Clinical Genomics introduces new blood-based test for CRC recurrence monitoring

Dec 22 2016

Centralized CLIA-registered laboratory commences operations

Clinical Genomics, a private company developing evidence-based diagnostic tools for colorectal cancer, today announced the launch of Colvera™, a blood-based test for colorectal cancer (CRC) recurrence monitoring. Colvera is the result of a decade of research, development and clinical validation in more than 4,000 patients. Colvera will be performed in Clinical Genomics' dedicated CLIA-registered laboratory in Bridgewater, NJ.  

Quest Diagnostics, the world's leading provider of diagnostic information services, will provide specimen collection and logistics services for Colvera test orders. Terms of the agreement were not disclosed.

"Colorectal cancer outcomes improve with early detection, but many recurrence monitoring tests fail to detect disease at a point when clinical intervention has the best chance to be effective," said Lawrence LaPointe, Ph.D., President and CEO of Clinical Genomics. "Colvera is a new test that can aid in the identification of molecular changes associated with cancer development. Colvera is intended to provide physicians with actionable information that can trigger further clinical assessment, which may lead to improved outcomes."

Colvera is a qualitative test that indicates the presence or absence of two altered genes associated with CRC. Colvera measures methylation – a genetic change associated with cancer development – in circulating tumor DNA (ctDNA), the fragments of genetic material that leak from a tumor into the bloodstream. Unlike DNA mutations, which are frequent in cancer but may vary widely between patients and may undergo mutation shifts during the course of disease, methylation is a more stable feature in tumors that is readily measured. Colvera is not intended to stratify the risk of recurrence in colorectal cancer patients, but rather to identify the presence of disease at the time of testing.

In a study recently published in the peer-reviewed journal Cancer Medicine, clinical data showed that Colvera detected twice the number of recurrence cases as carcinoembryonic antigen (CEA) testing, the standard blood test used for CRC recurrence monitoring. As Colvera only requires a peripheral blood sample, the test can be administered along with other CRC surveillance tests, including CEA. Colvera does not require specialized equipment or modifications to clinical protocol.

"This is a welcome development in the field of colorectal cancer recurrence monitoring," noted Peter Mencel, M.D., a medical oncologist with Atlantic Hematology Oncology, in Manasquan, New Jersey. "Our goal is to help our patients by detecting a recurrence at the earliest possible time, when the opportunity to undertake curative surgery is greatest. I am hopeful that Colvera will provide clinicians with a new and more informative tool to guide management of our patients."

Clinical Genomics is actively pursuing several research-based collaborations with leading academic and private cancer centers to continue to expand the clinical applications of Colvera.