Doctors say new FDA approval of colon cancer-detecting blood test could increase screenings

NEW ORLEANS (WVUE) - According to New Orleans gastrointestinal doctors, a new FDA-approved blood test for detecting colon cancer could be an answer to a growing problem in the United States.

They believe convenience could lead to increased screenings.

Colorectal cancer is the second-deadliest cancer in the US. But doctors say it’s sometimes preventable and often treatable if detected early through proper screening.

The American Cancer Society estimates that more than 150,000 people will be diagnosed with a type of colorectal cancer in 2024 and that it will cause more than 53,000 deaths.

Jess Palazzolo lost her brother to colon cancer. At first, his pain and symptoms were thought to be from a work-related injury. By the time he was diagnosed, it was too late.

“It’s a serious, serious thing,” said Palazzolo. “I miss him dearly.”

Dr. Jonathan Mizrahi said many eligible adults avoid the screening process altogether, and that’s where the FDA approval for using the “Shield” test as a primary screening option can really make a difference.

It’s the first prescription blood test approved by the FDA as a primary screening option for colorectal cancer.

“This is a very good day,” said Mizrahi, a gastrointestinal medical oncologist with Ochsner MD Anderson Cancer Center. “It is another non-invasive tool to close that gap between the folks that we want screened and the folks that actually are getting screened.”

Dr. Brobson Lutz of the Orleans Medical Society said, “A lot of people don’t like dealing with sending in stool specimens, and colonoscopy takes a day out of your life, literally.”

The new test arrives just a few years after the US Preventative Services Task Force lowered the suggested screening age.

“We are seeing a troubling and increasing trend of younger and younger patients getting diagnosed with colorectal cancer, for mostly reasons we don’t completely understand,” Mizrahi said. “But (we see) even patients in their 40s, 30s, sometimes even in their 20s.”

The liquid biopsy, which detects tumor DNA in blood samples, is for adults 45 and older at an average risk for colon cancer.

Recent studies suggest it’s more than 80% effective at detecting stages one, two and three colorectal cancers.

“You could get drawn with your other routine blood work you might do when you go to the doctor,” Mizrahi said.

A clinical trial found that the Shield tests’ false-positive rate is about 10 percent, and it only detected 13 percent of large polyps. When detected, pre-cancerous lesions can be removed before developing into a tumor.

Lutz said the technology is very good, but so is the marketing.

“I suspect the PR on these is better than the medical advance, if you want to know the truth,” Lutz said.

Lutz said he’s happy with the existing stool-screening tests and said Shield is not a replacement for colonoscopies, which are recommended every 10 years starting at age 45.

“The colonoscopy will remain the gold standard for colon screening,” Lutz said. “I certainly hope that technology involving these liquid biopsies evolves into something useful. ... I’m all for newer technology when it’s cost-effective and accurate and gives good results.”

Mizrahi said it comes down to each individual patient.

“I think we all in the field of medicine need to be very comfortable moving with the field,” Mizrahi said.

He said using the blood test to detect cancer is definitely an expanding field.

“I absolutely do think this blood-based way of testing can be the way of the future, as we refine kind of what exactly we need to be looking for, and making sure the rates of false negatives and false positives are really acceptable to us,” Mizrahi said.

Palazzolo said she is just thrilled progress is being made.

“I think that’s great,” she said. “Early detection is, I think, the key, especially with colon cancer. ... So, yeah, let’s go for it. I do hope that a lot of colon cancer can be detected early and taken care of before it gets to the point of no return.”

The Shield test meets the requirements for Medicare reimbursement. It’s already commercially available, but the FDA’s approval will increase availability and insurance coverage.

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