Microbiome diagnostic panels

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#

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.

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.