PreAnalytiX Launches Innovative Urine-Based Liquid Biopsy Solution with PAXgene® Urine Kit

PreAnalytiX GmbH, a joint venture between QIAGEN and BD, announced the launch of the PAXgene® Urine Liquid Biopsy Kit, an innovative product that enables reliable analysis of cell-free DNA (cfDNA) in urine through molecular testing technologies such as qPCR, digital PCR, and next-generation sequencing (NGS). QIAGEN will be responsible for the global commercialization of the kit.

PAXgene Urine Liquid Biopsy Kit addresses the challenge of obtaining cfDNA from urine through an integrated preservation solution. The product features a convenient urine collection device and a cfDNA stabilization mechanism, while also introducing, for the first time, a standardized pre-analytical workflow, significantly enhancing the research and clinical application potential of urine cfDNA.

Urinary cfDNA Provides Important Opportunities for Future Research and Clinical Applications. It can not only help detect genetic modifications and mutations, analyze methylation status, but also provide genomic information that is difficult to obtain from blood samples. However, cfDNA in urine samples degrades rapidly after collection and may produce misleading genomic DNA, posing numerous challenges for analysis.

"Cell-free DNA isolated from urine is a truly non-invasive liquid biopsy approach, but proper sample handling is crucial. The standardized workflow of the PAXgene Urine Liquid Biopsy device offers convenience for urine sample collection and is compatible with various downstream analytical techniques, including hotspot analysis, gene panel analysis, and whole-genome analysis. These techniques provide important complements to blood-based analyses," said Professor Ellen Heitzer from the Medical University of Graz, Austria.

Uwe Oelmueller, Ph.D., Co-Chair of the PreAnalytiX Management Board and Head of MDx Development Sample Technologies at QIAGEN, added: "We are pleased to meet the market demand for devices that stabilize, transport, and store urine samples with the PAXgene Urine Liquid Biopsy Kit. The potential of liquid biopsies is immense, but accurate test results heavily rely on stringent pre-analytical workflows. This kit ensures sample stability post-collection, enhancing the reliability and reproducibility of test results."

This innovative device has significantly enhanced urine liquid biopsy research by not only simplifying the collection and stabilization of cfDNA but also providing multiple options for sample transport and storage. The kit can be seamlessly integrated into existing workflows and is compatible with QIAGEN's gold-standard sample preparation products, ensuring compliance with the latest CEN/TS standards in Europe, offering an optimized solution for the standardized pre-processing of urine samples.

Urine liquid biopsy has broad application prospects, helping researchers detect minimal residual disease, monitor treatment response, and identify therapeutic targets. Compared with blood samples, the collection and processing of urine samples still lack mature technical solutions, and the PAXgene Urine Liquid Biopsy Kit fills this critical gap.

This product will complement QIAGEN's existing liquid biopsy solutions, covering various analytes such as circulating cell-free nucleic acids, tumor cells, and exosomes, and support mainstream molecular detection technologies including qPCR, digital PCR, and NGS, further enhancing the application capabilities of researchers and clinicians in the field of liquid biopsy.

About PreAnalytiX GmbH:

PreAnalytiX GmbH, founded jointly by QIAGEN and BD in 1999, is dedicated to the development, production, and sale of integrated systems for the collection, stabilization, and purification of nucleic acids (DNA and RNA) used in molecular diagnostics.