Keeping it simple

BRIDGEWATER, N.J. – Targeted toward an early diagnosis of the recurrence of colorectal cancer, privately held biotech Clinical Genomics has implemented technical partner QIAGEN’s 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 doctor’s office.

“The PAXgene system will enable physicians to provide Colvera testing to CRC patients as conveniently as possible, with no on-site processing required—a great step forward from our alternative sample collection methods,” says Dr. Lawrence LaPointe, 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.”

If this novel technology continues to prove successful, discovering the recurrence of colorectal cancer could be life-saving for thousands of patients, already diagnosed at least once with one of the most fatal cancers.

LaPointe tells DDNews: “Clinical Genomics has made running Colvera dramatically simpler for our customers (oncologists and surgeons). They can now draw a blood sample from a patient that is being monitored for colorectal cancer recurrence, and that specific specimen can be transported at room temperature for up to a week to reach the lab.”

Colvera is indicated “only for patients that have been previously treated for colorectal cancer and who have no evidence of current disease,” LaPointe adds. “These patients undergo testing to identify the recurrence as early as possible to improve the treatment options.”

“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,” states 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.”

Furthermore, the Clinical Genomics/QIAGEN partnership has reportedly demonstrated that PAXgene ccfDNA yield and Colvera assay performance are 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.

The PAXgene technology stabilizes and purifies circulating cell-free DNA from blood samples, allowing 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 2015, QIAGEN introduced the first regulated companion diagnostic assay based on molecular biomarkers from circulating tumor DNA, and created standards for the processing of liquid biopsy samples, including circulating cell free DNA, messenger RNA, circulating tumor cells, exosomes and others.

In 2016, Clinical Genomics launched Colvera. A study published in the peer-reviewed journal Cancer Medicine showed that Colvera detected twice the number of recurrence cases as carcinoembryonic antigen testing, the current guidelines-recommended blood test used for CRC recurrence monitoring. Preliminary data from this study were presented to the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium (ASCO GI).

“Given that at least 30 percent of patients in remission from CRC following initial treatment will develop recurrence, improved surveillance methods that accurately detect recurrence are essential for improving outcomes for patients," says contributing study author Dr. Graeme P. Young, Matthew Flinders Distinguished Professor at the Flinders University Centre for Innovation in Cancer in Adelaide Australia.

“Data from this study reinforce previous findings that ctDNA can be reliably detected in CRC patients,” Young says. “Furthermore, the results suggest that when used in ongoing surveillance of cases in remission, a positive BCAT1/IKZF1 test has the potential to establish a new approach for earlier detection of recurrent CRC by detecting more unsuspected recurrences and triggering earlier imaging studies. Additional prospective studies of the methylated BCAT1/IKZF1 test compared with CEA are ongoing."