BiomeDx
BiomeDx is an Austrian AI microbiome platform sold to laboratories, clinics and research partners. It turns raw gut sequencing data into predictive, white-labelled preventive health reports, combining trained prediction models with nutrition recommendations and a conversational assistant.
What is BiomeDx?
BiomeDx is an end-to-end artificial intelligence platform for gut microbiome analysis, built by Biome Diagnostics GmbH in Vienna. It is sold to organisations rather than individuals: laboratories, distributors, longevity clinics, pharmaceutical partners and research institutions. The platform takes raw sequencing output and returns a finished, predictive health report, with the vendor claiming results within hours and delivery inside 24 hours on its laboratory plan.
The technology rests on what the company describes as one of the world's largest standardised microbiome datasets: 5 billion data points across more than 50,000 individual samples. Elsewhere the homepage cites over 80,000 samples analysed with health data, 61 active countries and 45+ disease models, so the published figures are not perfectly consistent. Both 16S and whole-genome sequencing are supported, more than 80,000 models are trained per year, and the company says it analyses over 5,000 bacterial species.
Three named components do the work. The BiomeDx Predictor combines 120+ health data points with sequencing data, using neural networks, random forests and gradient boosting, to estimate the likelihood of 18 conditions including colorectal cancer, irritable bowel syndrome, SIBO, psoriasis, acne, thyroid disorders and blood sugar regulation. The BiomeDx Recommender converts those predictions into dietary and lifestyle guidance, checked by certified nutritionists. The BiomeDx Agent, named Mika and launched in December 2025, is a conversational layer trained on 200,000 scientific publications that lets users and clinicians interrogate their results.
Two products sit on top of the platform: myBioma, the publisher's consumer brand, and BiomeOne, a clinical test that predicts response to checkpoint inhibitor cancer immunotherapy and carries a CE-IVD marking with Biome Diagnostics as the manufacturer. The company claims ISO 9001:2015 and ISO 13485:2016 certification and cites more than 13 peer-reviewed publications. Integration is offered through API, sFTP and Illumina BaseSpace, with compatibility claimed for 99% of existing laboratory systems.
What it does
- Turn raw 16S or whole-genome gut sequencing data into a finished health report
- Predict the likelihood of 18 clinically relevant conditions from a stool sample
- Generate personalised nutrition and lifestyle recommendations from microbiome and questionnaire data
- Answer follow-up questions through Mika, a conversational assistant trained on scientific literature
- Connect to laboratory sequencers through API, sFTP or Illumina BaseSpace
- Deliver fully white-labelled reports customised in language, layout and content
- Predict response and adverse events for checkpoint inhibitor immunotherapy via BiomeOne
When to use BiomeDx / When not to
A quick filter to help you decide if BiomeDx is the right fit.
When to use BiomeDx
- Diagnostic laboratories that already sequence in-house and want analysis and reporting delivered as software
- Distributors and wellness brands seeking a turnkey microbiome test without building lab facilities
- Longevity and preventive medicine centres adding gut insights to client health programmes
- University and research institutions needing curated, anonymised microbiome datasets for studies
- Oncologists using BiomeOne to inform checkpoint inhibitor immunotherapy decisions
When not to use BiomeDx
- Individuals looking to buy a single gut test for themselves, which is the sister brand myBioma's remit
- Buyers who need public pricing before making contact, since every plan routes to a sales conversation
- Anyone expecting a medical diagnosis, which the vendor explicitly says its analysis does not provide
- Developers wanting to self-serve against an open API, as the documentation sits behind authentication
- Organisations requiring a published privacy policy or DPA before procurement, as neither exists on the site
How to use BiomeDx
A typical end-to-end flow, from setup to results.
- Identify which engagement model fits: software only, end-to-end, or white-label
- Contact the team through the site's contact form, as there is no self-service sign-up
- Agree commercial terms, including any territory exclusivity, directly with the vendor
- Connect your sequencer or data source via API, sFTP or Illumina BaseSpace
- Let the pipeline run quality control on each sequencing read before analysis
- Have taxonomic and functional analysis produce the standardised dataset
- Review the Predictor output across the covered clinical conditions
- Configure report design, language and any custom recommendations for white-label delivery
- Deliver reports to your own customers or clinicians under your brand
- Use the Mika assistant and the help centre for follow-up questions on results
Pros & Cons
Pros
- One of the largest standardised microbiome datasets claimed in the sector, at 5 billion data points
- Scientific validation is published, with more than 13 peer-reviewed papers in recognised journals
- BiomeOne carries a CE-IVD marking with the publisher named as manufacturer in its instructions for use
- ISO 9001:2015 and ISO 13485:2016 certification is claimed consistently, with a dated surveillance audit
- Broad technical integration, with compatibility claimed for 99% of laboratory systems
- Corporate identity is fully verifiable against the Austrian commercial register and VIES
- Nutrition recommendations are reviewed by certified nutritionists rather than generated unchecked
Cons
- No pricing is published anywhere; all three partnership models route to a contact form
- No privacy policy exists on the domain, as /privacy simply redirects to the legal notice
- The terms served are largely those of the consumer shop myBioma, not the B2B platform
- API documentation is not public, with the documentation endpoint returning an authentication error
- ISO certifications are claimed without a certificate number or a named certification body
- BiomeOne is declared under the older IVD Directive 98/79/EC rather than the IVDR
- Sample counts differ between the homepage meta description and the page body
Pricing & Plans
No pricing is published for BiomeDx. The three partnership models — software only, end-to-end and white-label — each end with an invitation to get in touch rather than a figure, there is no pricing page, and none appears in the sitemap. Pricing is evidently negotiated per contract according to model and volume. No permanent free plan and no free trial are mentioned or denied. The only monetary amount on the site is a EUR 20.00 deduction applied when a consumer withdraws after a myBioma test kit has shipped, which is a cancellation charge under the sister brand's terms and not a price for this platform.
- direct sequencer integration
- new runs retrieved every 3 hours
- BiomeDx software analysis
- personalised recommendations
- results delivered within 24 hours — price on request
- sampling kits
- transportation
- next-generation sequencing
- BiomeDx software analysis
- personalised recommendations — price on request
- custom report design
- API and webhook integration
- multiple languages
- custom recommendations — price on request
Data, GDPR & hosting
A consolidated view of how BiomeDx handles your data.
GDPR overview
Biome Diagnostics GmbH is established in Vienna, so the GDPR applies, and the terms confirm Austrian law with Vienna as the place of jurisdiction. Beyond that, concrete GDPR material is absent. There is no privacy policy on the domain: /privacy returns a redirect to the legal notice, and no privacy page appears in the sitemap. No data protection officer is named, no Article 27 representative is designated, no retention period is published, no DPA is offered and no subprocessor list exists. The only data-related passage in the legal notice is a short paragraph about cookies. The site never claims GDPR compliance in so many words, and never denies it either, so the compliance flag has been left empty rather than marked negative.
Who owns the data?
The site does not answer this clearly. BiomeDx publishes no privacy policy at all: the /privacy path redirects to the legal notice, and the sitemap contains no privacy page. The only terms available are those of the publisher's consumer shop, myBioma, which reference a privacy policy hosted elsewhere and give service@mybioma.com as the contact. Those terms state that results and personal data sit in a user profile, that samples are analysed in anonymised form through an ID only, and that the partner laboratory is contractually bound to data protection rules. Who owns data under a B2B partner contract, and what BiomeDx may do with it, is never set out publicly.
Reuse rights
No public document grants or restricts reuse rights for partners. The consumer terms cover ordering, delivery and withdrawal rather than data licensing, and they state that all trademarks, graphics and texts are the intellectual property of Biome Diagnostics GmbH. Users may request deletion of their profile and data at any time, subject to legal retention obligations. Separately, the technology page says prediction models are continuously retrained on the company's growing dataset, and that research partners may access curated, anonymised datasets. Whether customer or patient data feeds that dataset, and on what terms, is not stated anywhere on the site.
Data retention & training
Hosting summary
Nothing is published. The site names no hosting country, no region and no cloud provider, and there is no privacy policy, trust page or security page where such a statement would normally appear. The only related wording is in the BiomeOne instructions for use, which describe the product as cloud-based in vitro diagnostic software able to store, transfer and analyse sequencing files, without saying where that cloud sits. The publisher is established in Vienna and its terms specify Austrian law and Vienna jurisdiction, which indicates the governing law but not the location of the data. Prospective partners should request the hosting jurisdiction in writing, since it cannot be established from public sources.
Things to keep in mind
Risks and trade-offs to weigh before adopting BiomeDx.
- The terms served on this site are largely those of the publisher's consumer shop myBioma, so any contractual fact drawn from them may not govern a B2B partnership
- No privacy policy is published on the domain, leaving retention, hosting and data rights undocumented for a product that processes health data
- ISO 9001 and ISO 13485 are claimed on four pages without a certificate number or a named certifying body, so the claims cannot be independently checked
- BiomeOne is declared under Directive 98/79/EC, the older IVD regime, rather than the current IVDR 2017/746
- Published sample counts are inconsistent, with the homepage meta description citing 50,000+ and the page body more than 80,000
- Predictive health scores invite over-reading: the vendor itself insists results support a clinician's decision and never replace it
- The sample report circulated on the site contains demonstration data, including a fictitious patient and physician, which should not be mistaken for real performance evidence
Setup & Integrations
Technical difficulty
Technically light, commercially heavy. The vendor offers several connection routes — API, sFTP, Illumina BaseSpace and other sequencer connectors — and claims compatibility with 99% of existing laboratory systems with instant onboarding and no technical overhead. For a lab already running sequencing, the integration work is modest. The real effort lies upstream: there is no self-service sign-up, so access begins with a negotiated partnership, and white-label deployments add report design, language and custom recommendation work before anything goes live.
Deployment
Integrations
Supported languages
Behind BiomeDx
Social
Resources
All the official URLs gathered for verification and reference.
Frequently asked questions
What does BiomeDx actually sell?
How much does it cost?
How many samples can the platform handle?
Which countries does BiomeDx serve?
Is there an API?
What certifications does BiomeDx hold?
Can reports and kits be customised?
Does BiomeDx provide a medical diagnosis?
Is there a mobile app?
Is there a minimum age?
Should you pick BiomeDx?
BiomeDx is a credible, narrowly targeted platform rather than a general-purpose AI tool. Its strengths are unusually verifiable: the publisher's legal identity checks out against the Austrian commercial register and the EU VAT system, its BiomeOne test carries a CE-IVD marking with the company named as manufacturer, and its scientific claims rest on more than a dozen peer-reviewed publications. For a laboratory or a distributor wanting to add microbiome analytics without building the bioinformatics themselves, the integration story is genuinely strong.
The reservations are commercial and documentary rather than scientific. Nothing about pricing is public, so any evaluation begins with a sales conversation and no budget can be estimated in advance. More awkwardly for a company handling health data, the site carries no privacy policy at all — the privacy path simply redirects to the legal notice — and the terms it does serve are largely those of the publisher's consumer shop, myBioma, right down to a different contact address. Any contractual fact drawn from them is therefore revocable for the B2B platform. The ISO certifications are asserted consistently across four pages and backed by a dated surveillance audit, but no certificate number or certifying body is given, and BiomeOne is declared under the older IVD Directive rather than the current IVDR.
The result is a tool worth shortlisting on capability and provenance, and worth interrogating hard on contract terms. Prospective partners should ask directly for the privacy policy, the data processing agreement, the hosting jurisdiction and the certificate references, none of which the website supplies.
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