Artera vs Caris Life Sciences
Medical oncologists who need a companion diagnostic order from Caris. PMA P240010, approved in November 2024, covers MI Cancer Seek, a tissue sequencing assay whose indications include PIK3CA for Piqray and KRAS/NRAS wild-type for Vectibix. The MI Cancer Seek page puts GPSai and FOLFIRSTai outside that approved scope.
Artera's tests go to urologists and radiation oncologists weighing treatment after a prostate biopsy result, and to breast oncologists with an early-stage HR+/HER2-negative case. Its two FDA records, DEN240068 and K254115 from May 2026, are prognostic claims. The breast score does not predict treatment benefit.
The overlap is the breast oncologist choosing a recurrence score. Caris sells MI Clarity, an H&E-based score for early HR+/HER2-negative, node-negative breast cancer, yet openFDA's PMA record for Caris is P240010 for MI Cancer Seek and its 510(k) database lists nothing under Caris Life Sciences. For that buyer Caris trails ArteraAI Breast, which carries K254115.
Pathology · Reviewed November 2, 2026
Artera
by Artera
AI risk scores from H&E slides for prostate and breast cancer, run by a CLIA lab. ArteraAI Prostate software is FDA De Novo authorized.
Caris Life Sciences
by Caris Life Sciences · founded 2008
FDA-approved MI Cancer Seek tumor profiling test for oncologists. The GPSai tissue-of-origin AI is a lab service outside that approval.
When to pick each one
Artera
- ArteraAI Breast cleared as K254115
- Prostate and breast prognosis from biopsy slides
Caris Life Sciences
- PMA P240010 for MI Cancer Seek sequencing
- Companion-diagnostic claims include PIK3CA and BRAF V600E
Score
Each row shows points earned of points available under the published rubric.
Artera
65of 100
Caris Life Sciences
65of 100
| Dimension | Artera | Caris Life Sciences | 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 | 21 / 21 | -6.3 |
| 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. |
Caris Life Sciences
| 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)
Caris Life Sciences
FDA decisions
P240010 (opens in new tab)PMA2024-11-05
MI Cancer Seek
Peer-reviewed
5 PubMed records name Caris Life Sciences.
- An AI Approach to Differentiating Lung Squamous Cell Carcinoma From Metastases of Other Origins. (opens in new tab)
- Proactive identification of candidates for newly approved targeted therapies using a clinical decision support program. (opens in new tab)
- ERBB2/HER2 landscape and prognostic impact: large-scale, real-world analysis across solid cancers. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Artera | Caris Life Sciences |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2008 |
| 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.