Tempus Digital Pathology

Who sells it and what changed in 2025?

Tempus AI, Inc. is a Nasdaq-listed company (TEM) in Chicago. It completed the acquisition of Paige on 22 August 2025 for $81.25M, mostly in stock. Tempus's annual report puts the fair value at $101.5M with $141.1M of goodwill, and says the deal brought about 7 million slides. Paige.AI was previously a standalone New York company. Tempus describes the suite as AI-enabled digital pathology solutions meant to "increase diagnostic confidence, improve workflow efficiency, and uncover deeper insights from every sample."

What is actually FDA-authorized?

Paige Prostate Detect was authorized by the FDA under De Novo DEN200080, decided in September 2021. Paige's 510(k)s cover the FullFocus viewer software, K201005 in July 2020 and K241273 in January 2025.

Paige Predict has no FDA authorization or clearance. Tempus labels Predict Tissue Optimization and Biomarker Prediction "RUO", about 1,600 biomarkers across 505 genes, and says it is "not for use in diagnostic procedures." A 123-biomarker version covering 16 cancers is described in coverage from January 2026 as validated as a Tempus laboratory-developed test for xT cases with insufficient tissue. Tempus presents that as a laboratory validation.

What does the product line include?

Per the Tempus page, Prostate Detect finds possible cancer on prostate biopsy slides and carries both FDA authorization and CE-IVDR marking. Tempus claims a 20% shorter reading time. Prostate Grade and Quantify and Perineural Invasion are CE-IVDR and RUO. Breast Detect, Mitosis, Lymph Node, GI and PanCancer Detect are RUO, and the company claims 0.95 specimen-level AUC for PanCancer Detect across more than 40 cancer types.

Prostate Detect must be used with specific scanners and viewers listed on the Tempus page. EHR integration and HIPAA, SOC 2 and HITRUST status are not stated there.

What does the evidence say?

The FDA study from 2021 had 16 pathologists and reported a 7.3% sensitivity gain with the software. A Yale validation of 1,876 slides reported 97.7% sensitivity and 99.3% specificity, according to a secondary summary on PubMed (PMID 42468971). The primary paper was not checked. Coverage of the business is mostly financial, and no user reviews of the software are published.

How much does it cost?

There is no public price. The model is enterprise licensing plus per-test fees for the Tempus lab products.

How does it compare with the other FDA-authorized prostate tool?

Ibex Prostate Detect received FDA 510(k) clearance in early 2025, listed in the FDA 510(k) database as K241232 under the name Galen Second Read, and is the other FDA-authorized prostate tool. Aiforia, PathAI, Proscia and Visiopharm sell other pathology AI. On prostate, Paige and Ibex are the two FDA-authorized options.

The verdict

For prostate biopsy second reads, Paige Prostate Detect is one of two authorized choices, and the scanner compatibility list decides whether it works in your lab. The Yale figures are strong but come from a summary, so a lab should expect its own validation to carry the weight. For everything else in the portfolio the claims are research claims until a clearance appears, and a lab that needs routine breast or GI diagnostic support should buy elsewhere.