Privately-held biotech company, Clinical Genomics, has developed and launched a two-gene blood test for colorectal cancer recurrence monitoring that is capable of detecting twice the number of recurrence cases than the available traditional guideline-recommended test. 

Colorectal cancer is the second leading cause of cancer-related deaths in the U.S., with 51,813 Americans dying from the disease in 2013, according to the Centers for Disease Control and Prevention. More than 600,000 people die from colorectal cancer each year world-wide. While early detection can lead to positive outcomes, only about four out of 10 cases are detected early. 

Recurrence occurs in 30 to 50 percent of all cases among individuals that undergo surgical treatment.

CEO and co-founder Lawrence LaPointe, Ph.D., spoke to Bioscience Technology about the company’s latest offering and how it can provide a clinical benefit.

Formed in 2006, Clinical Genomics was spun-out from another company co-founded by LaPointe, Enterix Inc.  Enterix was formed to look at introducing next-generation screening technologies for colorectal cancer, and was sold to Quest Diagnostics in 2006 for an enterprise value of more than $50 million. LaPointe, who is also a published research scientist and holds patents in the fields of biomarker discovery, cancer detection and molecular diagnostics, thinks that the liquid biopsy space is one that is very exciting and holds a lot of promise.

The test, called Colvera, detects circulating tumor DNA (ctDNA) from plasma samples and measures methylated changes in either or both of the two genes BCAT1 and IKZF1.   If gene methylation, which is a chemical alteration associated with tumor growth and invasion, is detected in either of the genes, then patients are recommended to be treated for suspicion of colorectal cancer replase, usually with a CT scan, LaPointe explained.

The current standard of care for colorectal cancer recurrence monitoring is carcinoembryonic antigen (CEA) testing, which measures a protein and has been around since the mid-70s. 

CEA has some drawbacks and LaPointe said that it is sometimes described as a “better than nothing test.” He noted that there are some questions to what is behind changes in the amount of protein in the blood, because while it could be due to cancer recurrence, it could also be attributed to changes in smoking habits or other inflammation in the body.

“The specificity of CEA is something that’s a well-known deficiency,” LaPointe said. “There are well understood deficiencies in sensitivity as well.”

LaPointe doesn’t think CEA testing should be abandoned, but rather sees it as a positive that physicians don’t have to make an “either or” decision.  A doctor ordering a CEA test for colorectal cancer monitoring is already drawing a tube of blood, so that same blood sample can be used to measure Colvera specimen.

“We can in fact be entirely complimentary,” LaPointe said.

The clinical validity of the test was documented in more than 3,400 patients and reported in four peer-reviewed journal articles that were published in 2015.

A study, published Oct. 11, 2016, in Cancer Medicine, showed that the two-gene blood test positively detected twice the number of colorectal cancer recurrence cases as CEA testing.

LaPointe also presented data supporting the clinical utility of the test in January at the American Society of Clinical Oncology 2017 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.

For the year ahead, Clinical Genomics will focus on building awareness around its two-gene test and working with key opinion leaders and advocates in the space to help them understand the utility of the test.

Based on the available data and the validation work that was carried out, the company believes there is real value of running the test as an adjunct to CEA for colorectal cancer monitoring today, LaPointe said.

Clinical Genomics has offices and CLIA-registered laboratories in Bridgewater along with FDA-registered and TGA-licensed IVD manufacturing in Edison, New Jersey and Sydney, Australia and a NATA-accredited laboratory in North Ryde, NSW Australia.

Contributing Editor/Science Writer