Gut Registry

measurement · release 2026-09-20

Viome Gut Intelligence

Structured fields rendered from the release dataset. Unknown values retain a reason; price is outside GIS.

Validation publications0
RCT count0
Price per report199
Price per measurand$66.33

Axes 1–2

Input and evidence

Technology: metatranscriptomics (RNA sequencing of stool). Evidence records: 0.

Axis 3

Measurement integrity

Status
There is not enough information to score this axis. Repeatability and agreement between laboratories have not been established in the available data.
Repeatability ICC
undefined
Repeatability CV
undefined
Interlab
undefined
Independent validation
undefined
Marketing route
DTC wellness (LDT-type; FDA LDT rule vacated 2025-03-31, rescinded 2025-09-19)
Clearance found
false
Intended-use match
undefined
Search scope
openFDA 510(k)/De Novo by applicant 'Viome' — re-run in W0
Checked
2026-09-07

What you get

What the test delivers, and on what terms

Vendor
Viome Life Sciences
Method
metatranscriptomics (RNA sequencing of stool)
Raw data export
the vendor states raw data can be exported
Price observed
$199 per report, observed 2026-09-07, source: vendor site (orchestrator note; verify at build); $66.33 per reported measurand
Regulatory reference
no 510(k)/De Novo record found for Viome gut test in openFDA (search 2026-09-07)
Validation publications
0 found by the recorded query: Viome[tiab] AND (metatranscriptom* OR validation OR reproducib*)

Measurand catalog

Non-duplicate outputs

Other tests

Other measurement products in this release

GI-MAP · Gut Zoomer · Tiny Health · Ombre · BIOHM · ZOE · trio-smart · FoodMarble AIRE 2 · Withings U-Scan · Kohler Dekoda

Elsewhere in this release

Related pages

Compared side by side: Viome Gut Intelligence vs GI-MAP · Tiny Health vs Viome Gut Intelligence · ZOE vs Viome Gut Intelligence

Findings computed over the whole corpus: Gut test evidence counts · Seed review types

Tools: Test decision tree

Citation

Cite this page

Ivitskiy, I. (2026). Viome Gut Intelligence. Gut Registry, release 2026-09-20. Elanvale Ltd. https://gutregistry.com/t/viome-gut-intelligence/

The underlying tables are published under CC BY 4.0: this page as CSV · as JSON · full release and data dictionary. Cell-level provenance names the source record and its observation date.

Citable atoms

Release claims

  1. Viome Gut Intelligence: 0 of 3 measurement-integrity components are available; repeatability undefined: not recorded, interlab undefined: not recorded, independent validation undefined: not recorded. insufficient open validation fields. Window: NIH DSLD snapshot Sep 2026.

    0 / 3 integrity components · NIH DSLD snapshot Sep 2026 · measurement.availability · checked 2026-09-20T00:00:00Z · snapshot b7633f732437

  2. Viome Gut Intelligence: 2 of 3 regulatory descriptor fields are recorded; route DTC wellness (LDT-type; FDA LDT rule vacated 2025-03-31, rescinded 2025-09-19); clearance found False; intended-use match undefined: not recorded; checked 2026-09-07; scope openFDA 510(k)/De Novo by applicant 'Viome' — re-run in W0. Window: NIH DSLD snapshot Sep 2026.

    2 / 3 regulatory descriptor fields · NIH DSLD snapshot Sep 2026 · measurement.regulatory · checked 2026-09-20T00:00:00Z · snapshot b7633f732437

  3. Viome Gut Intelligence: 1 of 1 report-price fields are available; USD 199, vendor site (orchestrator note; verify at build), observed 2026-09-07. Window: NIH DSLD snapshot Sep 2026.

    1 / 1 report-price fields · NIH DSLD snapshot Sep 2026 · measurement.price · checked 2026-09-20T00:00:00Z · snapshot b7633f732437

  4. Viome Gut Intelligence: 0 RCTs recorded for this technology entry among 0 RCTs recorded across the test/device catalog; 0 validation publications. No indexed strain-level randomized human trial report was found in this ledger version. Technology-class total undefined: no deduplicated class ledger. Window: NIH DSLD snapshot Sep 2026.

    0 / 0 catalog RCT entries · NIH DSLD snapshot Sep 2026 · measurement.evidence · checked 2026-09-20T00:00:00Z · snapshot b7633f732437

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