Personalized Cancer Detection. Built around the individual.
Personalized Cancer Detection is Freenome’s approach to blood-based cancer screening. It combines risk-based screening with indication-specific blood-based tests, all through a simple blood draw. The SimpleScreen™ portfolio starts with SimpleScreen Lung and SimpleScreen CRC, with additional indications in development.
Explore the SimpleScreen portfolio.
SimpleScreen brings blood-based screening options together in one portfolio. Select a test to learn more.
What it is:
Blood-based screening test for lung cancer
Who it's for:
Adults ages 50-80 with a ≥20 pack-year history of smoking who have not completed lung cancer screening with low-dose CT.
- 85%sensitivity
- 50%specificity
If the result is positive:
Follow up with low-dose CT.
If the result is negative:
Continue with screening plans based on clinical judgment. When appropriate, repeat SimpleScreen Lung every year if the result is negative.
What it is:
An FDA-approved blood-based screening test for colorectal cancer (CRC)Available as an add-on to SimpleScreen Lung orders when both tests are appropriate for a patient
Who it's for:
Adults ages 45 and older at average risk for colorectal cancer who have not completed colonoscopy or stool-based colorectal cancer screening
- 81%sensitivity for CRC
- 90%specificity for advanced colorectal neoplasia
- 14%sensitivity for advanced precancerous lesions (APLs)
- 31%sensitivity for APLs with high-grade dysplasia
If the result is positive:
Follow up with a colonoscopy.
If the result is negative:
Continue with screening plans based on clinical judgment. If SimpleScreen CRC is elected again, the test is repeated every three years when the result is negative.
Additional indications
The SimpleScreen portfolio will grow as Freenome launches additional cancer screening tests.
#Reported sensitivities were adjusted for stage and subtype to address differences between the evaluation cohort and literature-reported distributions
*Study results of observed sensitivity for CRC was 79.2% and specificity for ACN was 91.5%, which was then adjusted to age and sex distribution of 2020 US census population.
References: 1. Freenome internal clinical validation analysis. Data on file. 2. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA–Based Blood Test to Screen for Colorectal Cancer. JAMA. 2025;334(1):56-63. doi:10.1001/jama.2025.7515. 3. Shaukat A, Meng Z, Kutnik K, et al. Age- and sex-adjusted performance of a colorectal cancer screening test using US census distribution. J Natl Cancer Inst. Published online January 9, 2026:djag007. doi:10.1093/jnci/djag007
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.
Intended Use: The SimpleScreen™ CRC test is a qualitative, in vitro diagnostic test intended to detect molecular signals associated with colorectal cancer. SimpleScreen CRC utilizes circulating cell-free DNA from plasma of peripheral whole blood collected in the SimpleScreen CRC blood collection kit.
SimpleScreen CRC is indicated for colorectal cancer screening in adults aged 45 years and older who are at average risk for the disease. Patients with a positive result should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
Additional information about SimpleScreen CRC:
- Provider Brochure
- Patient Information Sheet
- SimpleScreen CRC Instructions for Use
- Blood Collection Kit Instructions for Use
Additional information about SimpleScreen Lung: