GRAIL vs Tempus Digital Pathology
Paige Prostate Detect is the FDA-authorized product in the Tempus line, through De Novo DEN200080 decided on September 21, 2021, and it is also CE-IVDR marked. It must be used with specific scanners and viewers. The Paige FullFocus viewer carries K201005 and K241273. Paige Predict, the biomarker prediction line, is labeled research use on the Tempus page, as are the breast, lymph node and PanCancer Detect products. Tempus completed its purchase of Paige on August 22, 2025 for $81.25M, mostly in stock.
Galleri's record is a pending PMA. It received Breakthrough Device designation in 2018 and the PMA was submitted in full on January 29, 2026. openFDA's PMA records list nothing yet under GRAIL or Galleri.
A lab buying Paige and a clinician prescribing Galleri are different buyers, since Paige finds possible cancer on prostate biopsy slides and Galleri analyses a blood draw.
Pathology · Reviewed November 2, 2026
GRAIL
by GRAIL
Galleri blood test for multi-cancer early detection, sold as a CLIA lab test. Not FDA cleared or approved.
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
GRAIL
- Breakthrough Device designation, 2018
- PMA submitted in full January 2026
Tempus Digital Pathology
- Paige Prostate Detect authorized via De Novo
- CE-IVDR marked for prostate detection
- Paige FullFocus viewer holds two 510(k)s
Score
Each row shows points earned of points available under the published rubric.
GRAIL
28of 100
Tempus Digital Pathology
38of 100
| Dimension | GRAIL | Tempus Digital Pathology | Difference |
|---|---|---|---|
| FDA clearance | 0 / 18 | 18 / 18 | -18 |
| 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 | 8.4 / 21 | 0 / 21 | +8.4 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 0 / 7.8 | +7.8 |
| Funding & adoption signal | 8.4 / 12 | 12 / 12 | -3.6 |
| Pricing transparency | 0 / 5 | 2.5 / 5 | -2.5 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
GRAIL
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Tempus Digital Pathology
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price on the Tempus pages. |
Evidence
GRAIL
FDA decisions
No FDA decision cited in our research as of November 2, 2026.
Peer-reviewed
1 PubMed record names GRAIL.
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 | GRAIL | Tempus Digital Pathology |
|---|---|---|
| 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.