Qiagen and Clinical Genomics, a private company developing evidence-based diagnostic tools for colorectal cancer, have implemented the PAXgene Blood ccfDNA Tube sample collection in Clinical Genomics’ Colvera colorectal cancer (CRC) recurrence assay. 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.

“The Colvera test represents a unique opportunity for convenient, non-invasive monitoring of colorectal cancer patients by detecting methylated circulating tumor DNA that may indicate recurrence of a cancer. We are pleased to collaborate with Clinical Genomics in expanding the range of benefits made possible through liquid biopsies, which hold great promise for improving the lives of patients in cancer and other fields of medicine,” said Thierry Bernard, Senior Vice President and Head of Qiagen’s Molecular Diagnostics Business Area.

“We are extremely pleased to use the highly automated QIAsymphony PAXgene Blood ccfDNA collection and sample processing workflow for collection and handling of Colvera samples. As a long-term commercial and research partner of Qiagen, we have a great deal of confidence in this new solution," said Dr. Lawrence LaPointe, CEO of Clinical Genomics. “We are excited to roll out the PAXgene System as the front-end solution to allow physicians to provide Colvera testing to CRC patients as conveniently as possible. PAXgene allows a simple blood collection at the physician’s office, with no on-site processing required, which is a great step forward from our alternative sample collection methods.”

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”).

Clinical Genomics is the sole U.S. provider of Colvera, a PCR-based assay that detects hypermethylated BCAT1 and 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. PAXgene 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. 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. In 2015, Qiagen introduced the first regulated companion diagnostic assay based on molecular biomarkers from circulating tumor DNA. Qiagen has created a wide range of strong standards for the processing of liquid biopsy samples, including circulating cell free DNA, messenger RNA, circulating tumor cells, exosomes and others. Many of the solutions offer fully integrated and highly automated workflows spanning from collection through to the purified nucleic acid. The Qiagen solutions are used in numerous diagnostic and research workflows and represent gold standards in terms of performance. Such solutions allow liquid biopsies to be easier and less expensive to perform than tissue biopsies. And they allow for significantly improved sensitivity, specificity and robustness of liquid biopsies which can be reliably repeated at regular intervals for monitoring of disease progression.