Artera vs Freenome
Freenome's SimpleScreen CRC starts with a blood draw from an adult aged 45 or older at average risk, and a positive result goes to colonoscopy. ArteraAI starts from the biopsy slide of a patient already diagnosed with prostate or breast cancer. Primary care screening programs and radiation oncology practices order from separate vendors.
FDA approved P250029 in July 2026 on the PREEMPT CRC trial of more than 48,000 asymptomatic adults. The vendor reports 81.1% sensitivity for colorectal cancer, 13.7% for advanced precancerous lesions and 90.4% specificity for advanced neoplasia. Abbott is to commercialize the test exclusively in the US and handle reimbursement, and the approval release gives no price or CLIA lab.
A radiation oncology practice weighing androgen deprivation for prostate cancer would order Artera. Artera says the analysis uses existing H&E slides with no additional staining and returns results within one to two days of the specimen reaching its CLIA lab.
Pathology · Reviewed November 2, 2026
When to pick each one
Artera
- Artera says it works from existing H&E slides
- Artera says results come 1 to 2 days after receipt
Freenome
- Blood test for adults 45 and older at average risk
- PMA P250029 approved, July 2026
- Abbott to commercialize in the US
Score
Each row shows points earned of points available under the published rubric.
Artera
65of 100
Freenome
40of 100
| Dimension | Artera | Freenome | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 10 / 10 | 0 / 10 | +10 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 14.7 / 21 | 0 / 21 | +14.7 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 0 / 7.8 | +7.8 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Artera
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Freenome
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Artera
FDA decisions
K254115 (opens in new tab)510(k)2026-05-04
ArteraAI Breast
DEN240068 (opens in new tab)De Novo2025-07-31
ArteraAI Prostate
Peer-reviewed
4 PubMed records name Artera.
- Multi-institutional Patient-level Comparison of Decipher Genomic Classifier and Artera Multimodal Artificial Intelligence (MMAI) in Prostate Cancer. (opens in new tab)
- External validation of a digital pathology-based multimodal artificial intelligence-derived prognostic model in patients with advanced prostate cancer starting long-term androgen deprivation therapy: a post-hoc ancillary biomarker study of four phase 3 randomised controlled trials of the STAMPEDE platform protocol. (opens in new tab)
- A multicentre implementation trial of an Artificial Intelligence-driven biomarker to inform Shared decisions for androgen deprivation therapy in men undergoing prostate radiotherapy: the ASTuTE protocol. (opens in new tab)
Freenome
FDA decisions
P250029 (opens in new tab)PMA2026-07-24
SimpleScreen CRC
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Artera | Freenome |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2014 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
Digital pathology workflows with FDA-cleared cancer detection (prostate, breast, colon), IHC scoring (HER2, Ki67), and AI-powered image management. Tempus, PathAI, Proscia dominate.


