Freenome vs Tempus Digital Pathology
The FDA approved Freenome's SimpleScreen CRC as PMA P250029 on July 24, 2026. Freenome's release says its PREEMPT CRC trial enrolled more than 48,000 asymptomatic adults aged 45 to 85 at over 200 sites, and a 2025 JAMA clinical-validation paper on the test has a Freenome-affiliated author. An internal medicine clinic offering colorectal screening is the buyer.
Tempus Digital Pathology runs on slides in a pathology lab with prostate biopsy volume, a setting apart from Freenome's blood-based screening. Paige Prostate Detect received De Novo DEN200080 on September 21, 2021 and is CE-IVDR marked, but it must be used with specific scanners and viewers. The vendor claims a 20% shorter reading time. Paige Breast, Lymph Node, GI and PanCancer Detect are research use only, and Paige Predict carries the same label. Tempus completed its acquisition of Paige on August 22, 2025 at an announced price of $81.25 million, mostly stock.
Pathology · Reviewed November 2, 2026
Freenome
by Freenome · founded 2014
FDA-approved SimpleScreen CRC blood test for colorectal cancer screening in adults 45 and older at average risk.
Tempus Digital Pathology
by Tempus AI
Digital pathology AI from Paige, now part of Tempus: Paige Prostate Detect (FDA De Novo, CE-IVDR) plus research-use suites.
When to pick each one
Freenome
- PMA-approved, P250029, July 2026
- Freenome says PREEMPT CRC enrolled 48,000+ adults
Tempus Digital Pathology
- Paige Prostate Detect, FDA De Novo and CE-IVDR
- Vendor claims 20% shorter reading time
- Research-use suites for breast, lymph node and GI
Score
Each row shows points earned of points available under the published rubric.
Freenome
40of 100
Tempus Digital Pathology
38of 100
| Dimension | Freenome | Tempus Digital Pathology | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| 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 | 0 / 21 | 0 / 21 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 12 / 12 | -3.6 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 0 / 6 | +6 |
Scroll horizontally to see every column.
Pricing
Freenome
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Tempus Digital Pathology
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price on the Tempus pages. |
Evidence
Freenome
FDA decisions
P250029 (opens in new tab)PMA2026-07-24
SimpleScreen CRC
Tempus Digital Pathology
FDA decisions
K241273 (opens in new tab)510(k)2025-01-09
Paige FullFocus
DEN200080 (opens in new tab)De Novo2021-09-21
Paige Prostate Detect
K201005 (opens in new tab)510(k)2020-07-15
Paige FullFocus
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Freenome | Tempus Digital Pathology |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2014 | 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.