PreAnalytiX, a joint venture (JV) between QIAGEN and BD (Becton, Dickinson and Company), has launched the PAXgene Urine Liquid Biopsy Set (PAXgene).

The biopsy set is designed to enable a reliable analysis of cell-free DNA (cfDNA) from urine using a collection cup and a nucleic acid stabilising tube.

It uses various molecular testing methods like qPCR, digital PCR, and next-generation sequencing (NGS).

QIAGEN plans to commercialise the PAXgene Urine Liquid Biopsy Set shortly.

PAXgene is intended to tackle the challenge of accessing cfDNA from urine by using an integrated preservation solution.

According to QIAGEN, the easy-to-use biopsy set for non-invasive urine collection and cfDNA stabilisation offers a verified and standardised preanalytical workflow. This makes urine cfDNA more accessible for research analysis and clinical use.  

PreAnalytiX management committee co-chair and QIAGEN’s MDx development sample technologies head 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.”

QIAGEN, which is based in the Netherlands, said that the PAXgene Urine Liquid Biopsy Set advances sample quality, standardisation, and ease of use for researchers.  This closed configuration set is said to offer flexible options for sample shipment and storage.

In addition, it integrates into existing workflows and is compatible with QIAGEN’s gold-standard sample preparation products.

The new set expands QIAGEN’s other liquid biopsy solutions, covering all analytes, including circulating cell-free nucleic acids, tumour cells, and exosomes.

It supports various molecular detection technologies, such as NGS, qPCR, and digital PCR. This empowers researchers and clinicians to use liquid biopsy in diverse applications.

PreAnalytiX was established in 1999 by QIAGEN and BD. The JV aims to develop, manufacture, and market integrated systems for the collection, stabilisation, and purification of nucleic acids (DNA and RNA) used in molecular diagnostic testing.