Freenome
Blood based early cancer detection built on a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers and applies machine learning classifiers to detect cancer signals in circulating tumor DNA at single base methylation resolution. SimpleScreen CRC, the colorectal screening test, has a Premarket Approval application under FDA review submitted August 2025, with the company anticipating a decision in 2026; it is not FDA approved. The pivotal PREEMPT CRC validation study was published in JAMA in 2025, and blood based testing was included in the American Cancer Society's updated colorectal screening guideline in 2026. An updated assay version reported 85 percent sensitivity for colorectal cancer and 22 percent for advanced precancerous lesions at 90 percent specificity in a 966 sample head to head validation. Under an exclusive license agreement, Exact Sciences holds US commercial rights, and a separate commercial collaboration with Abbott covers bringing the test to market.
Capability Axes
Machine learning classifiers on multiomic signal are what convert a blood draw into a cancer result, and the company is expanding into fragment level deep learning and a methylation foundation model. Held back from A for the same reason as GRAIL: this is a wet lab assay plus a classifier, and the assay chemistry is as load bearing as the model. The vendor's own reporting of assay upgrades improving limit of detection and signal to noise makes that explicit.
The pivotal PREEMPT CRC validation study was published in JAMA in 2025, and blood based testing was subsequently included in the American Cancer Society's updated colorectal cancer screening guideline, which is independent recognition rather than vendor assertion. A 966 sample head to head validation reported 85 percent sensitivity for colorectal cancer and 22 percent for advanced precancerous lesions at 90 percent specificity. Graded on evidence design and venue; this index does not re verify the underlying results.
Positioning is stated precisely and without overclaim. The Premarket Approval application for SimpleScreen CRC was submitted in August 2025 and remains under FDA review, with the company anticipating a decision in 2026 and stating an intent to file a supplemental PMA for the next generation assay. The test is consistently described as under review rather than approved, and the lung product is identified as a laboratory developed test.
No public pricing. Contact the vendor. Commercial structure is unusual and material to buyers: under an exclusive license agreement, Exact Sciences holds US commercial rights to SimpleScreen CRC and would commercialize it upon approval, with a separate commercial collaboration with Abbott. A buyer's commercial counterparty may therefore not be Freenome.
Clearly bounded: blood based screening in average risk colorectal cancer populations, with a lung indication in development. The company states explicitly that no single technology detects every cancer, which is an unusually candid scope limitation for this category.
Pricing
Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.
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Per test, commercialized through licensed partners upon approval | — | — | Vendor Published |
Commercial structure is material here. Under an exclusive license agreement, Exact Sciences holds US commercial rights to SimpleScreen CRC and would commercialize it upon FDA approval, with a separate commercial collaboration with Abbott. A buyer's commercial counterparty may therefore not be Freenome. No pricing is published.