Guideline-recommended screening has changed what is possible for several cancers by helping detect cancer earlier, when it may be easier to treat.
Yet too many eligible patients never enter, or remain up to date with, recommended screening.
Participation rates in lung and colorectal cancer screening illustrate this gap. Fewer than one in five people eligible for lung cancer screening based on smoking history and other risk factors are up to date with screening using low-dose CT.1 Nearly two in five eligible adults are not up to date with colorectal cancer screening.2
The demands of screening can affect participation
Depending on the method, screening may require an imaging appointment, procedure preparation, transportation, and time away from work or caregiving. At-home options remove some demands but still must be received, completed, and returned.
These barriers can accumulate, and patients facing more of them are less likely to get screened.3,4 As a result, whether an eligible patient completes screening may depend on the complexity of their screening needs, time, resources, and flexibility available to them.
Blood-based testing can provide another point of access because a blood draw can often fit into routine care. But its role should be additive. For instance, for colorectal cancer, the American Cancer Society recommends blood-based screening for people who decline or have not completed a preferred stool-based test or colonoscopy. Importantly, a positive blood-based screening result still requires colonoscopy to complete screening.5
More broadly, blood-based screening can help eligible patients enter screening, but it should not replace established methods or the guideline-recommended next step after a positive result.
Personalized Cancer Detection: a different approach to blood-based screening
As blood-based screening options expand, health systems must also consider how different approaches account for the biology and clinical pathways of different cancers.
Single-cancer early detection, or SCED, tests are designed to screen for one cancer. Their indication-specific focus can provide a clear connection to cancer-specific follow-up screening. As health systems add SCED tests for more cancers, however, they may need to operationalize separate programs involving different laboratories, ordering processes, and pathways.
Multi-cancer early detection, or MCED, tests look for signals associated with many cancers in one assay, often including some cancers without established screening methods. But performance can vary by cancer, and a positive result requires diagnostic evaluation that may involve multiple procedures to investigate the possible site of origin and determine whether cancer is present.
Freenome brings a different approach to the space: Personalized Cancer Detection (PCD). PCD combines risk-based screening with a portfolio of indication-specific blood-based tests. When multiple tests are appropriate, they can be completed through a single blood draw. This approach allows care teams to offer the test, or tests, relevant to a patient’s risk, screening needs, and circumstances.
SimpleScreenTM: Building an indication-specific portfolio
Freenome delivers Personalized Cancer Detection through the SimpleScreen portfolio of indication-specific blood-based screening tests. The initial portfolio will include SimpleScreen Lung and SimpleScreen CRC, both coming soon. Additional cancer indications are in development.
SimpleScreen CRC is FDA approved for colorectal cancer screening in average-risk adults ages 45 and older. A positive result should be followed by colonoscopy.7 SimpleScreen Lung is a laboratory-developed blood test for people eligible for lung cancer screening. A positive result should be followed by low-dose CT.8
Behind the portfolio is the Freenome Discovery Platform. Different cancers can produce different biological signals. This multiomics platform examines several types of biological information, including DNA, RNA, proteins and other cancer-related biomarkers. Artificial intelligence and machine learning help identify the signals most informative for each indication.
This allows each SimpleScreen test to use the biological signals most relevant to its intended cancer instead of applying the same biomarker approach across every indication. Data generated over time can also help refine existing tests and inform new ones.
What this means for health systems
For health systems, the value of Personalized Cancer Detection lies in how these elements work together: the accessibility of blood-based screening, the ability to offer the indication-specific test(s) relevant to each patient’s needs, and one blood draw when multiple tests are appropriate. With additional SimpleScreen tests in development, PCD gives leaders a longer-term framework for screening that is patient-centered and responsive to population needs.
PCD offers a path to build on what already works in screening, help more eligible patients participate, and address more cancer risks over time.
Learn more about Personalized Cancer Detection and the SimpleScreen portfolio.
The SimpleScreen Lung laboratory developed test has not been reviewed or cleared/approved by U.S. Food and Drug Administration (FDA)
Precaution: Based on data from clinical studies, SimpleScreen CRC has limited detection (57%) of Stage I colorectal cancer (64% when U.S. 2020 Census age-sex adjusted) and does not detect 87% of advanced precancerous lesions (86% when U.S. 2020 Census age-sex adjusted). One out of 10 patients with a negative SimpleScreen CRC result may have a precancer that would have been detected by a screening colonoscopy.
References
- Bandi P, Star J, Ashad-Bishop K, et al. Lung cancer screening in the US, 2022. JAMA Intern Med. 2024;184(8):882-891. doi:10.1001/jamainternmed.2024.1655
- King SC, King J, Thomas CC, Richardson LC. Baseline estimates of colorectal cancer screening among adults aged 45 to 75 years, Behavioral Risk Factor Surveillance System, 2022. Prev Chronic Dis. 2025;22:250175. doi:10.5888/pcd22.250175
- Cavers D, Nelson M, Rostron J, et al. Understanding patient barriers and facilitators to uptake of lung screening using low-dose computed tomography: A mixed methods scoping review of the current literature. Respir Res. 2022;23:374. doi:10.1186/s12931-022-02255-8
- Zhu X, Weiser E, Jacobson DJ, et al. Provider-perceived barriers to patient adherence to colorectal cancer screening. Prev Med Rep. 2022;25:101681. doi:10.1016/j.pmedr.2021.101681
- Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening: An update to the American Cancer Society guideline, 2026. CA Cancer J Clin. 2026. doi:10.3322/caac.70083
- National Cancer Institute. Questions and Answers About Multi-Cancer Detection Tests. Accessed August 5, 2026.
- Freenome. FDA Approves Freenome’s SimpleScreen CRC Blood-Based Screening Test. July 27, 2026.
- Data on file.
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