FDA Clears Second Blood-Based Test to Help Close the Colorectal Cancer Screening Gap

SimpleScreen CRC is approved for average-risk adults 45 and older who are referred for screening by a healthcare provider, Freenome announced alongside Abbott, which will commercialize the test in the U.S. this fall. With approval, the test meets Medicare's coverage criteria and is expected to be named in the American Cancer Society's screening guidelines.

The shape of the market now echoes the early stool-test era, when at-home kits gradually took their place beside colonoscopy as accepted options. Shield opened the blood-based category in 2024 as the first test of its kind approved for primary screening. SimpleScreen is the second, and that matters: it signals a category maturing from novelty into a genuine tier of the screening menu rather than a single outlier.

Screening is recommended to begin at age 45 for people at average risk, a milestone worth mapping against the other health priorities that shift with each decade.

For that wider view, see the one health priority to rank first in your 20s, 30s, 40s and beyond.

SimpleScreen earned approval on the strength of PREEMPT CRC, described as the largest prospective validation study ever run for a blood-based colorectal test. It enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 across over 200 sites, each already scheduled for a screening colonoscopy that served as the yardstick.

The results, published in JAMA, were consistent. In an analysis adjusted to the U.S. population, the test detected colorectal cancer with 81.1% sensitivity and produced correct negatives with 90.4% specificity. In plainer terms, it caught about 8 in 10 cancers and correctly cleared about 9 in 10 people who did not have cancer or an advanced precancerous lesion. Those are respectable numbers for a blood draw. They also come with a significant asterisk.

That asterisk is precancer. In the same trial, SimpleScreen detected advanced precancerous lesions with just 13.7% sensitivity, roughly one in seven, rising to 30.7% for the highest-risk precancerous growths. The first blood test carries the same weakness: Guardant's Shield, validated in a study of more than 20,000 adults, caught about 83% of cancers but only around 13% of advanced precancerous lesions, Guardant Health reported at its own approval.

This is where a blood test and a colonoscopy part ways. A colonoscopy does not just find cancer; it finds and removes polyps before they can turn into cancer, which is why it is treated as the benchmark. A blood test, by design, is better at detecting disease that is already present than at heading it off.

The broader point, that no screening test is free of trade-offs, is one the evidence keeps returning to.

The same tension plays out in a very different setting in is a full-body MRI actually worth it? What the evidence really says.

Each screening path asks something different of the patient, and each has a distinct strength. Colonoscopy has long been treated as the gold standard because it can detect and remove polyps in a single visit, while stool-based tests such as FIT and Cologuard trade some of that power for the convenience of a sample collected at home.

No option is strictly best. The blood test is the lowest-friction entry point and the weakest at catching precancer. The colonoscopy is the most thorough and the most demanding. The stool tests sit somewhere in between.

For readers weighing symptoms rather than routine timing, blood in stool: 10 possible causes and when to see a doctor covers when a symptom is the reason to call a clinician.

The reason the approval matters has less to do with the test than with the gap it is meant to narrow. Researchers estimate that up to 60 million screening-eligible Americans are overdue or have never been screened. Fight Colorectal Cancer notes that about 90% of colorectal cancer deaths are preventable, yet the disease is still projected to kill more than 55,000 people in the U.S. this year.

The barriers are rarely about doubting that screening works. They cluster around friction and discomfort:

• Bowel prep, sedation, and the invasiveness of a colonoscopy
• Fear of the procedure itself, or of what it might find
• Embarrassment, and a lingering sense that the topic is taboo
• Time off work and limited access to care
• Cost concerns and low awareness of when screening should begin
• The very human tendency to postpone preventive care when nothing hurts

The disease is also shifting younger, with early-onset colorectal cancer rising among adults under 50, which widens the population that screening decisions now touch.

For more figures that reframe how people think about their health, 9 health statistics from 2026 that surprised even researchers is a useful companion read.

Guidelines have made room for blood tests, but pointedly as a second string. The American Cancer Society updated its guidance for average-risk adults to include blood-based screening for people who decline or do not complete a preferred option, with stool-based testing and colonoscopy still named as those preferred options.

"Colorectal cancer (CRC) screening is not one-size-fits-all, and different patients have different preferences," Paul Limburg, MD, MPH, chief screening medical officer at Abbott Cancer Diagnostics, told Medical News Today. "The current American Cancer Society guideline identifies stool-based testing, including the Cologuard Plus test, and visual examinations such as colonoscopy as preferred screening options."

Gastroenterology's professional bodies land in the same place. The American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy both hold that blood tests can lift participation among people who refuse other methods, while cautioning that current blood tests are less effective than established options and should generally be reserved for those otherwise unwilling to do a colonoscopy or stool test. The consensus, in short: better than no screening, but not a replacement for it.

The case for SimpleScreen rests on a premise its investigators state plainly. "The most effective screening test is the one a person will actually complete," said Aasma Shaukat, MD, MPH, a co-lead investigator on PREEMPT CRC and a professor at NYU Grossman School of Medicine. A blood-based option, she added, offers another way to reach unscreened patients and bring more of them into the fold, where cancers are caught earlier. Early real-world data hint at that upside, with one real-world analysis suggesting adherence to blood-based screening could reach as high as 95%, particularly when the test is free or covered by insurance.

The counterweight is just as plain. A test that misses most precancer, and that routes every positive back to a colonoscopy, functions as a bridge to screening rather than a replacement for the methods that catch disease earliest. Which trade-off makes sense depends on the person weighing it. As Limburg framed it, "the most appropriate screening approach depends on each patient's individual circumstances and should be determined in partnership with their healthcare provider."