# Microbiome diagnostic panels
Stool- or swab-based sequencing panels that profile the gut or GI microbiome for consumer wellness insight or clinical pathogen/dysbiosis detection, distinct from general human genomics services: Viome (US, consumer wellness) and Codex Genetics (US, clinical metagenomics), Sequentia Biotech's IVDR-CE-marked MICK Clinical in Spain, Realbio Genomics in China, and Yaazh Xenomics in India.
Source: https://en.bioecon.ru/technology/microbiome-diagnostic-panels/
Updated: 2026-08-18
## Overview and value chain
Markers: [EC: IVDR 2017/746 | OECD: Biotech-health | Regulator: FDA (USA), EMA (European Union), NMPA (China)]
Microbiome diagnostic panels sequence and analyze the gut or gastrointestinal microbiome from a stool or swab sample, spanning consumer wellness testing at one end and clinical pathogen/dysbiosis diagnostics at the other. Viome offers an AI-powered "Full Body Intelligence" test that analyzes gut microbiome RNA expression to generate personalized health, aging and dietary insights for consumers. Codex Genetics runs a clinical metagenomic whole-genome-sequencing (WGS) platform with dedicated gastroenterological, gastric and metabolic diagnostic panels. Sequentia Biotech, based in Barcelona, Spain, recently achieved CE-IVD marking under the EU's In Vitro Diagnostic Regulation (IVDR) for MICK Clinical, its bioinformatics software solution for gastrointestinal-pathogen detection — a real regulatory milestone for a clinically actionable microbiome diagnostic. In China, Realbio Genomics offers microbiome health-testing services as part of the country's growing microbiome-testing base. In India, Yaazh Xenomics provides gut microbiome testing alongside broader microbial identification, metagenomics-analysis and bioinformatics services.
The key directions of microbiome diagnostic panels are:
1. **Consumer wellness microbiome testing (Consumer Microbiome Testing):** direct-to-consumer gut microbiome tests generating personalized health, nutrition and aging insights rather than a clinical diagnosis — Viome.
2. **Clinical metagenomic diagnostic panels (Clinical Metagenomic Panels):** dedicated gastroenterological, gastric and metabolic metagenomic sequencing panels used in clinical diagnostic workflows — Codex Genetics.
3. **Bioinformatics-driven GI pathogen detection (Bioinformatics GI Diagnostics):** regulatory-cleared software analyzing microbiome sequencing data to detect gastrointestinal pathogens for clinical use — Sequentia Biotech's MICK Clinical.
4. **Regional microbiome testing services (Regional Microbiome Testing):** domestic microbiome sequencing and testing services adapted to a local market and regulatory pathway — Realbio Genomics, Yaazh Xenomics.
### Sectoral value chain
```
[sample collection (stool/swab)] ──> [sequencing/metagenomic profiling] ──> [bioinformatics taxonomic/functional analysis]
│
(report generation: health or diagnostic)
│
▼
[clinical or consumer action] <─── [regulatory clearance (where clinical)] <─────┘
```
### Value chain levels
| Level | Description | Key inputs/outputs |
|:---|:---|:---|
| **Sample Collection** | a stool or swab sample collected by the consumer/patient, typically shipped to a central lab | **In:** consumer/patient sample kit.
**Out:** collected biological sample. |
| **Sequencing & Metagenomic Profiling** | shotgun metagenomic or targeted sequencing of the microbial DNA/RNA present in the sample | **In:** biological sample.
**Out:** raw metagenomic sequence data. |
| **Bioinformatics Analysis** | taxonomic classification and functional-pathway analysis of the microbial community | **In:** raw sequence data.
**Out:** microbiome composition/functional profile. |
| **Report Generation** | a consumer wellness report or clinical diagnostic report is generated from the analysis | **In:** microbiome profile.
**Out:** health insight report or diagnostic result. |
| **Regulatory Clearance** | clinical-use panels require FDA LDT/CLIA status, EU IVDR CE marking, or NMPA approval; consumer wellness tests generally do not | **In:** clinical validation data (clinical panels only).
**Out:** cleared diagnostic (clinical panels) or wellness product. |
| **Clinical/Consumer Action** | a clinician acts on a pathogen/dysbiosis diagnosis, or a consumer adjusts diet/lifestyle based on wellness insights | **In:** report result.
**Out:** treatment decision or lifestyle change. |
Cross-cutting technologies of the sector:
- **Shotgun metagenomic sequencing (Clinical Metagenomic Panels):** untargeted sequencing of all microbial DNA in a sample identifies the full community composition, including pathogens a targeted panel might miss.
- **RNA-based microbiome activity profiling (Consumer Microbiome Testing):** analyzing microbial RNA expression (rather than DNA presence alone) captures which microbial functions are actively occurring, the basis of Viome's health-intelligence scoring.
- **Bioinformatics pathogen-detection software (Bioinformatics GI Diagnostics):** regulatory-cleared analysis software processes microbiome sequencing data to flag clinically actionable gastrointestinal pathogens, as Sequentia Biotech's IVDR-cleared MICK Clinical does.
---
## US
The US spans both ends of the microbiome-testing spectrum, from Viome's consumer wellness platform to Codex Genetics' clinical metagenomic diagnostic panels.
### Viome, Codex Genetics, FDA
- **Viome:** offers an AI-powered "Full Body Intelligence" test analyzing gut microbiome RNA expression to generate personalized health, aging and dietary insights for consumers, marketed as a wellness rather than diagnostic product.
- **Codex Genetics:** runs a clinical metagenomic whole-genome-sequencing platform with dedicated gastroenterological, gastric and metabolic diagnostic panels for clinical use.
- **FDA framework:** clinical microbiome diagnostic panels reach the US market predominantly as laboratory-developed tests (LDTs) under CLIA, while consumer wellness tests like Viome's generally fall outside FDA diagnostic-device regulation as non-diagnostic products.
---
## CN
China hosts a growing domestic microbiome-testing base, with Realbio Genomics among the active providers of microbiome health-testing services.
### Realbio Genomics, NMPA
- **Realbio Genomics:** offers microbiome health-testing services as part of China's growing microbiome-testing base.
- **NMPA framework:** clinical-use microbiome diagnostic panels in China require NMPA approval as in-vitro diagnostic products, while consumer wellness-oriented tests generally face lighter regulatory requirements.
---
## EU
Spain anchors a clinically significant EU entrant through Sequentia Biotech's IVDR-cleared gastrointestinal pathogen-detection software.
### MICK Clinical, IVDR
- **Sequentia Biotech (Barcelona, Spain):** recently achieved CE-IVD marking under the EU's In Vitro Diagnostic Regulation for MICK Clinical, its bioinformatics software solution for gastrointestinal-pathogen detection from microbiome sequencing data — a real clinical-diagnostic regulatory milestone in this category.
- **IVDR framework:** clinical microbiome diagnostic software and panels sold in the EU require conformity assessment and CE marking under the In Vitro Diagnostic Regulation (IVDR 2017/746), the bar MICK Clinical has cleared.
---
## Leading companies and research institutes
| Company / Institute | Country | Key products / platforms | Tech features | Status 2026 |
|:---|:---|:---|:---|:---|
| **Viome** | 🇺🇸 USA | *Full Body Intelligence test* | AI-powered RNA-based wellness testing | growth |
| **Codex Genetics** | 🇺🇸 USA | *Metagenomic WGS / CoGenesis panels* | Gastroenterological, gastric, metabolic panels | commercial |
| **Sequentia Biotech** | 🇪🇸 Spain | *MICK Clinical* | IVDR CE-marked GI pathogen detection | commercial |
| **Realbio Genomics** | 🇨🇳 China | *Microbiome health testing* | Domestic microbiome-testing services | growth |
| **Yaazh Xenomics** | 🇮🇳 India | *Gut microbiome test / metagenomics services* | Microbial ID, bioinformatics services | commercial |
---
## Tech stack and innovations
The stack spans consumer-facing RNA-based wellness scoring, clinical shotgun-metagenomic diagnostic panels, and regulatory-cleared bioinformatics software that turns raw sequencing data into a clinically actionable pathogen call.
1. **AI-powered RNA-based wellness scoring (Consumer Microbiome Testing):**
- Viome's Full Body Intelligence test analyzes gut microbiome RNA expression with AI-driven scoring to generate personalized health, aging and dietary recommendations for consumers.
2. **Clinical metagenomic panels (Clinical Metagenomic Panels):**
- Codex Genetics' dedicated gastroenterological, gastric and metabolic metagenomic WGS panels give clinicians pathogen and microbial-community data for specific disease-area workups.
3. **Regulatory-cleared pathogen-detection bioinformatics (Bioinformatics GI Diagnostics):**
- Sequentia Biotech's MICK Clinical software achieved IVDR CE marking for gastrointestinal-pathogen detection, demonstrating that microbiome bioinformatics can clear the same clinical-diagnostic regulatory bar as a conventional assay.
4. **Regional microbiome testing capacity (Regional Microbiome Testing):**
- Realbio Genomics and Yaazh Xenomics build domestic microbiome-testing capacity adapted to their respective markets in China and India.
---
## Value chains and production pipelines
### Industrial pipeline of a microbiome diagnostic panel (FDA LDT / EU IVDR 2017/746)
```
┌───────────────────────────┐ ┌───────────────────────────┐
│ 1. Sample collection │ ───> │ 2. Sequencing & │
│ │ │ metagenomic profiling │
└───────────────────────────┘ └───────────────────────────┘
│
▼
┌───────────────────────────┐ ┌───────────────────────────┐
│ 4. Report generation │ <─── │ 3. Bioinformatics │
│ │ │ analysis │
└───────────────────────────┘ └───────────────────────────┘
│
▼
┌───────────────────────────┐ ┌───────────────────────────┐
│ 5. Regulatory clearance │ ───> │ 6. Clinical/consumer │
│ (where clinical) │ │ action │
└───────────────────────────┘ └───────────────────────────┘
```
#### Stage 1: Sample collection
The consumer or patient collects a stool or swab sample using a provided kit, then ships it to a central sequencing lab.
#### Stage 2: Sequencing and metagenomic profiling
The lab performs shotgun metagenomic or targeted sequencing of the microbial DNA/RNA present in the sample, generating raw sequence data covering the full microbial community.
#### Stage 3: Bioinformatics analysis
Taxonomic classification and functional-pathway analysis convert raw sequence data into a microbiome composition profile, or, in the case of Sequentia Biotech's MICK Clinical, a specific pathogen-detection call.
#### Stage 4: Report generation
A consumer-facing wellness report (Viome) or a clinical diagnostic report (Codex Genetics, Sequentia Biotech) is generated from the analysis, tailored to the intended use case.
#### Stage 5: Regulatory clearance (where clinical)
Clinical-use panels require FDA LDT/CLIA status, EU IVDR CE marking, or NMPA approval before clinical adoption; consumer wellness tests generally market outside this diagnostic-device regulatory scope.
#### Stage 6: Clinical or consumer action
A clinician acts on a pathogen or dysbiosis diagnosis to guide treatment, or a consumer adjusts diet and lifestyle based on the wellness insights returned by a test like Viome's.