Convenient Blood Test Detects Circulating DNA to Identify Recurrence of Tumors

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QIAGEN and colorectal cancer diagnostics company Clinical Genomics, tell us they have implemented the PAXgene® Blood ccfDNA Tube* sample collection in Clinical Genomics’ Colvera™ colorectal cancer (“CRC”) recurrence assay.

Clinical Genomics’ Colvera, an integrated liquid biopsy solution, is designed to enable easy and accurate monitoring for recurrence of colorectal cancer with a simple blood test collected in a physician’s office. Clinical Genomics is the sole U.S. provider of Colvera, a PCR-based assay that detects hypermethylated BCAT1and IKZF1 DNA in the blood of patients. Colvera has been demonstrated to detect more than twice the number of CRC recurrence cases compared to the current guidelines-recommended blood test.

Colvera samples in the U.S. will be transported to Clinical Genomics’ laboratory in Bridgewater, New Jersey.

QIAGEN is a global leader in developing Sample to Insight workflows for non-invasive liquid biopsies in oncology, prenatal testing and other applications. QIAGEN solutions for liquid biopsy sample processing are widely used by pharmaceutical and biotech companies to develop screening tests, diagnostics and companion diagnostics using liquid biopsies and PCR or NGS analysis of biomarkers for stratification or monitoring of patients.

The PAXgene Blood ccfDNA System was developed by PreAnalytiX GmbH, a QIAGEN / BD joint venture company. The technology offers highly integrated and automated solutions for the collection, stabilization and purification of circulating cell-free DNA from blood samples. It allows whole blood to be drawn and stored at cooled and ambient temperatures for up to seven days before samples are processed and tested for the presence of circulating cell-free DNA.

In collaboration, Clinical Genomics and QIAGEN have demonstrated that PAXgene ccfDNA yield and Colvera assay performance is equivalent to the performance from blood samples collected in EDTA tubes, spun down to plasma and frozen within eight hours of collection – whereby the PAXgene process demonstrated a significantly superior ease of use and robustness.

These findings will be presented in a poster at the Association for Molecular Pathology (“AMP”) Annual Meeting to be held in November in Salt Lake City, Utah (Murray D et al, “Effect of blood collection tubes on circulating tumor DNA (ctDNA) yield and specificity”).

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