SimpleScreen CRC Blood Test Cleared by FDA for Average-Risk Adults

The FDA has cleared Freenome's SimpleScreen CRC blood test. It is a new screening option for average-risk adults. The approval landed in July 2026. It follows the 2024 nod for the Shield blood test.

In the PREEMPT CRC study of more than 48,000 participants, the SimpleScreen CRC blood test picked up about 8 in 10 colorectal cancers. It returned a negative result in about 9 in 10 people without cancer or advanced precancerous lesions.

Paul Limburg, MD, MPH, Chief Screening Medical Officer at Abbott Cancer Diagnostics, framed the launch as a way to expand choice.

Limburg told Medical News Today: "Colorectal cancer (CRC) screening is not one-size-fits-all, and different patients have different preferences." He added that the American Cancer Society guideline lists stool-based testing (including Cologuard Plus) and colonoscopy as preferred options.

Why a new blood-based option matters

Colorectal cancer is the second leading cause of cancer-related deaths worldwide. Early-onset colorectal cancer is now the leading cause in males and females under age 50. Current guidelines advise regular screening for average-risk adults ages 45 and older.

Despite that, roughly 60 million eligible Americans skip screening. Colonoscopy has long been the gold standard. Stool-based tests have gained ground because patients can do them at home. Yet many eligible adults still skip screening.

Common barriers include preparation, fear, discomfort, embarrassment, and time off work. Others include limited access to healthcare, cost, and lack of awareness. Some patients delay preventive care when no symptoms are present. Others see screening as a taboo topic.

What the SimpleScreen CRC blood test detects

"SimpleScreen CRC is a blood-based screening test that detects signals associated with CRC," Limburg said.

After a simple blood draw, the sample runs at a lab. Analysts test the sample for specific DNA changes. Those changes may point to cancer or precancerous cells.

The SimpleScreen CRC blood test targets patterns of cytosine-phosphate-guanine (CpG) methylation. These changes often show up early in cancer growth. That makes them useful biomarkers.

"Results are generally available within approximately two weeks and are shared with the ordering healthcare provider, who can review the findings and discuss appropriate next steps. To complete the screening process, a positive result requires a follow-up colonoscopy," Limburg explained.

PREEMPT CRC performance snapshot

The pivotal PREEMPT CRC study enrolled more than 48,000 participants. The SimpleScreen CRC blood test identified roughly 8 out of 10 colorectal cancers. It returned a negative result in about 9 out of 10 people without colorectal cancer or advanced lesions.

That performance sits behind stool-based tests and colonoscopy. It sits well above no screening at all. Adherence data help fill the gap: a real-world study suggests blood-based screening adherence could reach 95%.

Where the SimpleScreen CRC blood test fits in guidelines

The American Cancer Society recently updated its CRC screening guideline for average-risk adults. The update keeps stool-based testing and colonoscopy as preferred options. Blood tests move in for those who decline or skip a preferred option.

"With the addition of the SimpleScreen CRC test, healthcare providers have another option for eligible patients who may decline or not complete a guideline-preferred screening test, creating more opportunities to engage people who otherwise might not get screened," Limburg said.

Two speciality groups echoed the SimpleScreen CRC blood test framing. The American Gastroenterological Association (AGA) and the American Society for Gastrointestinal Endoscopy (ASGE) both accept that blood tests could lift participation. Both also conclude current blood tests are less effective than established options. They should sit in reserve for patients who otherwise refuse recommended screening.

Outlook for CRC screening

Earlier research showed most people preferred stool-based screening to colonoscopy. More recent data suggest that many would prefer a blood test. That shift may lift uptake among the unscreened and overdue. Willingness runs highest when the test is free or covered by health insurance.

"CRC screening is not one-size-fits-all, and expanding choice gives healthcare providers additional opportunities for informed decision-making with patients and to identify the highest-performing option that allows more people to complete screening," Limburg concluded.

For primary care, gastroenterology, and preventive medicine teams, the SimpleScreen CRC blood test is a new tool for engaging patients who skip preferred options. Coverage on Medigear.uk tracks how the test reshapes CRC screening.

Source: Originating coverage based on Medical News Today reporting on the U.S. Food and Drug Administration (FDA) July 2026 approval of Freenome's SimpleScreen colorectal cancer (CRC) blood-based screening test, with PREEMPT CRC clinical study data and expert commentary from Paul Limburg, MD, MPH, Chief Screening Medical Officer at Abbott Cancer Diagnostics.