Paige

Computational pathology models are the product. The company sells AI suites for prostate, breast, gastrointestinal and pan cancer pathology that support cancer detection, subtyping and molecular biomarker discovery, a pathologist co-pilot called Alba, and a family of foundation models it names publicly (Virchow, Virchow2, Virchow2G, Virchow2G-Mini and PRISM).

Its authorized product, Paige Prostate (DEN200080), is software that flags the location on a digitized prostate biopsy most likely to contain cancer. The FullFocus viewer and image management layer support the models rather than standing as the offer. There is no non AI version of what is sold.

Positioned to support the pathologist, with the authorized product's limits stated in its labeling. Paige Prostate (DEN200080) flags the single location most likely to contain cancer for further review; its output is not to be used as the primary diagnosis, and the pathologist must complete a standard of care evaluation of the slide, on the Philips Ultra Fast Scanner and the FullFocus viewer. The company describes its suites and the Alba co-pilot as delivering insights so pathologists and oncologists reach diagnoses more efficiently, with the pathologist keeping the decision. What is missing is how the other suites surface confidence, which outputs a pathologist may accept without full review, and what happens after an error.

An oversight structure described for the authorized product with the failure handling missing.

The models are named and some are open, without version and update discipline for the clinical suites. The company names its foundation model family (Virchow, Virchow2, Virchow2G, Virchow2G-Mini and PRISM), open sourced Virchow and PRISM in August 2024, and describes the training corpus as millions of slides from more than a thousand institutions through the Memorial Sloan Kettering relationship. The authorized Paige Prostate flags a single location on a prostate biopsy image and runs on a specified scanner and viewer. What is not published is which foundation model version each clinical suite runs on, performance figures for the suites, or how and when their models change.

The approach and models named without version discipline for what is sold.

The model layer is the company's own and the host is known. Paige builds its own foundation models and suites, so no outside model provider sits in the path, and its infrastructure is Microsoft Azure, as Tempus's assumption of Paige's outstanding Azure commitment in the August 2025 acquisition shows. Since then Tempus owns the company, and the privacy policy's clause that personal data transfers with an acquisition has operated. What is not published is a subprocessor list, the parties that receive processed slides, or whether slide data moves into Tempus systems for its oncology foundation model work, which was the stated rationale for the acquisition. The privacy policy covers only websites and online services.

A structurally short chain for the models with the host named and the owner's access unstated.

Regulator reviewed performance for the authorized product, and little else is cited on the company's pages. Paige Prostate received De Novo authorization (DEN200080, 21 September 2021) as the first AI based digital pathology product authorized by FDA, on clinical performance evidence FDA reviewed and summarized in its decision summary; the company later received Breakthrough Device designation for a pan cancer detection tool, which expedites review and is not authorization. The current home page cites no study, customer outcome or deployment figure for any suite. The acquisition by Tempus in August 2025 for a reported $81.25 million is a transaction, not evidence of benefit.

Published, regulator reviewed research for the authorized product, short of independent validation in routine use.

The published privacy instrument does not govern clinical material. Paige's privacy policy is scoped to the company's websites and online services, and the personal information it lists is business and website contact data collected through analytics and marketing tools; it does not describe what happens to the whole slide images a laboratory processes through the Paige Platform or Alba. Retention is open ended, kept for as long as a business purpose exists or law requires, and website data is stated to be stored in the United States. The policy names provider customers as primarily responsible for how patient information is used, publishes a data protection officer with postal address and telephone number, and the training corpus is consistently described as stripped of patient identifiers. The policy also says that if the company or substantially all of its assets are acquired, personal data will transfer, which it did when Tempus acquired Paige in August 2025. No statement covers training use of customer slides, retention of processed images, or what Tempus's ownership changes. Safety engineering is not published.

General assurances that do not reach processed slides.

The relationship is described and the regime is never named. Paige's privacy policy states that where a patient is treated by one of its provider customers, those customers are primarily responsible for determining how Paige uses and discloses the personal information, and directs patients with questions about their health information to their own provider, which describes a business associate position in which the covered entity directs the use. HIPAA is not named, no business associate agreement is referenced, offered or described, and the policy itself is scoped to the company's websites and online services, so no privacy document reaches the processed slides. Paige is a New York company whose prostate product is FDA authorized and sold to United States laboratories, and since August 2025 it is owned by Tempus, so which entity signs a business associate agreement now is also open.

A relationship described without a stated status or a service document.

A recognized certification is named, in the least discoverable place. Paige has no security page or trust center, and its footer carries terms and conditions and a privacy policy. Inside the privacy policy the company states that its security measures are evaluated annually by a qualified third party as part of maintaining its ISO 27001 certification, and that any third party receiving personal information must contractually commit to substantially the same level of security. No certificate, scope or expiry is published, no SOC 2 report or HITRUST certification is named, and there is no penetration testing statement, subprocessor list or vulnerability reporting route. Quality certifications reported by outside sources were not confirmed on the company's pages. How Tempus's security program now applies is not stated.

An ISO 27001 certification named without the artifact.

An authorization is identifiable, and the company's site no longer says which of its products it covers. FDA granted De Novo authorization DEN200080 to Paige Prostate (Paige.AI, Inc.) on 21 September 2021, product code QPN under 21 CFR 864.3750, the first authorization for an AI based digital pathology product: software that flags the location on a digitized prostate biopsy image with the highest likelihood of cancer for further review, used with the Philips Ultra Fast Scanner and the Paige FullFocus viewer, adjunctive and not for primary diagnosis. The company later received Breakthrough Device designation for a pan cancer detection tool, which expedites review and is not authorization.

The current home page lists prostate, breast, gastrointestinal and pan cancer suites, the Alba co-pilot and foundation models, and states no regulatory position for any of them; no AI function is called cleared. The company's pages do not say which suite components are authorized, which are CE marked elsewhere, and which are research use only.

The indication is clear; the scope needed to match it to the suites on offer is not.

Openness about the models, and no evaluation of how they behave across groups. In August 2024 the company open sourced its Virchow and PRISM foundation models, and it names the model family publicly, so outside researchers can probe them for failure modes without the company's cooperation. The training corpus is described as millions of slides from more than a thousand institutions through the Memorial Sloan Kettering relationship, characterized in Tempus's acquisition materials as spanning 45 countries and diverse genders, races and ethnicities. Open weights and a described corpus are not a published evaluation: no results by scanner, stain, institution, tissue type or patient group are published for the clinical suites, and no governance framework or process for reviewing model behavior is described.

Openness asserted and enabled, with no evaluation by group.

The authorized product is adjunctive, so a pathologist reviews every slide, and nothing stands behind the output. Paige Prostate (DEN200080, 21 September 2021) flags a single location on the image with the highest likelihood of cancer for further review; its labeling says the output should not be used as the primary diagnosis and must be combined with a complete standard of care evaluation of the slide. That is review before commit, and the flagged coordinates let a pathologist check the basis. The De Novo decision summary is written by FDA, and the company's current home page does not cite the authorization or its study, so its performance figures are not the company's published error rate. The device reporting and correction duties that come with authorization are legal obligations, not a commitment the company makes to a laboratory. No warranty, indemnity or remediation commitment is published, and no error rate is published for the other suites.

Adjunctive review with nothing attached to the output.

Integration inside the pathology stack is claimed, and no system outside it is named. Paige ships its own viewing and case management layer, the FDA cleared FullFocus viewer and the FullFolio image management system, as a turnkey option, and states that its applications also run inside partner digital pathology platforms, so a laboratory that already runs an image management system need not replace it. The home page names no partner platform, laboratory information system, electronic health record or interface standard such as HL7 or FHIR, and Paige Prostate is authorized for use only with the Philips Ultra Fast Scanner and FullFocus, so compatibility for the authorized use is bounded.

Integration claimed with no outside system named.

Two deployment routes are described, and no location for slide data is committed. A laboratory can run the applications inside a partner digital pathology platform it already uses, or adopt the Paige Platform with its own FullFocus viewer and image management, with an onboarding process from integration through training to support. The infrastructure is Microsoft Azure, as Tempus's assumption of Paige's outstanding Azure commitment in the 2025 acquisition shows. The only residency statement published covers website data, placed in the United States; nothing states where slide images are processed or stored, whether regional options exist for laboratories outside the United States, or how the arrangement changes under Tempus.

Hosted routes described with the location of clinical data implied rather than committed.

No pricing is published, and the route to buy is. The suites and the platform carry no list price, tier structure, per slide or per case rate, or subscription level. Evaluation runs through a trial request and commercial terms through contact with the company, and the platform has been distributed through a cloud marketplace, which can carry standard terms. The products are positioned partly on pathologist time saved, which invites a cost comparison that cannot be made without a price. Since Tempus acquired the company in August 2025 and now announces Paige products such as Paige Predict itself, it is not stated which entity contracts and bills, or whether the suites are sold standalone or bundled with Tempus testing.

The sales route can be traced in outline, and the price cannot.

Coverage is named by organ, with validation behind the authorized prostate product. The company sells suites for prostate, breast, gastrointestinal and pan cancer pathology to clinical pathology laboratories, and, through Tempus, reaches precision oncology programs. Paige Prostate's authorization names its setting precisely: digitized prostate biopsy images from the Philips Ultra Fast Scanner, viewed in FullFocus, as an adjunct to the pathologist's review. The breast, gastrointestinal and pan cancer suites are named without validation on the company's pages, and the pan cancer tool holds Breakthrough designation rather than authorization.

Coverage named with validation behind part.