However, analyzing urine cfDNA has posed challenges, as cfDNA degrades quickly after collection, potentially releasing contaminating genomic DNA. Now, an innovative solution enables non-invasive sample collection and immediate stabilization of cfDNA in urine, making standardized urine sampling practical for clinical use.

PreAnalytiX GmbH (Hombrechtikon, Switzerland), a joint venture between QIAGEN N.V. (Venlo, The Netherlands) and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA), has launched the PAXgene Urine Liquid Biopsy Set. This set enables the reliable analysis of cfDNA from urine using molecular testing technologies such as qPCR, digital PCR, and next-generation sequencing (NGS). The PAXgene Urine Liquid Biopsy Set tackles the challenge of accessing cfDNA in urine by integrating a preservation solution that stabilizes cfDNA at the point of collection. It is the first set to offer a validated, standardized, and comprehensive preanalytical workflow, making urine cfDNA analysis more accessible for research purposes.

Image: The PAXgene Urine Liquid Biopsy Set is the first standardized preanalytical workflow that stabilizes cell-free DNA in urine for subsequent analysis (Photo courtesy of PreAnalytiX)

The PAXgene Urine Liquid Biopsy Set marks a significant improvement in sample quality, standardization, and ease of use for researchers handling urine samples. It features a closed system for urine collection and cfDNA stabilization, offering flexibility for sample shipment and storage under various conditions. Additionally, it integrates seamlessly into established workflows and is compatible with QIAGEN's industry-leading sample preparation products. Developed in line with Europe’s latest CEN/TS standards for the preanalytical handling of urine cfDNA, the set provides an optimized and standardized workflow.

Urine liquid biopsy has immense potential to aid researchers in detecting minimal residual disease, monitoring treatment responses, and identifying therapeutic targets, complementing blood plasma analysis for a more comprehensive understanding. However, unlike blood samples, there has been a lack of well-established technical solutions for the collection, storage, transport, and processing of urine samples—until now. The PAXgene Urine Liquid Biopsy Set bridges this gap. Commercialized by QIAGEN, the new set complements the company’s broader portfolio of liquid biopsy solutions, which cover various analytes (circulating cell-free nucleic acids, tumor cells, exosomes) and molecular detection technologies (NGS, qPCR, digital PCR), empowering researchers and clinicians to harness the full potential of liquid biopsy across diverse applications.

“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,” said Dr. Uwe Oelmueller, PreAnalytiX Management Committee Co-Chair and Head of MDx Development Sample Technologies at QIAGEN. “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."

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PreAnalytiX GmbH
QIAGEN N.V.
BD