{ "affiliate_slug": "viome-life-sciences", "claims": [ { "checked_at": "2026-09-20T00:00:00Z", "claim_id": "claim:t--viome-gut-intelligence:measurement.availability", "denominator": 3, "denominator_status": "ok", "denominator_unit": "integrity components", "entity_id": "test:viome-gut-intelligence", "number": 0, "page_id": "t--viome-gut-intelligence", "provenance": "measurements.csv", "query": "measurement repeatability/interlab/independent_validation non-null availability", "query_commit": "90a5050d2327baae3d738638237b48fb29cb01b0", "query_id": "measurement.availability", "query_links": [], "rows_after_dedupe": 0, "rows_before_dedupe": 3, "rule_id": "measurement.availability", "sentence": "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.", "snapshot_hash": "b7633f732437b71d37c215a03b19abfa8c91d45411579d976d6a926a0140339a", "status": "ok", "template_id": "measurement.availability", "values_json": "{\"denominator\": 3, \"interlab\": \"undefined: not recorded\", \"labels\": \"labels in the NIH DSLD snapshot (Sep 2026)\", \"name\": \"Viome Gut Intelligence\", \"number\": 0, \"reason\": \"insufficient open validation fields\", \"repeatability\": \"undefined: not recorded\", \"share\": \"0.0%\", \"validation\": \"undefined: not recorded\", \"window\": \"NIH DSLD snapshot Sep 2026\"}", "window": "NIH DSLD snapshot Sep 2026" }, { "checked_at": "2026-09-20T00:00:00Z", "claim_id": "claim:t--viome-gut-intelligence:measurement.regulatory", "denominator": 3, "denominator_status": "ok", "denominator_unit": "regulatory descriptor fields", "entity_id": "test:viome-gut-intelligence", "number": 2, "page_id": "t--viome-gut-intelligence", "provenance": "measurements.csv", "query": "recorded marketing route, clearance_found and intended_use_match; source date preserved", "query_commit": "90a5050d2327baae3d738638237b48fb29cb01b0", "query_id": "measurement.regulatory", "query_links": [], "rows_after_dedupe": 2, "rows_before_dedupe": 3, "rule_id": "measurement.regulatory", "sentence": "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2 of 3 regulatory descriptor fields are recorded; route DTC wellness (LDT-type; FDA LDT rule vacated 2025-03-31, rescinded 2025-09-19); clearance found False; intended-use match undefined: not recorded; checked 2026-09-07; scope openFDA 510(k)/De Novo by applicant 'Viome' — re-run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.", "snapshot_hash": "b7633f732437b71d37c215a03b19abfa8c91d45411579d976d6a926a0140339a", "status": "ok", "template_id": "measurement.regulatory", "values_json": "{\"clearance\": \"False\", \"date\": \"2026-09-07\", \"denominator\": 3, \"intended\": \"undefined: not recorded\", \"labels\": \"labels in the NIH DSLD snapshot (Sep 2026)\", \"name\": \"Viome Gut Intelligence\", \"number\": 2, \"route\": \"DTC wellness (LDT-type; FDA LDT rule vacated 2025-03-31, rescinded 2025-09-19)\", \"scope\": \"openFDA 510(k)/De Novo by applicant 'Viome' — re-run in W0\", \"share\": \"66.7%\", \"window\": \"NIH DSLD snapshot Sep 2026\"}", "window": "NIH DSLD snapshot Sep 2026" }, { "checked_at": "2026-09-20T00:00:00Z", "claim_id": "claim:t--viome-gut-intelligence:measurement.price", "denominator": 1, "denominator_status": "ok", "denominator_unit": "report-price fields", "entity_id": "test:viome-gut-intelligence", "number": 1, "page_id": "t--viome-gut-intelligence", "provenance": "measurements.csv", "query": "measurement price_usd with source and observed_at; no current-price assertion", "query_commit": "90a5050d2327baae3d738638237b48fb29cb01b0", "query_id": "measurement.price", "query_links": [], "rows_after_dedupe": 1, "rows_before_dedupe": 1, "rule_id": "measurement.price", "sentence": "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.", "snapshot_hash": "b7633f732437b71d37c215a03b19abfa8c91d45411579d976d6a926a0140339a", "status": "ok", "template_id": "measurement.price", "values_json": "{\"denominator\": 1, \"labels\": \"labels in the NIH DSLD snapshot (Sep 2026)\", \"name\": \"Viome Gut Intelligence\", \"number\": 1, \"price_text\": \"USD 199, vendor site (orchestrator note; verify at build), observed 2026-09-07\", \"share\": \"100.0%\", \"window\": \"NIH DSLD snapshot Sep 2026\"}", "window": "NIH DSLD snapshot Sep 2026" }, { "checked_at": "2026-09-20T00:00:00Z", "claim_id": "claim:t--viome-gut-intelligence:measurement.evidence", "denominator": 0, "denominator_status": "ok", "denominator_unit": "catalog RCT entries", "entity_id": "test:viome-gut-intelligence", "number": 0, "page_id": "t--viome-gut-intelligence", "provenance": "measurements.csv", "query": "measurement catalog n_rct and validation_pubs_count; counts are catalog entries, not deduplicated class totals", "query_commit": "90a5050d2327baae3d738638237b48fb29cb01b0", "query_id": "measurement.evidence", "query_links": [], "rows_after_dedupe": 0, "rows_before_dedupe": 0, "rule_id": "measurement.evidence", "sentence": "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.", "snapshot_hash": "b7633f732437b71d37c215a03b19abfa8c91d45411579d976d6a926a0140339a", "status": "ok", "template_id": "measurement.evidence", "values_json": "{\"denominator\": 0, \"evidence_note\": \"No indexed strain-level randomized human trial report was found in this ledger version. Technology-class total undefined: no deduplicated class ledger.\", \"labels\": \"labels in the NIH DSLD snapshot (Sep 2026)\", \"name\": \"Viome Gut Intelligence\", \"number\": 0, \"share\": \"undefined: no observations\", \"validation_n\": 0, \"window\": \"NIH DSLD snapshot Sep 2026\"}", "window": "NIH DSLD snapshot Sep 2026" } ], "cohort_manifest_sha256": "3a8805d95e34cbd3ccdc36613e5bbcd4a75c17b7e07e420b65aa54f786a13400", "compared_with": [ { "name": "Viome Gut Intelligence vs GI-MAP", "other_name": "GI-MAP", "other_route": "/t/gi-map/", "route": "/vs/viome-gut-intelligence-vs-gi-map/" }, { "name": "Tiny Health vs Viome Gut Intelligence", "other_name": "Tiny Health", "other_route": "/t/tiny-health/", "route": "/vs/tiny-health-vs-viome-gut-intelligence/" }, { "name": "ZOE vs Viome Gut Intelligence", "other_name": "ZOE", "other_route": "/t/zoe-test/", "route": "/vs/zoe-test-vs-viome-gut-intelligence/" } ], "entity_id": "test:viome-gut-intelligence", "evidence": { "aggregate_key": "", "as_of": "2026-09-07", "conditions_json": "[]", "ctgov_error": "", "ctgov_interventional_count": null, "ctgov_query": "", "ctgov_query_valid": null, "ctgov_retrieved_at": "", "ctgov_status": "not_queried", "direction": "", "direction_balance": "", "dose_unit": "", "entity_id": "test:viome-gut-intelligence", "evidence_amount": 0, "evidence_member_id": "test:viome-gut-intelligence", "evidence_source": "canary", "matched_records_json": "[]", "max_studied_dose": "", "minimum_tested_positive_dose": "", "n_participants": "", "n_rct_human": 0, "pmid_ids_json": "[]", "pmid_level": "1", "pmids_loaded": 0, "pubmed_error": "", "pubmed_status": "not_queried", "query": "Viome[tiab] AND (metatranscriptom* OR validation OR reproducib*)", "query_valid": true, "rct_count": 0, "records_after_title_year_dedupe": 0, "retracted_count": 0, "retraction_checked_at": "2026-09-07", "retractions_excluded": false, "rob_flag": "", "rows_after_dedupe": 0, "rows_before_dedupe": 0, "sponsor_share": "", "status": "ok", "taxon_in_ncbi": null, "term": "", "truncated": "0", "zero_phrase": "No indexed strain-level randomized human trial report was found in this ledger version" }, "formula_version": "gis_v1", "generated_at": "2026-09-20T00:00:00Z", "measurand_count": 3, "measurement": { "A3": null, "A3_reason": "repeatability_and_interlab_not_defined", "A3_status": "unscored", "affiliate": { "cookie_days": 30, "program": "Viome affiliates (Impact)", "rate": "8%" }, "canonical_name": "Viome Gut Intelligence", "clearance_found": false, "demand": { "viome": 18100, "viome review": 6600 }, "entity_id": "test:viome-gut-intelligence", "entity_type": "test", "fda_ref": "no 510(k)/De Novo record found for Viome gut test in openFDA (search 2026-09-07)", "fda_status": "LDT_no_review", "independent_validation": null, "intended_use_match": null, "interlab": null, "marketing_route": "DTC wellness (LDT-type; FDA LDT rule vacated 2025-03-31, rescinded 2025-09-19)", "n_rct": 0, "nist_participation": "anonymous", "nist_ref": "NIST DTC gut microbiome interlaboratory study names no vendors", "price_observed_at": "2026-09-07", "price_source": "vendor site (orchestrator note; verify at build)", "price_usd": 199, "raw_data_export": "unknown", "regulatory_checked_at": "2026-09-07", "repeatability_cv": null, "repeatability_icc": null, "report_outputs": [ "microbial activity scores", "food recommendations", "supplement recommendations" ], "reported_measurements": null, "search_scope": "openFDA 510(k)/De Novo by applicant 'Viome' — re-run in W0", "slug": "viome-gut-intelligence", "technology": "metatranscriptomics (RNA sequencing of stool)", "trustpilot": { "n": 3428, "observed_at": "2026-09-06", "rating": 3.5 }, "turnaround_days": null, "undefined_reason": "insufficient open validation fields", "validation_pubs_count": 0, "validation_query": "Viome[tiab] AND (metatranscriptom* OR validation OR reproducib*)", "validation_refs": [], "vendor": "Viome Life Sciences" }, "name": "Viome Gut Intelligence", "other_measurements": [ { "name": "GI-MAP", "route": "/t/gi-map/" }, { "name": "Gut Zoomer", "route": "/t/gut-zoomer/" }, { "name": "Tiny Health", "route": "/t/tiny-health/" }, { "name": "Ombre", "route": "/t/ombre/" }, { "name": "BIOHM", "route": "/t/biohm/" }, { "name": "ZOE", "route": "/t/zoe-test/" }, { "name": "trio-smart", "route": "/t/trio-smart/" }, { "name": "FoodMarble AIRE 2", "route": "/d/foodmarble-aire-2/" }, { "name": "Withings U-Scan", "route": "/d/withings-u-scan/" }, { "name": "Kohler Dekoda", "route": "/d/kohler-dekoda/" } ], "page_id": "t--viome-gut-intelligence", "page_type": "measurement", "panels": [], "price": { "observed_at": "2026-09-07", "price_per_report_usd": 199, "source": "vendor site (orchestrator note; verify at build)" }, "price_per_measurand": 66.33, "related_reports": [ { "name": "Gut test evidence counts", "route": "/reports/gut-test-evidence-counts/" }, { "name": "Seed review types", "route": "/reports/seed-review-types/" } ], "related_tools": [ { "name": "Test decision tree", "route": "/which-test/" } ], "release": "2026-09-20", "route": "/t/viome-gut-intelligence/", "score_scale": 100, "source_sha256": "b7633f732437b71d37c215a03b19abfa8c91d45411579d976d6a926a0140339a", "weights": { "A1": 0.45, "A2": 0.55 } }