Clinical Genomics' new blood test does the same thing as a 1970s test, only better.

Amanda Pedersen

If old dogs can indeed be taught new tricks, perhaps the same is true for blood tests. That appears to be the case with a new blood-based test for colorectal cancer (CRC) recurrence monitoring developed by Clinical Genomics.

While the test does fall under the rather broad, and arguably vague, umbrella of liquid biopsy, CEO Larry LaPointe prefers to use more specific terms, calling it a circulating tumor DNA (ctDNA) assay.

Categorization aside, one thing that makes Clinical Genomics' Colvera test interesting is the fact that it actually is intended to augment a classic biomarker, carcinoembryonic antigen (CEA), that has been around since the 1970s, LaPointe told Qmed. CEA is the type of test that is great when it works, he said, but has some fairly well-recognized deficiencies.

Colvera is essentially providing the same information as the CEA test, LaPointe said. "But it's providing it in a better way and it's more informative," he added. "That's the key."

Colvera is being marketed as a qualitative test that indicates the presence or absence of two altered genes associated with CRC, BCAT1 and IKZF1. It does this, LaPointe explained, by measuring methylation, a genetic change associated with cancer development, in ctDNA, which are fragments of genetic material that leak from a tumor into the bloodstream.

It's not meant to measure chemotherapy response or to provide information about the phenotype of the disease, and it's not intended to be a risk score test that predicts a patient's chance of having recurrence in the future.

"We're simply saying 'there's circulating tumor DNA in the blood today, and that's probably not a good thing," LaPointe said.

And the company proved that point in a study recently published in the peer-reviewed journal Cancer Medicine, that showed Colvera detected twice the number of recurrence cases as CEA testing. But it doesn't have to replace CEA, it can be administered alongside it, or other CRC surveillance tests, the Bridgewater, N.J.-based company noted.

Quest Diagnostics will provide specimen collection and logistics services for Colvera test orders. Financial terms of that agreement were not disclosed.

"When we look at the genomics space, and in particular the liquid biopsy space, there's a lot of work going on, and in many ways Colvera is the simple example of how that [work] can make a difference and really have impact," LaPointe said.

The company is focused on CRC recurrence, he said, because up to 50% of patients treated for CRC will have a recurrence. "It's just one of these diseases where there's such clear and compelling need to introduce innovation that actually has impact," LaPointe said. "That's really what Clinical Genomics is focused on. It's not innovation for innovation's sake, it's innovation where we can have impact and where there's a need and we can do some good."

Likewise, LaPointe said the company is specifically focused on recurrence monitoring for colorectal cancer, not on screening, because the market is already full of companies designing cancer screening liquid biopsy tests.

"There is a lot of focus on screening, and there needs to be," LaPointe said. "But what's intriguing to me, particularly as someone who has been involved with screening for so long, is what happens to patients once they've done a screening test, discovered they have cancer, go through treatment, and become part of that monitoring and surveillance process that the whole screening world doesn't address very well?"

It was in looking at that opportunity, LaPointe said, that Clinical Genomics decided recurrence testing was an area with a bigger unmet need. The mortality rate associated with colorectal cancer in particular has more to do with metastasis than a tumor in the bowel, he said.

Amanda Pedersen is Qmed's news editor. Reach her at [email protected].

[Image credit: Pixabay.]