Qiagen, Hilden, Germany, and Clinical Genomics, Bridgewater, NJ, have implemented the PaxGene Blood ccfDNA tube sample collection in Clinical Genomics’ Colvera colorectal cancer recurrence assay. An integrated liquid biopsy solution, the Colvera assay is designed to enable easy and accurate monitoring for recurrence of colorectal cancer with a simple blood test collected in a physician’s office.

Photo Bernard Thierry

Thierry Bernard, Qiagen.

“The Colvera test represents a unique opportunity for convenient, noninvasive monitoring of colorectal cancer patients by detecting methylated circulating tumor DNA that may indicate recurrence of a cancer,” says Thierry Bernard, senior vice president and head of Qiagen’s molecular diagnostics business area. “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.”

“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,” says Lawrence LaPointe, PhD, CEO of Clinical Genomics. “As a long-term commercial and research partner of Qiagen, we have a great deal of confidence in this new solution. We are excited to roll out the PaxGene system as the front-end solution to allow physicians to provide Colvera testing to colorectal cancer patients as conveniently as possible. PaxGene allows a simple blood collection at the physician’s office, with no onsite 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 ethylenediaminetetraacetic acid tubes, spun down to plasma, and frozen within 8 hours of collection. These findings will be presented in a poster session at the Association for Molecular Pathology annual meeting to be held in November in Salt Lake City.

Clinical Genomics is the sole US provider of Colvera, a polymerase chain reaction-based assay that detects hypermethylated BCAT1 and IKZF1 DNA in the blood of patients. PaxGene technology offers 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 7 days before samples are processed and tested for the presence of circulating cell-free DNA. Colvera samples in the United States will be transported to Clinical Genomics’ laboratory in Bridgewater, NJ.

For more information, visit Clinical Genomics and Qiagen.