Clinical Genomics launches Colvera

BRIDGEWATER, N.J.—Ten years after research, development and clinical validation in more than 4,000 patients, biotech Clinical Genomics believes it has found the key to detecting the recurrence of colorectal cancer. The new secret weapon is Colvera, a blood-based test for colorectal cancer (CRC) recurrence monitoring.

The Colvera test will be performed in Clinical Genomics’ dedicated CLIA-registered laboratory in Bridgewater, while Quest Diagnostics provides 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,” states Lawrence LaPointe, 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.”

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, which is 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, according to the company. Another plus is that Colvera does not require specialized equipment or modifications to clinical protocol.

“Although CEA has been used for more than three decades to monitor patients for cancer relapse and spread,” LaPointe tells DDNews, “the test may yield false positive results that can be caused by lifestyle factors (e.g., smoking) and other non-cancer conditions.”

“Recurrence monitoring following an initial diagnosis and treatment of CRC is different from screening, which typically refers to tests that look for initial indications of disease,” he says. “There are several available types of screening tests, including fecal immunochemical tests (FIT), optical colonoscopy and stool-based tests that assess specific genetic changes associated with cancer. The rate of CRC recurrence following surgical resection with curative intent is high (30 to 50 percent), with the majority of recurrences happening within two to three years of initial treatment.”

Five-year survival rates are extremely high if detected early, but vary considerably depending on the stage at diagnosis, LaPointe says.

Clinical Genomics continues to evaluate Colvera in clinical studies and focuses on expanding availability of Colvera.

Clinical Genomics last year brought in $15 million in a Series A round to support development of its genetic test for colorectal cancer, with Sydney, Australia-based venture capital firm OneVentures leading the round. Clinical Genomics used the funds to ramp up marketing for its two-gene blood test for post-surgical monitoring of CRC recurrence.

With a broad intellectual property portfolio consisting of more than 20 patents, Clinical Genomics—via its wholly owned subsidiary Enterix Inc.—also currently offers the user-friendly, patient-preferred CRC screening InSure FIT assay. InSure is also marketed as a lab-based test in Australia and other countries.