Knoxville residents can try a new blood test to screen for cancer before a colonoscopy

A Knoxville company has launched a blood test locally that could reshape how patients get one of the more unpleasant but essential medical tests: screening for colorectal cancer.

The test, called ColoHealth, is for patients who are unwilling or unable to undergo a colonoscopy or stool test. ColoHealth is the next generation of the first and only FDA-approved blood test for colorectal cancer screening, Epi proColon, and it looks for altered DNA associated with the cancer.

New Day Diagnostics, formerly EDP Biotech, launched the test guided by the philosophy that cancer screenings should be accessible, affordable and empowering for patients. The company also believes that the best colorectal screening method is the one a patient will agree to.

The test is now available to Knoxville residents or those who travel to Knoxville, but it could soon be available nationwide. It's less expensive than the other blood test on the market and could be covered by insurance if there's a medical necessity.

The U.S. Preventive Services Task Force recommends all Americans over the age of 45 get a colonoscopy every 10 years, but around 30% of eligible U.S. adults have never been screened for colorectal cancer.

That's a major roadblock to reducing colorectal cancer cases and death. In 2023, there were approximately 150,000 new cases and over 50,000 deaths from colorectal cancer in the U.S. In Tennessee, three people die every day from colorectal cancer. It is also becoming more common in young adults.

"There are certain communities and subgroups in the East Tennessee area that have even higher instances of colorectal cancers, so we know that this is really important," Eric Mayer, CEO and president of New Day Diagnostics, told Knox News. "We understand that this is a need in our community specifically."

For now, New Day is testing all ColoHealth blood samples at its lab in Knoxville. Mayer said he expects the FDA to transfer approval to the test's new name this summer after the lab gathers more data.

"Eventually, it will be ready at doctors' offices around the country. For our initial launch this month, we are requesting everyone come here to our home base in Knoxville," Mayer said.

Like other non-invasive colorectal cancer screenings, ColoHealth is not intended to replace a colonoscopy, but to guide the right patients toward the procedure if they need it.

Here's what to know about the test, including how it compares to another blood test for colorectal cancer screening that got wide media attention earlier this year but has not been approved by the FDA.

How to get a colorectal cancer blood test in Knoxville

Getting a ColoHealth blood test begins with talking to your doctor, Mayer said. If a health care provider thinks it's a good test for you, getting screened is a three-step process:

• Answer pre-screening questions online that get reviewed by a physician at New Day

• Schedule blood draw at New Day's Knoxville lab

• Wait for results

Results from the test take 7-10 business days, though the lab is working to reduce that to 2-3 business days as the test becomes more widely available, Mayer said.

ColoHealth is also affordable at $199. For comparison, the Cologuard stool sample kit costs around $500 and the average colonoscopy in the U.S. is $2,750, though insurance often covers screening for adults over 45.

"It's accurate, it's affordable, it's convenient, it's easy to take," Mayer said. "You don't have to skip two or three days of work and eventually this will be available as part of an annual wellness exam."

How accurate is colorectal cancer blood test?

As a first step, ColoHealth is much easier than a colonoscopy, which requires a liquids-only diet followed by medication and an invasive procedure.

Just because ColoHealth helps patients who don't want a colonoscopy, the procedure can't be avoided for patients at high risk. The next step after a positive blood test result is a colonoscopy.

"If you get a positive result, you need that colonoscopy," said Jason Liggett, chief scientific officer at New Day Diagnostics. "We're not advocating for people skipping their 10-year colonoscopy. Our goal is to drive the right people to colonoscopy and to increase colonoscopy compliance."

How accurate is the test? About 60% of people with a positive ColoHealth result will have "actionable findings" in a follow-up colonoscopy, said Jessica Etheridge, New Day's director of marketing and branding. But any positive ColoHealth test is a sign of an "abnormal finding" associated with colorectal cancer, Etheridge said.

Colonoscopies remain the gold standard of colorectal cancer screening because they allow a doctor to see inside the large intestine and remove pre-cancerous growths called polyps.

ColoHealth has advantages over Guardant test

Another blood test for colorectal cancer screening has shown early promise in the lab and caused a stir in the national media. The test, called Shield, is a product of Guardant Health in Silicon Valley.

Shield has not yet been approved by the FDA and is not covered by insurance. It currently costs $895 out of pocket. That's compared to $199 for ColoHeath.

Another advantage of ColoHealth is its origins. Rather than a completely new test, it's a rebranding and improvement of the first FDA-approved blood test for colorectal cancer screening, Epi proColon. The test was approved in 2016 under its former company, Epigenomics in Germany.

New Day Diagnostics prepares to grow in new space

New Day Diagnostics acquired the assets of Epigenomics and is preparing to double its lab size. It will be an anchor tenant of a new building under construction at the University of Tennessee at Knoxville Research Park at Cherokee Farm.

It's already grown after a merger last year between New Day Diagnostics and EDP Biotech. The new lab space will mean more jobs, more cancer screening technology and a bigger bioscience presence in Knoxville.

EDP Biotech, founded in 2005, initially focused on high-risk polyps in stage 1 and 2 colorectal cancers, Mayer said. As New Day Diagnostics, the company is also working on ColoPlex Plus, a next generation early detection test to find pre-cancerous polyps.

In the new space, the company will incorporate automation to process tests faster and expand to other forms of cancer. The COVID pandemic showed the public how crucial diagnostic work is, and New Day Diagnostics is taking that momentum to stay at the cutting edge of national science from Knoxville.

"Our investors are local individuals," Mayer said. "This is not venture capital money from Silicon Valley, this is friends and family down the road putting their life savings to work over many years."

Daniel Dassow is a growth and development reporter focused on technology and energy. Phone 423-637-0878. Email daniel.dassow@knoxnews.com.

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This article originally appeared on Knoxville News Sentinel: Knoxville lab launches colohealth blood test for colorectal cancer