Clinical Genomics launches blood test for monitoring colorectal cancer recurrence

Clinical Genomics has launched a blood-based test for monitoring colorectal cancer recurrence called Colvera, the company announced.

This is a circulating tumor DNA (ctDNA) test for colorectal cancer that can detect methylated DNA from the BCAT1 and IKZF1 genes.

The results of a recent study performed by Graeme Young, PhD, the Matthew Flinders Distinguished Professor at Flinders University Center for Innovation in Cancer, in Australia, and colleagues — which were published in Cancer Medicine showed Colvera detected twice as many cases of post-surgical CRC recurrence than the standard blood test used for CRC recurrence monitoring, the carcinoembryonic antigen (CEA) test. Among 122 patients evaluated, 28 had recurrent CRC, which Colvera detected 68% of the time and CEA detected 32% of the time (P = .002).

“Current professional guidelines recommend inclusion of the combination of the simple test CEA ... with regularly scheduled CT scans for detection of recurrence in colorectal cancer patients who have been treated for stage II or III and in whom remission has been induced,” Young told Healio Gastroenterology. “CEA has not been proved to be as effective as we would like and is subject to false-positive results related to non-cancer events such as smoking. Colvera is a new test that can indicate early molecular changes associated with cancer. Our study has shown that Colvera is significantly more sensitive than CEA.”

Quest Diagnostics will collect specimens and provide logistics services for test orders, the terms of which were not disclosed, and Clinical Genomics’ CLIA-registered lab will perform the Colvera tests, according to the press release. The test only requires a peripheral blood sample, so it can be administered with other CRC surveillance tests, including CEA, and it does not require specialized equipment or changes to clinical protocols.

Colvera is intended to detect the presence of CRC recurrence at the time of testing, and is not intended to stratify the risk for recurrence, according to the press release.

“By providing clinicians with a better simple blood test we anticipate that Colvera will increase the likelihood of detecting curable recurrences of CRC, with the ultimate aim of saving lives,” Young said.

The company intends to study the test further in collaboration with academic and private cancer centers to expand its clinical applications. – by Adam Leitenberger


Young GP, et al. Cancer Med. 2016;10.1002/cam4.868.

Disclosures: Young reports he is a consultant for Clinical Genomics.