Can a Blood Test Make Colorectal Cancer Screening Easier? What Freenome’s New Data Shows

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Blood-based colorectal screening concept with a blood vial, laboratory pathway, and colon outline

Colorectal cancer is one of the most preventable serious diseases—but prevention depends on people actually showing up for screening. Colonoscopy works well when people use it, yet most eligible adults in the United States skip it. A combination of preparation requirements (a day of bowel cleansing), time off work, sedation, cost, and anxiety keeps participation well below what public-health guidelines recommend. The result is that cancers and precancerous lesions that could have been found early are instead found late, or not at all.

That access gap is what Freenome, a California-based biotechnology company, is trying to address with SimpleScreen CRC—a blood-based colorectal cancer screening test. On July 9, 2026, the company reported top-line results from an updated version of the test, based on the large PREEMPT CRC study. The numbers are worth reading carefully, because they come with important context about what they can and cannot tell us at this stage.

The study behind the numbers

PREEMPT CRC (ClinicalTrials.gov identifier: NCT04369053) is a large prospective study that enrolled 48,995 asymptomatic, average-risk adults between ages 45 and 85, recruited at more than 200 sites across the United States. All participants were already scheduled for routine screening colonoscopy. Blood samples were collected ahead of the procedure so that the SimpleScreen CRC results could later be compared against the colonoscopy findings.

The updated validation analysis included blinded, previously unevaluated samples from PREEMPT CRC 1 alongside samples that had been evaluated in earlier analyses. The case counts available for analysis included more than 85 colorectal cancer cases, more than 1,500 advanced precancerous lesions (APLs), and more than 150 APLs with high-grade dysplasia. All the reported performance figures were adjusted to match the age and sex distribution of the U.S. Census, a step intended to make the estimates more representative of the broader screening-eligible population rather than just the enrolled group.

Importantly, what was released on July 9 is a top-line summary from the company. Full methods, statistical analyses, and complete subgroup data have not yet appeared in a peer-reviewed scientific journal.

What the test showed

The table below contains the performance values Freenome reported.

Measure Reported value

Overall CRC sensitivity 80.4%

Stage I sensitivity 52%

Stage I T1 sensitivity 39.9%

Stage I T2 sensitivity 81.2%

Stage II sensitivity 100%

Stage III sensitivity 97.3%

Stage IV sensitivity 100%

Advanced precancerous lesion (APL) sensitivity 18.2%

APL with high-grade dysplasia sensitivity 41.9%

Specificity (participants with no findings on colonoscopy) 90%

Source: Freenome press release, July 9, 2026. Values adjusted to U.S. Census age/sex distribution. APL = advanced precancerous lesion.

Screening pathway from blood draw to laboratory analysis and confirmatory colonoscopy

Understanding sensitivity and specificity

Two numbers anchor any screening test: sensitivity and specificity. They are worth defining plainly because they are often misread.

Sensitivity asks: of the people who truly have the condition, what fraction does the test correctly flag as positive? An 80.4% overall CRC sensitivity means that in this study, the test detected roughly 80 out of every 100 colorectal cancer cases in the sample. The remaining approximately 20 were not detected—these are false negatives, meaning people with cancer whose blood test came back negative.

Specificity asks: of the people who genuinely do not have the condition, what fraction does the test correctly clear as negative? A 90% specificity, measured here among participants with no findings on colonoscopy, means roughly 9 out of 10 truly negative individuals received a negative blood test result. The remaining approximately 1 in 10 received a positive result despite having no cancer or precancerous lesion—a false positive, which would prompt a follow-up colonoscopy.

Neither figure is a guarantee. These are properties of the test as measured in a particular study population. How the numbers translate to a different population, a different laboratory setting, or routine clinical practice involves additional unknowns.

Why 80.4% is not “80% of cancers found everywhere”

A sensitivity figure comes from a defined study cohort with a specific mix of cancer stages, patient ages, and other characteristics. Even after adjusting for the U.S. Census age and sex distribution, real-world performance can differ for several reasons: how blood samples are collected and handled in community labs may vary from research protocols; the mix of cancer stages in a given community may differ from the study cohort; and other biological or demographic factors may influence biomarker levels in ways not fully captured here. A controlled validation study is the essential starting point for understanding a test—it is not the same as confirmed performance across every clinic and every patient type.

The harder question: precancerous lesions

The most important goal of colorectal cancer screening is not only finding cancer—it is catching disease before it becomes cancer. Advanced precancerous lesions (APLs) are growths that can progress to colorectal cancer if left untreated. Detecting and removing them during colonoscopy is central to why colonoscopy has such a strong track record for prevention.

The 18.2% APL sensitivity figure is the most significant limitation in this data release. It means the blood test detected fewer than 1 in 5 advanced precancerous lesions in this validation. Among the subset of APLs with high-grade dysplasia—the lesions at greatest risk of becoming cancer—sensitivity reached 41.9%, but that still means the majority were not detected by the blood test.

This does not mean a test with these characteristics is without potential value. A widely accessible blood test that removes barriers to screening entry and catches a meaningful share of established cancers could still reach patients who would otherwise receive no screening at all. But the precancerous lesion detection gap is the aspect of this profile that clinicians, patients, and regulators will weigh most carefully, because it bears directly on the test’s capacity to prevent rather than merely detect cancer.

Stage-specific numbers and why they require caution

The stage-specific sensitivity values are eye-catching: 100% for Stage II, 97.3% for Stage III, and 100% for Stage IV. These suggest the test performs well when colorectal cancer is more advanced—a pattern that broadly aligns with the general expectation that blood-based biomarkers tend to produce stronger signals when tumor burden is higher.

However, the overall validation included more than 85 CRC cases. That number, spread across four stages, means each individual stage category is based on a small number of cases. When a stage category has few cases, a single case falling on either side of a detection threshold can shift the percentage substantially. The 100% figures for Stage II and Stage IV should be read as preliminary estimates from limited case counts, not as stable, well-established values. Stage I sensitivity at 52%—and particularly 39.9% for Stage I T1 tumors—is also where early detection remains most challenging, both for blood-based tests and more broadly.

Colonoscopy is the reference, not the competition

SimpleScreen CRC was validated against colonoscopy, which is the established reference standard for colorectal cancer screening in the United States. Colonoscopy is not only a diagnostic tool—it also allows physicians to remove precancerous polyps during the same procedure. No blood-based screening test currently does that.

The practical model being explored for blood-based colorectal tests is different: a blood draw serves as an accessible first step, and those who test positive then receive a colonoscopy. Whether that pathway improves overall population-level outcomes compared to existing strategies—or reaches sufficiently different populations to add net benefit—depends on evidence that is still being developed. The blood test is not presented here, and should not be understood, as a replacement for colonoscopy.

Where things stand with the FDA

Freenome submitted a premarket approval (PMA) application for the first-generation SimpleScreen CRC to the FDA in August 2025. For the updated test described in this readout, the company has stated its intention to file a supplemental PMA. A PMA submission begins a regulatory review process; it is not approval. The updated test is not currently approved for clinical use, and the timeline and outcome of FDA review are not yet known.

What we don’t know yet

The July 9 release is a top-line summary, not a peer-reviewed publication. Full methods, complete statistical breakdowns, and detailed subgroup analyses—including how performance may have varied across age groups, sexes, racial and ethnic groups, or different lesion types—are not yet publicly available. Until that peer-reviewed publication appears, some important technical and contextual questions cannot be answered from the information currently in the public domain.

This article is for public education about scientific and medical research findings. It does not constitute medical advice, a medical recommendation, or a clinical guideline. Decisions about cancer screening should be made in consultation with a qualified healthcare provider, taking individual health circumstances into account. This article does not constitute investment advice or a recommendation regarding any company, security, or product.

References

• Freenome. “Freenome Reports Top-Line Readout of Updated SimpleScreen CRC Colorectal Cancer Screening Blood Test: Met All Primary and Secondary Endpoints.” Press release, July 9, 2026. freenome.com ↗

• ClinicalTrials.gov. PREEMPT CRC. NCT04369053. clinicaltrials.gov ↗