Biome Diagnostics
Biome Diagnostics develops an AI-powered microbiome analysis platform that delivers CE-IVD certified predictive diagnostic tests for cancer immunotherapy response and white-label microbiome services to laboratories across 61 countries, while also selling consumer gut-health test kits through its myBioma brand.
- Company typePrivate
- Founded2019
- HeadquartersVienna, Austria
- Headcount11–50
- GTM typeB2B and B2C
- OfferingSoftware
What Biome Diagnostics does
Biome Diagnostics GmbH is a Vienna-based microbiome diagnostics company that operates a dual B2B/B2C model through two integrated brands: myBioma for consumer at-home gut microbiome testing and BiomeDx as the enterprise platform powering white-label microbiome analysis for laboratories, clinics, and research institutions. The company's flagship clinical product, BiomeOne, is the world's first CE-IVD certified stool-based predictive test for cancer immunotherapy (immune checkpoint inhibitor) response, validated in stage III/IV non-small cell lung cancer, renal cell carcinoma, and melanoma patients with 80%+ prediction accuracy. BiomeCRC, a colorectal cancer preventive screening test, is under development with the Medical University of Vienna using over 1,000 probands.
The underlying technology combines DNA sequencing (supporting both 16S and whole-genome sequencing, including Illumina platform integration) with proprietary machine learning algorithms trained on a dataset of 5+ billion microbiome data points. The platform trains 80,000+ AI models annually, maintains a knowledge base of 200,000+ scientific publications, and supports 45+ disease models, with API-enabled white-label report generation for partners. The company holds ISO 13485:2016 and ISO 9001:2015 certifications, GDPR compliance, and is pursuing an FDA clearance pathway.
Revenue is generated through five streams: myBioma consumer test kit sales (one-time and subscription), BiomeOne clinical diagnostic test sales to oncologists and hospitals, white-label/licensing partnerships with laboratories across 61 countries, digital content (e-books, webinars), and dietary supplements. Pricing for clinical tests is not publicly disclosed; consumer subscriptions are recurring with monthly billing and flexible cancellation. The company was founded in 2018, rebranded from myBioma GmbH to Biome Diagnostics GmbH in February 2021, and is led by co-founders Barbara Sladek, PhD, MBA and Nikolaus Gasche, MD, both serving as Managing Directors. Disclosed funding to date consists of a six-digit EUR grant from the Austrian Research Promotion Agency (FFG) in May 2021.
Biome Diagnostics firmographics
Firmographics- Name
- Biome Diagnostics
- Legal name
- Biome Diagnostics GmbH
- Website
- https://biome-dx.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Biome Diagnostics develops an AI-powered microbiome analysis platform that delivers CE-IVD certified predictive diagnostic tests for cancer immunotherapy response and white-label microbiome services to laboratories across 61 countries, while also selling consumer gut-health test kits through its myBioma brand.
- Ownership category
- akta.pro rank
Biome Diagnostics industry classification
Industry- Product category
- Microbiome Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Microbiome Diagnostics & Biomarker Platforms (gut/skin/oral/vaginal) (HLAAAFAH)
- akta.pro secondary industries
- Microbiome Analytics, Sequencing & Bioinformatics Platforms (HLAAAFAI), Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where Biome Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Vienna
- HQ country
- Austria
- HQ region
- Europe
Offices1 record
Markets served
Biome Diagnostics business model
Business model- GTM type
- B2B and B2C
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- myBioma Consumer Microbiome Tests: Direct-to-consumer at-home gut microbiome test kits sold through mybioma.com online shop. One-time purchase model with optional subscription for recurring analysis.
- myBioma Subscriptions: Recurring subscription orders for selected products including test kits, delivered at regular intervals. Payment collected per delivery cycle with storage of payment data for recurring charges.
- BiomeOne Clinical Diagnostic Tests: CE-IVD certified predictive diagnostic test for cancer immunotherapy response sold to healthcare providers and oncologists. Ordered through the BiomeDx platform for medical institutions.
- Digital Content and Supplements: Sale of digital content including e-books and webinars related to gut health. Dietary supplements available individually or as part of subscription packages.
- White-Label/Laboratory Partnerships: B2B partnerships with laboratories providing white-labeled microbiome analysis services using the BiomeDx platform and technology.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | myBioma Consumer Test Kits |
| Subscription | Monthly | myBioma Subscriptions |
| One time/ perpetual license | Pay-as-you-go | BiomeOne Clinical Test Kit |
Go-to-market motion3 records
Distribution channels5 records
Marketing channels8 records
Biome Diagnostics product offering
Product offeringCore offering
Biome Diagnostics develops AI-powered microbiome analysis products combining DNA sequencing with proprietary machine learning models trained on 5+ billion data points. Its clinical flagship BiomeOne is a CE-IVD certified stool-based predictive test that forecasts response to cancer immunotherapy (immune checkpoint inhibitors) for NSCLC, renal cell carcinoma, and melanoma with 80%+ accuracy. The company also sells the myBioma at-home gut health test directly to consumers and licenses the underlying BiomeDx platform to laboratories and clinics via white-label and API integrations.
Product overview
Biome Diagnostics operates as a multi-product company with a unified AI-powered microbiome platform at its core. The portfolio includes myBioma (consumer wellness product for at-home gut health testing), BiomeOne (CE-IVD certified medical device for oncology predicting cancer immunotherapy response), and BiomeCRC (colorectal cancer screening product). All products leverage the BiomeDx Platform which combines DNA sequencing with machine learning, processing data from one of the world's largest standardized microbiome datasets (5+ billion data points) to generate predictive health insights. The company serves both end-consumers and B2B partners including laboratories, clinics, and research institutions.
Differentiator
Problem solved
Functional benefit
Brands
- BiomeDx Platform: AI-powered microbiome platform for B2B partners including laboratories, clinics, and research institutions. Provides white-label reports, API integration, and supports 16S and whole-genome sequencing data.
- BiomeOne
- BiomeCRC
- myBioma
Products and services
- BiomeDx Platform
Quantifiable outcome
- 80%+ prediction accuracy for immunotherapy response
- +2 more outcomes
Companies that use Biome Diagnostics
Customer profileNamed customers11 records
Segments5 records
Ideal customer profiles4 records
Biome Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability4 records
Feature6 records
Biome Diagnostics partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- NM Genomixcore7-year white-label partnership with Bulgarian laboratory NM Genomix for microbiome testing services on the Bulgarian market. NM Genomix offers BiomeDx-powered tests under their own brand with excellent customer satisfaction.
- Klinik FloridsdorfcorePrincipal investigation site for BiomeOne clinical validation study. Department of Internal Medicine and Pneumology led by Prim. Doz. Dr. Arschang Valipour. Major Austrian cancer center participating in multi-center clinical research.
- Medical University of ViennacoreClinical study partner for BiomeOne validation. Ao.Univ.Prof.in Dr.in med.univ. Manuela Schmidinger from Department of Urology involved in research collaboration.
- Medical University of GrazcoreClinical study partner with two departments involved: University Clinic for Dermatology (Univ.Prof. Priv.-Doz. Dr.med.univ. Erika Richtig) and Department of Oncology (Priv.-Doz. Dr.med.univ. Gudrun Absenger and Assoz. Prof. Priv.-Doz. Dr.med.univ. Martin Pichler).
- Medical University of InnsbruckcoreClinical study partner for BiomeOne validation. Univ.-Prof.in Dr.in Van Anh Nguyen from University Clinic for Dermatology involved in research collaboration.
- SanusXminorStrategic partnership announced June 2023 for collaborative development and market expansion in oncology diagnostics.
- St. Pölten University of Applied SciencesminorPartner institution for FFG Data Science Bootcamp. Bioinformatician Christian Jansen participated in bootcamp at the university, conducting microbiome analyses and machine learning model development.
Scale indicators8 records
Recent moves7 records
Expansion highlights6 records
Biome Diagnostics competitors and assessment
Company assessmentDirect peers
- DayTwo: DayTwo sells AI-driven personalized nutrition recommendations based on gut microbiome analysis, with both an enterprise/B2B offering (DayTwo for Healthcare and Health Plans) and consumer/DTC reach. This mirrors Biome Diagnostics' dual B2B + B2C microbiome model.
- CosmosID: CosmosID provides microbiome identification and analytics using next-generation sequencing and a curated reference database, with B2B services for clinical and research customers. It is directly comparable to the BiomeDx sequencing + bioinformatics platform layer.
- Viome Life Sciences: Viome sells direct-to-consumer and enterprise gut microbiome testing using RNA sequencing plus AI-driven recommendations. Comparable to the myBioma consumer product and BiomeDx platform approach.
- Microba: Microba is an Australian microbiome company offering gut microbiome analysis for both consumers (Microba Insight) and clinicians/researchers (Microba Life Sciences), with a B2B platform and clinical partnerships. It is the closest peer to BiomeDx in combining AI-driven analytics with B2B/B2C commercialization of microbiome diagnostics.
Emerging players
- MaaT Pharma: MaaT Pharma is a clinical-stage microbiome company developing therapeutics for oncology (e.g., GvHD) using standardized donor-derived microbiomes. It overlaps Biome Diagnostics on microbiome-oncology but operates in therapeutics rather than diagnostics.
- Seres Therapeutics: Seres is a clinical-stage microbiome therapeutics company with oncology-adjacent programs and a pioneering role in microbiome drug development. Comparable on microbiome science applied to serious disease, with a therapeutic (not diagnostic) model.
- 4D pharma: 4D pharma develops live biotherapeutic products for cancer and respiratory disease using microbiome biology. Adjacent to Biome Diagnostics' focus on microbiome-oncology, but operates in therapeutics rather than diagnostics.
- Vedanta Biosciences: Vedanta is developing defined bacterial consortia as microbiome immunotherapies, with programs in oncology and infectious disease. Adjacent to Biome Diagnostics in microbiome-oncology, but therapeutic rather than diagnostic.
Others
- Zymo Research: Zymo Research supplies microbiome sample collection, DNA extraction, and analysis tools used by labs running their own sequencing. Comparable to Biome Diagnostics at the workflow layer, but as a tooling/infrastructure supplier rather than a clinical-test seller.
Broad incumbents
- Thorne HealthTech: Thorne is an established supplements and diagnostics brand that includes microbiome testing as part of a broader portfolio, with strong consumer and practitioner distribution. It competes with myBioma in DTC microbiome and broader wellness, but with a much wider product set and brand reach.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Biome Diagnostics social profiles
Digital presenceBiome Diagnostics compliance and trust
Trust signalCompliance5 records
Biome Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biome Diagnostics leadership team
Management profileNumber of profiles
Profiles2 records
Biome Diagnostics funding detail
Funding detailFunding overview
Funding rounds2 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biome Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Biome Diagnostics
What does Biome Diagnostics do?
Biome Diagnostics develops AI-powered microbiome analysis products combining DNA sequencing with proprietary machine learning models trained on 5+ billion data points. Its clinical flagship BiomeOne is a CE-IVD certified stool-based predictive test that forecasts response to cancer immunotherapy (immune checkpoint inhibitors) for NSCLC, renal cell carcinoma, and melanoma with 80%+ accuracy. The company also sells the myBioma at-home gut health test directly to consumers and licenses the underlying BiomeDx platform to laboratories and clinics via white-label and API integrations.
Is Biome Diagnostics a public or private company?
Biome Diagnostics is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Biome Diagnostics founded?
Biome Diagnostics was founded in 2019. It employs 11 to 50 people.
Where is Biome Diagnostics based?
Biome Diagnostics is headquartered in Vienna, Austria, in the Europe region.
How does Biome Diagnostics make money?
Five revenue lines are on record. myBioma Consumer Microbiome Tests are the primary driver. The others are myBioma Subscriptions, biomeOne Clinical Diagnostic Tests, digital Content and Supplements and white-Label/Laboratory Partnerships.
Who are Biome Diagnostics's main competitors?
Direct peers on record are DayTwo, CosmosID, Viome Life Sciences and Microba. Emerging players are MaaT Pharma, Seres Therapeutics, 4D pharma and Vedanta Biosciences. Zymo Research is listed as an others. Thorne HealthTech is listed as a broad incumbent.
Does Biome Diagnostics have an API?
Yes. The BiomeDx Platform supports API integration with lab workflows and enables white-label report customization via API, including language, layout, and content customization. The platform integrates with Illumina lab equipment and supports both 16S and whole-genome sequencing data. Developer documentation is at No Information.
What industry is Biome Diagnostics in?
Biome Diagnostics's product category is Microbiome Diagnostics. Its primary akta.pro industry code is HLAAAFAH, Microbiome Diagnostics & Biomarker Platforms (gut/skin/oral/vaginal), with a secondary code of HLAAAFAI, Microbiome Analytics, Sequencing & Bioinformatics Platforms. Its NAICS code is 325413 and its SIC code is 2835.