PreAnalytiX has introduced the PAXgene urine liquid biopsy set, which enables cell-free DNA (cfDNA) analysis from urine with molecular testing technologies.

The company is a joint venture between Qiagen and BD.

The biopsy set is designed to overcome the challenges associated with cfDNA degradation, offering a verified, standardised preanalytical workflow.

Urine cfDNA is increasingly recognised for its potential in research and future clinical applications. It provides a non-invasive means to detect genetic modifications and generate genomic data not found in blood samples.

The rapid degradation of cfDNA in urine samples has posed significant challenges for accurate analysis. The PAXgene urine liquid biopsy set is poised to change this, providing a method for urine collection and cfDNA stabilisation.

Qiagen MDx Development Sample Technologies head and PreAnalytiX Management Committee co-chair Dr Uwe Oelmueller said: “With the innovative PAXgene urine liquid biopsy set, we are excited to address a pressing market need for a urine collection, stabilisation, transport and storage device that is integrated into a complete preanalytical workflow for the development of cfDNA-based tests.”

The product is compatible with a range of molecular testing technologies, such as qPCR, digital PCR, and next-generation sequencing (NGS), and will be commercialised by Qiagen.

The PAXgene urine liquid biopsy set offers a closed configuration for urine collection and stabilisation of cfDNA, supporting various sample shipment and storage conditions.

It aligns with Europe's latest CEN/TS standard for preanalytical urine handling for isolated cell-free DNA.

This launch complements Qiagen's portfolio of liquid biopsy solutions, which cover a broad spectrum of analytes and molecular detection technologies.

In March 2023, Qiagen collaborated with Servier to develop a companion diagnostic test for the IDH1 inhibitor, Tibsovo, which is indicated for the treatment of the blood cancer acute myeloid leukaemia.