---
title: "FDA approves SimpleScreen blood test to expand colorectal cancer screening options"
id: "medical-news-today-0-fda-approves-second-blood-test-to-help-close-colorectal-cancer-screening-gap"
canonical_url: "https://medichelpline.com/clinical-feed/medical-news-today-0-fda-approves-second-blood-test-to-help-close-colorectal-cancer-screening-gap"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Medical News Today"
source_url: "https://www.medicalnewstoday.com/articles/fda-approves-second-blood-test-help-close-colorectal-cancer-screening-gap/"
published_at: "2026-08-02T09:09:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA approves SimpleScreen blood test to expand colorectal cancer screening options
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/medical-news-today-0-fda-approves-second-blood-test-to-help-close-colorectal-cancer-screening-gap
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Medical News Today
- **Source URL:** [Original Journal Publication](https://www.medicalnewstoday.com/articles/fda-approves-second-blood-test-help-close-colorectal-cancer-screening-gap/)
- **Published At:** 2026-08-02T09:09:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- Colorectal cancer remains highly preventable when detected early, but millions of eligible U.S. adults are overdue for screening despite guideline recommendations for average-risk adults aged 45 and older. - Traditional options include **colonoscopy** (the gold standard) and stool-based tests; many people avoid these due to preparation, discomfort, embarrassment, inconvenience, cost, access, or fear. - Blood-based screening has been developed as an additional option to reduce barriers and increase uptake; the FDA approved the first blood test (Shield) in 2024 and a second, Freenome’s **SimpleScreen**, in July 2026. - In the PREEMPT CRC study of more than 48,000 participants, SimpleScreen detected about **8 in 10 colorectal cancers** and returned negative results for roughly **9 in 10 people without colorectal cancer or advanced precancerous lesions**. - SimpleScreen analyzes blood for patterns of **CpG methylation**—DNA methylation changes that can arise early in cancer development—and results are reported to the ordering clinician, typically within about two weeks. - A positive SimpleScreen result requires a follow-up diagnostic **colonoscopy** to complete the screening pathway. - Experts note that no single screening method fits everyone; offering a range of acceptable, evidence-based options and clinician recommendation can improve screening participation. - Blood-based tests may be less intimidating and more convenient for some patients, potentially closing parts of the screening gap, but they are complementary to, not replacements for, established diagnostic procedures.
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Cancer](https://www.medicalnewstoday.com/articles/colon-cancer-recurrence) * [Colon Polyp Types](https://www.medicalnewstoday.com/articles/types-of-colon-polyps) # FDA approves second blood test to help close colorectal cancer screening gap Written by Peter Morales-Brown on August 2, 2026 — Fact checked by Jill Seladi-Schulman, Ph.D. ![A registered nurse taking a blood draw.](https://media.post.rvohealth.io/wp-content/uploads/sites/3/2026/08/getty_2211671794_header_1296x728-1024x575.jpg)[Share on Pinterest](https://www.pinterest.com/pin/create/button/?url=https%3A%2F%2Fwww.medicalnewstoday.com%2Farticles%2Ffda-approves-second-blood-test-help-close-colorectal-cancer-screening-gap&media=https%3A%2F%2Fmedia.post.rvohealth.io%2Fwp-content%2Fuploads%2Fsites%2F3%2F2026%2F08%2Fgetty_2211671794_header_1296x728-1024x575.jpg&description=Colorectal%20cancer%3A%20FDA-approved%202nd%20blood%20test%20can%20close%20screening%20gap "Share on Pinterest")Following FDA approval, could blood tests, such as SimpleScreen, help increase colorectal cancer screening uptake? adamkaz / Getty Images * **Despite colorectal cancer being one of the most preventable and treatable cancers when detected early through routine screening, millions of eligible Americans remain overdue for screening.** * **Existing screening methods, such as colonoscopy and stool-based tests, are highly effective, but many people avoid them because of preparation difficulties, discomfort, embarrassment, inconvenience, or fear of the results.** * **The FDA approval of Freenome’s SimpleScreen CRC blood test provides a new screening option for average-risk adults, complementing current options.** * **In clinical studies, the test detected roughly 8 in 10 colorectal cancers.** At present, [colorectal cancer](https://www.medicalnewstoday.com/articles/155598) is the [second leadingTrusted Source](https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer) cause of cancer-related deaths worldwide, and [early-onset colorectal cancer](https://www.medicalnewstoday.com/articles/colon-cancer-younger-adults-signs-and-symptoms) is the [leading causeTrusted Source](https://jamanetwork.com/journals/jama/fullarticle/2844189) of cancer-related death among males and females under age 50. Current [colorectal cancer screening guidelinesTrusted Source](https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70083) advise that average-risk adults ages 45 years and older should undergo regular screening. However, despite this recommendation and colorectal cancer being one of the most [preventable cancers](https://colorectalcancer.org/screening-prevention) through screening, an estimated [60 million](https://pmc.ncbi.nlm.nih.gov/articles/PMC10980958/) eligible individuals in the U.S. do not participate. For many years, experts have considered [colonoscopies](https://www.medicalnewstoday.com/articles/colonoscopy) as the [gold standardTrusted Source](https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34622) for colorectal cancer screening. [Stool-based tests](https://www.medicalnewstoday.com/articles/fit-test) have also become increasingly popular because they can be completed at home. Yet, many eligible adults are reluctant to undergo screening. People may consider screening a [taboo or stigmatized](https://pmc.ncbi.nlm.nih.gov/articles/PMC9021163/) topic. Potential barriers may include [preparation](https://www.medicalnewstoday.com/articles/what-to-eat-to-prepare-for-a-colonoscopy), fear, discomfort, embarrassment, taking time off work, limited access to healthcare, cost concerns, lack of awareness of screening recommendations, and a tendency to delay preventive care when no symptoms are present. Recognizing that no single screening method appeals to everyone, researchers have developed blood-based screening tests designed to make colorectal cancer screening more convenient. In 2024, the U.S. Food and Drug Administration (FDA) approved the [Shield blood testTrusted Source](https://www.fda.gov/medical-devices/recently-approved-devices/shield-p230009). In July 2026, the FDA also approved Freenome’s [SimpleScreen](https://www.freenome.com/newsroom/fda-approves-freenomes-simplescreen-crc/) colorectal cancer blood-based screening test. In the large [PREEMPT CRC clinical studyTrusted Source](https://jamanetwork.com/journals/jama/fullarticle/2834891), which involved more than 48,000 participants, the SimpleScreen blood test correctly identified roughly 8 out of 10 colorectal cancers and produced negative results for about 9 out of 10 people without colorectal cancer or advanced precancerous lesions. The approval offers another screening option, which some people may find significantly less intimidating than scheduling a colonoscopy or completing a stool test at home. This convenience may encourage previously unscreened people to participate, potentially leading to more cancers being detected earlier, when treatment is most effective. _Medical News Today_ spoke with [Paul Limburg](https://www.linkedin.com/in/paul-limburg/), MD, MPH, Chief Screening Medical Officer, Screening, Abbott Cancer Diagnostics, about how blood-based colorectal cancer screening works and compares to other options, if it can help close the screening gap, and how it fits into routine cancer screening. ### How does this new blood test compare with colonoscopies and stool-based screening tests such as Cologuard? “Colorectal cancer (CRC) screening is not one-size-fits-all, and different patients have different preferences. The current [American Cancer Society](https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70083) guideline identifies stool-based testing, including the Cologuard Plus test, and visual examinations such as colonoscopy as preferred screening options,” Limburg told _Medical News Today_. Earlier research [found](https://pmc.ncbi.nlm.nih.gov/articles/PMC9852355/) that most people prefer stool-based screening to colonoscopy. However, more recent evidence [suggests](https://pmc.ncbi.nlm.nih.gov/articles/PMC12818849/) that many would generally prefer blood-based screening tests over other options, which may help to improve CRC screening uptake, particularly among those who are unscreened or overdue for screening. “Ultimately, screening decisions should be made between patients and their healthcare providers based on each individual’s circumstances and preferences,” Limburg added. A healthcare professional’s recommendation plays a [vital role](https://www.nyc.gov/assets/doh/downloads/pdf/cancer/talking-about-colorectal-cancer-screening-with-patients.pdf) in screening. Framing CRC screening as a routine, effective, and manageable preventive health measure and emphasizing that the best screening test is the one they are willing and able to complete can help increase screening uptake. ### How does this blood test actually detect signs of colorectal cancer? “SimpleScreen CRC is a blood-based screening test that detects signals associated with CRC,” Limburg said. After a simple blood draw, the sample is sent to a laboratory, where it is tested for specific DNA changes that may indicate the presence of cancer or precancerous cells. In particular, the [SimpleScreen test](https://jamanetwork.com/journals/jama/fullarticle/2834891) detects patterns of cytosine-phosphate-guanine (CpG) methylation. These changes often occur early in cancer development, making them useful biomarkers for cancer screening. “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. ### With nearly 60 million eligible Americans remaining
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