Primaa
Primaa is a French MedTech platform that applies deep learning to digitised histology slides, helping pathologists detect and quantify breast and skin cancer biomarkers. Its CE-IVDR marked Cleo Breast and Cleo Skin solutions prioritise cases and speed up reporting.
What is Primaa?
Primaa is a French MedTech company, founded in 2018 and based in Orsay, that develops an AI platform for automated cancer diagnosis in histopathology. Its technology combines image analysis and deep learning applied to whole-slide images — digitised histological tissue slides — and is sold under the Cleo product range, which currently comprises two organ-specific solutions, both carrying CE-IVDR marking.
Cleo Breast is an all-in-one primary diagnostic aid for breast tissue. It detects invasive and in situ carcinoma and displays the regions as a heatmap, identifies mitoses and mitotic hotspots with automatic counting, flags potential calcifications, and detects metastases on lymph node slides. A regulatory nuance matters here: macrometastases are CE marked, while micrometastases explicitly are not. Cleo Breast also measures tumour dimensions at any point on the slide.
Cleo Skin, presented by the company as the world's first CE-IVDR marked AI solution for dermatopathology, detects and classifies lesions as melanoma, naevus, squamous cell carcinoma or basal cell carcinoma, measures lesion dimensions and margins automatically, and detects mitoses within melanoma regions.
Both solutions share the same operating model. They act as a first-read tool: the algorithm analyses the slide, prioritises the most critical cases in a smart work list, and the pathologist then reviews the output. Primaa describes the platform as vendor-agnostic and interoperable, integrated into the laboratory workflow and with laboratory machines, and reachable through partner digital pathology platforms including PathPresenter, Proscia, PathAI and Gestalt PathFlow.
The regulatory framing is explicit and important: Cleo is an aid to diagnosis, and its results must be reviewed by accredited doctors. On data, the vendor states that Cleo collects no personal data and that all data stay within the customer's own network. Reported adoption includes more than ten laboratories and clinics in clinical routine and more than forty-five users, with published work covering mitosis detection, multi-centre carcinoma detection and measured reading-time savings.
What it does
- Detect invasive and in situ carcinoma on breast whole-slide images
- Classify skin lesions as melanoma, naevus, squamous cell or basal cell carcinoma
- Detect and automatically count mitoses, including mitotic hotspots
- Prioritise the most critical cases through a smart work list
- Measure tumour dimensions and surgical margins automatically
- Detect calcifications and lymph node macrometastases
- Display detected regions as heatmaps for faster visual review
When to use Primaa / When not to
A quick filter to help you decide if Primaa is the right fit.
When to use Primaa
- Pathology laboratories that have already moved to a fully digital whole-slide imaging workflow
- Pathologists reporting breast cancer cases in day-to-day clinical routine
- Dermatopathologists assessing melanoma, basal cell carcinoma and squamous cell carcinoma
- Laboratory managers who need intelligent triage and case prioritisation to shorten turnaround times
- Digital pathology teams already running PathPresenter, Proscia, PathAI or Gestalt PathFlow
When not to use Primaa
- Clinicians expecting an autonomous diagnosis, since every result must be reviewed by an accredited doctor
- Laboratories that have not digitised their slides, as whole-slide images are the only accepted input
- Teams working on organs other than breast and skin, which the current range does not cover
- Buyers who need a published price list or self-service sign-up, as everything goes through a sales demo
- Anyone relying on micrometastasis detection, which the vendor places explicitly outside its CE marking
How to use Primaa
A typical end-to-end flow, from setup to results.
- Confirm your laboratory digitises slides, since whole-slide images are the only input the platform accepts
- Request a demonstration through the form on the Primaa website, the single commercial entry point
- Scope with Primaa which solution applies: Cleo Breast for breast tissue, Cleo Skin for dermatopathology
- Agree the deployment so that data stays within your own network, as the vendor describes
- Connect the solution to your existing laboratory workflow and laboratory machines
- Access it through your digital pathology platform if you already run PathPresenter, Proscia, PathAI or Gestalt PathFlow
- Let the algorithm perform the first read and populate the smart work list
- Work through the prioritised case list, starting with the cases flagged as most critical
- Review the heatmaps, mitosis counts, measurements and margins produced for each slide
- Validate every result yourself, as the output is an aid to diagnosis requiring accredited medical review
Pros & Cons
Pros
- Two CE-IVDR marked solutions, Cleo Skin being presented as a world first in dermatopathology
- Peer-reviewed evidence, including a PLOS Digital Health publication and further papers in 2024 and 2025
- Published reading-time savings of 14% for invasive and in situ carcinoma, 50% for mitoses and 32% for macrometastases
- Data stays within the customer's own network, with no personal data collection claimed
- Documented integrations with four established digital pathology platforms
- Real clinical adoption at named institutions including AP-HP, Institut Curie, CHU Rennes and CHU Grenoble Alpes
- Named, attributable testimonials from hospital pathologists rather than anonymous quotes
Cons
- No public pricing whatsoever: no rate card, no plan and no free trial, so every purchase runs through sales
- Coverage limited to two organs, breast and skin, with the multi-organ roadmap still announced rather than shipped
- Micrometastasis detection sits explicitly outside the CE marking, unlike macrometastases
- The privacy page exists but contains no policy text at all, leaving GDPR detail confined to the terms
- No data processing agreement, no subprocessor list and no published stance on model training
- A blanket 'Research Use Only' footer sits awkwardly beside the CE-IVDR claims made on the product pages
- The footer address in Paris differs from the registered office recorded at the companies registry in Orsay
Pricing & Plans
Primaa publishes no pricing of any kind. There is no pricing page, no plan, no rate card and no figure anywhere on the site, and neither a free plan nor a free trial is mentioned. The product is sold under contract, the single commercial entry point being the 'Request a demo' form, which makes this a contact-sales model. Prospective buyers should expect a quotation scoped to their laboratory rather than a published subscription price.
Data, GDPR & hosting
A consolidated view of how Primaa handles your data.
GDPR overview
GDPR is addressed explicitly but briefly, and entirely inside the terms and conditions rather than in a dedicated policy. Primaa states that personal information is collected and processed in compliance with Regulation 2016/679, and cites the French Data Protection Act of 6 January 1978. A Data Protection Officer is named: co-founder Stéphane Sockeel. Access, rectification, erasure and objection rights are exercised by writing to contact@primaalab.com, and marketing data is kept for three years. On the product side, the vendor states that Cleo collects no personal data and that all data stay within the customer's network. Notably absent are any data processing agreement, subprocessor list or transfer clause, and the /confidentialite/ page carries no policy text.
Who owns the data?
Primaa's published terms govern the primaalab.com website only, not the software itself, so no contractual clause states who owns the slide data processed by Cleo. What the product pages do say is that Cleo collects no personal data and that all data stay within the customer's own network, which leaves custody of clinical material with the laboratory. For website data, Primaa acts as the controller: it gathers non-personal browsing data plus personal data supplied through the contact, demo and newsletter forms, and grants the French statutory rights of access, rectification, erasure and objection on request by email.
Reuse rights
The terms grant the end user no reuse rights over Primaa's own material. Trademarks, logos, signs and all site content are protected by the French Intellectual Property Code, the Primaa brand is a registered trademark, and any reproduction, publication or copy requires prior authorisation. Use is limited to a strictly private context, and any commercial or advertising exploitation is expressly forbidden; anyone republishing protected content must cite the author and the source. In the opposite direction, the vendor states that Cleo collects no personal data and that all data remain inside the customer's network, so laboratory data is not presented as something Primaa reuses. No data processing agreement sets out these boundaries contractually.
Data retention & training
Hosting summary
Primaa declares no hosting country and no hosting region for the platform. What it does state, on both product pages, is that Cleo collects no personal data and that all data stay within the customer's own network — a deployment posture in which clinical material never leaves the laboratory's infrastructure, so there is no vendor-side jurisdiction to declare. That claim is the vendor's own and is not backed on the site by a hosting annex, a data processing agreement or a subprocessor list. One distinction is worth keeping clear: the primaalab.com marketing site is served from French infrastructure, but that concerns the website only and says nothing about where the diagnostic platform runs. The company itself is established in France and applies French law, so any processing it does perform on its own account falls under French and EU jurisdiction. Laboratories with formal hosting requirements, including health-data hosting obligations, will need to obtain those commitments contractually.
Things to keep in mind
Risks and trade-offs to weigh before adopting Primaa.
- Automation bias is the central clinical risk: a confident heatmap can anchor a pathologist's judgement, and the vendor's own instruction that results must be reviewed by accredited doctors only works if that review stays genuinely independent
- Deskilling over time, particularly for trainees who may learn to confirm the algorithm's mitosis counts and margins rather than to establish them unaided
- The smart work list reorders clinical priorities, so a case wrongly ranked as low-risk may simply wait longer before a human ever looks at it
- Micrometastases fall outside the CE marking while macrometastases do not, a distinction easy to lose in daily use and consequential for staging
- The absence of any data processing agreement, subprocessor list or published training policy leaves patient-data governance to be negotiated privately rather than verified publicly
- The 'Research Use Only' footer contradicts the CE-IVDR claims on the product pages, and using the wrong reading of that notice has regulatory consequences either way
- Published time savings were measured in specific studies and settings, and should not be assumed to transfer unchanged to a different laboratory, scanner or case mix
Setup & Integrations
Technical difficulty
Non-trivial, and institutional rather than individual. There is no self-service sign-up: deployment is scoped through a sales demonstration, then installed into the laboratory environment and connected to existing laboratory machines. Slide digitisation is a hard prerequisite. The effort is lighter for laboratories already running PathPresenter, Proscia, PathAI or Gestalt PathFlow, where Cleo reaches users through a platform already in place. Primaa describes the solution as vendor-agnostic and interoperable, but publishes no technical documentation and no API, so integration planning depends entirely on direct vendor support.
Integrations
Behind Primaa
Fundraising
Social
Resources
All the official URLs gathered for verification and reference.
Frequently asked questions
What does Primaa actually do?
Which solutions does the Cleo range include?
Which biomarkers does Cleo Breast detect?
Which lesions does Cleo Skin cover?
Does it replace the pathologist?
Where does my data go?
How much does it cost?
Is there an API?
Which platforms does it integrate with?
What scientific evidence supports it?
Should you pick Primaa?
Primaa occupies a narrow, serious niche. This is not a general-purpose AI product but a regulated in vitro diagnostic device aimed at pathologists working on digitised slides, and it should be judged on medical-device criteria rather than software ones. On those criteria it holds up well: both Cleo Breast and Cleo Skin carry CE-IVDR marking, the evidence base is peer-reviewed rather than promotional, reading-time savings are quantified and published, and adoption at named institutions such as AP-HP, Institut Curie and several French university hospitals is documented rather than merely claimed. The data posture is unusually favourable too: the vendor states that no personal data is collected and that everything stays inside the laboratory's own network.
The reservations are mostly documentary and commercial. Pricing is entirely opaque, with no rate card, no plan and no trial, so evaluation necessarily begins with a sales conversation. The product-side legal documentation is thin: the privacy page is empty, there is no data processing agreement, no subprocessor list and no published position on model training — gaps that a hospital procurement team will have to close directly with the vendor. A blanket Research Use Only footer also sits awkwardly beside the CE-IVDR claims made on the product pages, and deserves clarification.
Scope is the other limit. Two organs are covered today, breast and skin, with a multi-organ roadmap announced but not delivered, and micrometastasis detection falls outside the CE marking. For a digital pathology laboratory already reporting breast or skin cases at volume, Primaa is a credible, evidence-backed first-read assistant. For anyone else, it is probably too early or too specialised.
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