Chat GPT Compares Path AI, Artera, PAIGE
ChatGPT said:
Here’s a comparative sketch of Paige, Artera, and PathAI along the dimensions you asked (plus a few extras). Because some of the information (especially funding, regulatory status) changes over time, treat this as current as of mid-2025.
Paige
Products / Focus
Paige develops AI and digital pathology tools, primarily for cancer diagnosis and biomarker prediction. Its offerings include the Paige Prostate Suite, Paige Breast Suite, and GI / PanCancer AI modules, which support detection, classification, and biomarker prediction from whole-slide images. Paige.ai+3Paige.ai+3Azure Marketplace+3 It also markets FullFocus, a whole-slide image viewer cleared for clinical use, which integrates with AI overlays and third-party algorithms. Paige.ai+2Azure Marketplace+2 Its recent announcements emphasize foundation models (Virchow, Virchow2) for scalable multi-tissue AI. Paige.ai+1
Regulatory Status
Paige has at least one AI application that is FDA cleared (or cleared under De Novo) in pathology. For example, its Paige Prostate Detect is cited as FDA-cleared in some of the company’s materials. Pathology News+4Paige.ai+4Azure Marketplace+4 The FullFocus viewer is also “FDA-cleared” (as a medical device for image viewing). Azure Marketplace+1 However, many of its AI models are still described in “assistive” or adjunctive terms (i.e. supporting pathologists) or for research/biomarker development. aiforia.com+2Paige.ai+2
Venture Capital / Backing
The public disclosures around Paige’s total capital raise are more limited compared to some peers. However, it attracted significant investor attention, especially from health tech and oncology/AI funds. Its acquisition by Tempus in 2025 suggests that prior VC investment was substantial enough to generate value. Business Wire The acquisition press release describes Paige as having developed and deployed “several AI applications, including the first FDA-cleared AI application in pathology.” Business Wire
Location / Corporate Structure
Paige is headquartered in New York (or broadly operates in U.S.), with global reach. Paige.ai+2LinkedIn+2 After the acquisition, it’s now part of Tempus. Business Wire
Artera (ArteraAI)
Products / Focus
Artera focuses on AI-enabled prognostic and predictive tests in oncology, particularly prostate cancer. Its flagship is the ArteraAI Prostate Test, which inputs a digitized pathology slide (plus clinical data) and outputs both prognostic risk metrics (e.g. distant metastasis, cancer-specific mortality) and predictive estimates (e.g. benefit from shorter androgen deprivation therapy). ArteraAI+4ArteraAI+4ArteraAI+4 Artera also mentions plans or versions for breast cancer, and a broader multimodal AI (MMAI) platform combining tissue imaging and clinical features. Fierce Healthcare+4Business Wire+4ArteraAI+4
Regulatory Status
Recently, Artera secured FDA De Novo marketing authorization for its ArteraAI Prostate in the U.S. Morningstar It also has Breakthrough Device Designation from FDA for that same test, which may accelerate review pathways. Mobi Health News Internationally, Artera holds UKCA marks for certain versions of its software (e.g. prostate biopsy assay, breast versions) in the UK. abhi.org.uk+1 That said, in the U.S., Artera historically deployed its test as a CLIA laboratory-developed test (LDT) before full device clearance. ArteraAI+4ArteraAI+4ArteraAI+4
Venture Capital / Backing
Artera is a VC-backed company. Tracxn reports it as a Series A company founded in 2021 out of Menlo Park, California. Tracxn Also, in media interviews, Artera refers to a $90 million investment for scaling, including testing expansion and product development. Mobi Health News+1 It has also formed partnerships (e.g. with Tempus, see below) likely tied to funding and strategic investment. Inside Precision Medicine
Location / Corporate Structure
Artera is based in Los Altos, California (with terms & corporate address in Los Altos) as its corporate headquarters. ArteraAI+3ArteraAI+3Business Wire+3 Its clinical laboratory, where the LDT was run, is in Jacksonville, Florida under CLIA certification. Business Wire
After the Tempus–Paige acquisition, Artera seems to have a partnership or strategic overlap as well: Artera’s tests may integrate with or be deployed in Tempus workflows. Inside Precision Medicine
PathAI
Products / Focus
PathAI builds AI and digital pathology software platforms, primarily for image management, AI model deployment, and algorithm development (especially for research, biomarkers, and clinical trials). Its core platform is AISight / AISight Dx, a cloud-native digital pathology image management and slide viewer system, which integrates AI modules and enables collaboration, case routing, and interoperability. info.pathai.com+6PathAI+6PathAI+6 PathAI also develops numerous AI models for biomarker detection, histologic feature extraction, and predictive analytics, used in both research and, increasingly, in clinical support. Clinical Trial Vanguard+4PathAI+4PathAI+4
Regulatory Status
PathAI’s AISight Dx has FDA 510(k) clearance for use in primary diagnosis (when paired with certain slide scanners) as of June 2025. PathAI+4GlobeNewswire+4Medical Device Network+4 The company also has CE-IVD marking for AISight Dx for diagnostic use in Europe. PathAI+1 The FDA granted a Predetermined Change Control Plan (PCCP) along with the 510(k), meaning that PathAI can make certain defined future changes (e.g. support new scanners or browsers) without a new 510(k) application. GlobeNewswire In earlier years, PathAI had also achieved 510(k) clearance for earlier versions of its software (AISight Dx in 2022) and held both FDA and CE markings then. PathAI+1
Venture Capital / Backing
PathAI has raised multiple funding rounds. The most public is a $165 million round in 2021 led by D1 Capital Partners and Kaiser Permanente, intended to scale its platform and expand toward diagnostics. PathAI+1 Other sources note earlier rounds (seed, Series A/B) cumulatively raising $90+ million as of earlier reporting. Clay PathAI is clearly one of the better capitalized AI-pathology companies.
Location / Corporate Structure
PathAI is headquartered in Boston, Massachusetts. PathAI+2PathAI+2 It operates globally, particularly serving biopharma, academic, and diagnostic labs. PathAI+2Precision For Medicine+2
Comparative Observations & Additional Notes
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Product positioning and business model
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Paige leans toward diagnostic tools (assistive AI) plus imaging infrastructure (viewer + AI modules), positioning itself close to the pathologist workflow.
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Artera is more niche and focused: its value proposition is a prognostic/predictive AI test that supplements standard pathology (i.e., acts atop the slide and clinical data).
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PathAI is more of a platform / backbone infrastructure + algorithm development company; it supports both research/biomarker customers and evolving clinical applications.
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Regulatory maturity
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Artera has achieved De Novo clearance for its core test, giving it a relatively high regulatory bar (and a favorable status).
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PathAI has achieved 510(k) clearance for digital pathology platform use in primary diagnosis, which is a milestone in more general purpose software.
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Paige, while already having FDA-cleared components, is still building its AI model portfolio into cleared, broadly deployed diagnostics.
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Vertical integration vs modularity
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Artera’s model is relatively vertical: the slide comes in, Artera’s lab does the digitization, runs its AI, and returns a report.
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PathAI is more modular and interoperable: its AISight platform integrates third-party algorithms (including Paige) to allow plug-in models. PathAI
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Paige similarly seeks to interoperate: its FullFocus viewer can host third-party AI models. Paige.ai+1
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Strategic consolidation
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The acquisition of Paige by Tempus potentially reshapes competitive alignments; Artera has already announced partnerships with Tempus to expand distribution. Inside Precision Medicine
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PathAI is forging collaborations (e.g. with precision medicine / clinical trial labs) to embed its algorithms deeper into drug development pipelines. Precision For Medicine
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Scale, data, and foundation models
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Paige emphasizes its large datasets (millions of slides) and its foundation model strategy (Virchow) to scale multi-tissue AI. Paige.ai+2Paige.ai+2
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Artera emphasizes clinical trial validation (Phase III trials, long-term follow-up) to support its prognostic model’s legitimacy. ArteraAI+2ArteraAI+2
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PathAI, besides software and algorithm development, is leveraged by biopharma for biomarker and tissue-based analytics, giving it broad access to diverse data modalities. PathAI+3PathAI+3Clinical Trial Vanguard+3
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Risk & barrier profiles
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Artera’s approach is higher risk (a specialized predictive test must prove clinical utility) but potentially higher reward (unique clinical value).
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PathAI is hedged: its platform can generate revenue from many customers, even if individual AI models take longer to mature.
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Paige lies somewhere between: it builds AI models that support pathologists, but must move more of those models into cleared, reimbursable tools.
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If you like, I can prepare a table or infographic summarizing these comparisons for your blog (so your readers can more easily see “who does what”). Would you like me to do that?
You said:
ChatGPT said:
Short answer: Yes, you need a New York State clinical laboratory permit (CLEP) if you’re testing NY specimens—but CLEP does not make you submit digital pathology/AI as an LDT for approval.
Here’s the precise policy: New York states that only laboratories holding a NYS clinical laboratory permit are authorized to perform testing on specimens originating from New York. On the same page, CLEP explicitly says “the use of digital imaging of slides in pathology will not be subject to submission requirements as a laboratory-developed test. This includes digital imaging of slides with subsequent use of artificial intelligence/machine learning.” At the same time, NY requires that a licensed pathologist examine and report all surgical pathology and cytopathology cases, and it notes that digital imaging systems and algorithms may still require FDA approval—that is a separate FDA device issue, not a CLEP LDT filing. wadsworth.org
Two additional, practical NYS points:
• Validation of WSI remains required under the state’s pathology standards (i.e., labs must validate that whole-slide images are complete and suitable for diagnosis). wadsworth.org
• Remote work/sign-out is permitted under conditions set by NYSDOH (e.g., the primary lab must hold the NYS permit; remote personnel are employees of that permitted lab; activities are limited to those appropriate for remote review). These are operational rules tied to the NY permit, not an LDT submission. PIcc Alliance
Bottom line for companies like Paige, Artera, and PathAI (or hospitals using them):
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If you are offering clinical results on NY specimens, you must operate under a NYS clinical laboratory permit in the relevant categories. wadsworth.org
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Digital pathology/AI use itself does not trigger an LDT submission to CLEP, but you still need proper WSI validation, licensed pathologist sign-out, and you should ensure any AI/viewing software has the needed FDA status for its intended diagnostic use. wadsworth.org+1