Freenome vs Indica Labs HALO AI
In the vendor's prespecified, census-adjusted analysis, SimpleScreen CRC showed 81.1% sensitivity for colorectal cancer and 90.4% specificity for advanced colorectal neoplasia. The PREEMPT CRC trial enrolled more than 48,000 asymptomatic average-risk adults aged 45 to 85 at over 200 sites. A 2025 JAMA paper titled "Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer" has a Freenome-affiliated author. SimpleScreen CRC is a test for screening clinics. Abbott holds the U.S. commercial rights, and the approval release does not state the ordering route.
A pathology department picks Indica for HALO AP Dx and primary diagnosis, and a research lab or pharma group takes the HALO AI add-on. Those buyers and a screening clinic do not compete for one purchase.
Leica Biosystems made a strategic investment in Indica in January 2025 and is now the exclusive reseller of Indica's image management products. In a December 2025 release Indica says clinical revenue grew 260%, a self-reported figure.
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.
Indica Labs HALO AI
by Indica Labs
HALO image analysis and AI for pathology research, plus HALO AP Dx (FDA-cleared) and HALO Prostate AI (CE-IVD) for clinical use.
When to pick each one
Freenome
- Vendor-reported 81.1% sensitivity for colorectal cancer
- Vendor-reported 90.4% specificity, advanced neoplasia
- PREEMPT CRC enrolled over 48,000 adults
Indica Labs HALO AI
- Leica Biosystems invested in Indica in January 2025
- HALO AP Dx cleared as K252762 in 2025
- HALO Prostate AI is CE-IVD marked
Score
Each row shows points earned of points available under the published rubric.
Freenome
40of 100
Indica Labs HALO AI
33of 100
| Dimension | Freenome | Indica Labs HALO AI | 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 | 8.4 / 12 | 0 |
| 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. |
Indica Labs HALO AI
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Freenome
FDA decisions
P250029 (opens in new tab)PMA2026-07-24
SimpleScreen CRC
Indica Labs HALO AI
FDA decisions
K252762 (opens in new tab)510(k)2025-11-25
HALO AP Dx
K232833 (opens in new tab)510(k)2024-05-07
HALO AP Dx
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Freenome | Indica Labs HALO AI |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2014 | n/a |
| HQ | US | n/a |
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.