Products & services directory

FDA-approved December 2022. PUNCH CD3 trial: 70.6% sustained clinical response at 8 weeks vs 57.5% placebo. First FDA-approved fecal microbiota product.

FDA-approved April 2023. ECOSPOR III trial: 87.6% sustained response at 8 weeks vs 60.4% placebo (p<0.001). First orally administered FDA-approved microbiome therapeutic.

Multiple meta-analyses support efficacy for AAD prevention (NNT ~10). AGA conditionally recommends for C. diff prevention in adults on antibiotics. Strain-specific evidence from >50 RCTs.

Strain-specific evidence from >20 RCTs for pediatric AAD prevention. AGA-recommended in specific pediatric contexts. Also studied for acute gastroenteritis (modest benefit), atopic dermatitis prevention (mixed).

Multiple RCTs demonstrate improvement in IBS global symptoms vs placebo. Whorwell et al. (2006) showed dose-dependent benefit at 10⁸ CFU. One of the few probiotics with IBS-specific evidence at a defined dose.

The De Simone Formulation (previously sold as VSL#3) has RCT evidence for pouchitis maintenance and UC adjunct therapy. AGA conditional recommendation for pouchitis. Note: VSL#3 and Visbiome are now different products due to a legal dispute; Visbiome contains the original formulation.

Depommier et al. (2019, Nat Med) Phase I/II showed pasteurized A. muciniphila improved insulin sensitivity and reduced cholesterol in overweight/obese subjects. Pendulum's formulation is live (not pasteurized). Their own trial (2024) showed improvement in A1c in T2DM patients on metformin.

Individual strains have varying levels of evidence. The specific combination has been tested in company-funded studies for gut barrier function, stool consistency, and skin outcomes. Published in peer-reviewed journals but needs independent replication.

Soluble fiber supplementation is well-established for increasing SCFA production and supporting commensal bacteria. Not strain-specific — feeds a broad range of bacteria. The simplest, best-supported intervention for most people.

Multiple RCTs show increased Bifidobacterium within 1 week of supplementation. Silk et al. (2009) showed improvement in IBS symptoms. One of the better-studied specific prebiotics. Also studied for reducing traveler's diarrhea incidence.

Based on PREDICT study data (Berry 2020, Nat Med). The science behind individual metabolic variation is real. ZOE's app translates this into food scores. Company-funded validation studies published in peer-reviewed journals.

Uses metatranscriptomics (gene expression), which is theoretically more informative than 16S or shotgun DNA. However, no published RCTs demonstrate health outcomes from following Viome recommendations. The personalized supplement formulations have not been clinically validated.

Uses validated sequencing methods. Provides compositional data, diversity scores, and functional predictions. Recommendations are algorithm-generated, not guideline-based.

The MiSeq is the most widely cited benchtop sequencer in microbiome literature. 16S V3–V4 amplicon sequencing on MiSeq is the de facto standard used in the Human Microbiome Project, Earth Microbiome Project, and thousands of clinical studies. FDA has cleared multiple MiSeqDx-based IVD assays (e.g., cystic fibrosis panels). Sequencing chemistry (SBS — sequencing by synthesis) is mature and well-characterized with known error profiles (substitution-dominant, ~0.1% per base).

The NovaSeq X series represents Illumina's highest-throughput platform. XLEAP-SBS chemistry reduces error rates to ~0.5% (Q30 >90%). Patterned flow cells enable consistent cluster density. Used in major population genomics projects (UK Biobank, All of Us). For microbiome applications, enables cost-effective deep shotgun metagenomics at scale — essential for strain-level resolution and functional profiling that 16S cannot provide.

Combines benchtop convenience with sufficient throughput for shotgun metagenomics. P2 and P3 flow cells offer flexible output (30–360 Gb). XLEAP chemistry matches NovaSeq X error rates. Increasingly adopted for clinical metagenomics where MiSeq throughput is limiting but NovaSeq capital cost is prohibitive.

Nanopore's long reads enable species-level resolution via full-length 16S (V1–V9, ~1,500 bp) — impossible with Illumina short reads. Real-time basecalling allows pathogen identification in minutes. Published applications in outbreak investigation (Ebola, Zika, COVID-19), antimicrobial resistance surveillance, and point-of-care diagnostics. Accuracy has improved dramatically: R10.4.1 chemistry + latest basecallers achieve Q20+ (>99% modal accuracy) for simplex reads and Q30+ with duplex reads.

PromethION addresses nanopore's historical throughput limitation. A single flow cell can generate enough data for deep shotgun metagenomics of multiple samples. Long reads enable strain-resolved metagenome-assembled genomes (MAGs) with far fewer chimeric contigs than short-read assemblies. Duplex sequencing achieves Q30+ accuracy. Published studies demonstrate superior resolution of mobile genetic elements, phage-host interactions, and horizontal gene transfer events.

PacBio HiFi reads combine long-read length (15–20 kb average) with short-read-level accuracy (>Q30). This is achieved via circular consensus sequencing (CCS): the polymerase reads each molecule multiple times, and consensus corrects errors. For metagenomics, HiFi reads produce superior MAGs with higher contiguity and fewer errors than either short reads or uncorrected long reads. Native 5mC methylation detection enables epigenetic profiling of microbial communities without bisulfite conversion.

Ion Torrent's semiconductor sequencing detects hydrogen ions released during DNA polymerization — no fluorescence or cameras required. The Genexus system automates the entire NGS workflow (library prep → sequencing → analysis) in ~24 hours. FDA 510(k)-cleared for multiple oncology assays. For microbiology, Ion 16S Metagenomics Kit targets 7 hypervariable regions simultaneously (V2–V9). Published applications in clinical metagenomics and AMR surveillance.

DNBSEQ platforms use a unique rolling-circle amplification to create DNA Nanoballs (DNBs) that are loaded onto patterned nanoarrays — eliminating the index hopping problem inherent to Illumina's bridge amplification on patterned flow cells. The Human Microbiome Metagenomics Package has been validated on >130,000 stool samples with excellent intra-platform reproducibility (gene-level r >0.91, species-level r >0.97) and strong cross-platform consistency with Illumina (gene richness r >0.99). Published in large-cohort studies including multiple Chinese population-scale microbiome projects. The DNBSEQ-T7 processes up to 220,000 samples/year; the newer T20×2RS scales to 450,000 samples/year. Cost per Gb is 30–50% lower than equivalent Illumina platforms at scale.

Digital PCR (dPCR) partitions each sample into thousands of individual reactions, enabling absolute quantification without reference standards. Published applications include: quantification of fecal pathogen loads (C. diff toxin genes), monitoring FMT engraftment via donor-specific strain markers, validation of 16S sequencing relative abundance data, and detection of low-abundance AMR genes below qPCR detection limits.

Bio-Rad's ddPCR is the most widely published digital PCR platform. Droplet partitioning (~20,000 droplets/reaction) provides robust Poisson statistics for absolute quantification. Published microbiome applications include: C. diff toxin gene quantification, FMT engraftment monitoring, low-level pathogen detection in complex samples, and validation of metagenomic relative abundance data.

Extraction method is the single largest source of technical bias in microbiome studies — more impactful than sequencing platform or bioinformatics pipeline (Costea et al. 2017, Nat Biotechnol). ZymoBIOMICS kits are specifically designed to minimize this bias via combined mechanical (bead-beating) and chemical lysis. The ZymoBIOMICS Microbial Community Standard (mock community) enables end-to-end quality control. Published in hundreds of microbiome studies as the extraction method of choice.

The original MO BIO PowerSoil kit (now QIAGEN DNeasy PowerSoil Pro) is specified in the Earth Microbiome Project (EMP) standard protocol, making it the most widely used extraction kit in microbiome research globally. IRT chemistry is particularly effective at removing inhibitors from stool and soil — critical for downstream PCR and sequencing. Extensively validated across thousands of published studies.

AVITI uses a novel avidity-based chemistry (multivalent binding) that achieves accuracy comparable to Illumina SBS at lower reagent cost. Published benchmarks show Q30 >90% and concordant variant calling with Illumina. Early microbiome publications demonstrate comparable community profiles to Illumina for both 16S and shotgun applications. The platform is gaining adoption in academic and clinical labs seeking to reduce per-sample sequencing costs.

Ultima's $1/Gb price point (if achieved at scale) would make deep shotgun metagenomics cost-comparable to current 16S amplicon pricing, potentially transforming microbiome research. Early publications show concordant results with Illumina for whole-genome sequencing. Microbiome-specific validation is limited but emerging.

FDA-cleared (De Novo pathway) as a prescription digital therapeutic for IBS. Randomized controlled trial showed significant improvement in IBS-SSS scores vs control. CBT for IBS is guideline-supported (AGA, ACG).

Not a microbiome product — but dietary fiber is the single best-supported intervention for gut microbiome health. Tracking fiber intake helps patients reach the 25–38g/day target. Cronometer specifically tracks fiber subtypes.

Traditional kefir contains a more diverse microbial community than commercial yogurt. Some RCTs show improved lactose digestion and modest GI symptom improvement. Part of the fermented foods category that increased diversity in the Stanford study (Wastyk 2021).

Included in the Stanford fermented food study that showed increased gut microbial diversity and decreased inflammatory markers (Wastyk 2021). Must be raw/unpasteurized to contain live cultures — shelf-stable sauerkraut is heat-treated and has no live organisms.

Contains some prebiotic fiber and probiotic cultures, but the strains are not clinically characterized for specific health outcomes. No published RCTs on the AG1 formula for any health outcome. Individual ingredient evidence doesn't validate the combination.

High CFU count and strain diversity sound impressive but have no established dose-response advantage. Individual strains are identified but the specific combination has never been tested in RCTs. 'More strains = better' is a marketing proposition, not a scientific finding.

Built on well-established oral-systemic research linking P. gingivalis to periodontitis and cardiovascular risk, Solobacterium moorei to halitosis (volatile sulfur compound production), and oral nitrate-reducing bacteria to blood pressure regulation. Every claim on the platform is tiered (A/B/C) with linked citations and last-reviewed dates. AI outputs are disclosed under EU AI Act Article 50 with a public model card. Not an in-vitro diagnostic (IVD) under EU IVDR 2017/746 — positioned as clinical-decision support.

Combines three anatomical sites in one test — a differentiator from single-site competitors. Shotgun + metatranscriptomic sequencing provides functional (gene expression) data beyond taxonomic snapshots. HelixAI™ generates composite health scores and 67 personalized food matches. The multi-site approach aligns with emerging research on oral-gut-vaginal microbiome crosstalk (Atarashi et al., Science 2017; Aagaard et al., Sci Transl Med 2014). AI insights are continuously updated as new research is published. Personalized supplement and probiotic recommendations included.