Artera vs GRAIL
The NHS-Galleri randomized trial missed its primary endpoint, per 2026 coverage in Cancer Discovery and the BMJ, while the FDA advisory panel still voted 7 to 2, with one abstention, that Galleri's benefits outweigh its risks. Galleri's own site says the test has not been cleared or approved by the FDA. Primary care physicians adding a cancer-signal blood test for patients over 50 would order it as an addition to guideline-recommended screening, and it looks for signals from more than 50 cancer types.
Artera suits a urologist with a prostate biopsy in hand. ArteraAI Prostate is a De Novo-authorized software device, and the commercial test runs in Artera's CLIA lab on the same platform. A Lancet Digital Health external validation in advanced prostate cancer and a BMC Cancer multicentre implementation trial back it, though many authors are Artera-affiliated. A primary care physician ordering a screening blood test and a urologist ordering a prostate prognosis are making separate purchases, one before any diagnosis and one after a biopsy.
Pathology · Reviewed November 2, 2026
When to pick each one
Artera
- Lancet Digital Health validation in advanced prostate cancer
- Multicentre implementation trial in BMC Cancer
GRAIL
- Multi-cancer blood test for adults 50 and older
- Looks for signals from over 50 cancer types
Score
Each row shows points earned of points available under the published rubric.
Artera
65of 100
GRAIL
28of 100
| Dimension | Artera | GRAIL | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 0 / 18 | +18 |
| 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 | 8.4 / 21 | +6.3 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 7.8 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 0 / 5 | +2.5 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Artera
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
GRAIL
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
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)
GRAIL
FDA decisions
No FDA decision cited in our research as of November 2, 2026.
Peer-reviewed
1 PubMed record names GRAIL.
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Artera | GRAIL |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| 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.


