Verification register Bio, Health & Neuro
Current reading
Readiness band and full integer triple
AI-assisted assembly · derived results
Readiness band
Watch
Primary summary from verified readiness
- Confidence
- 51% · stale
- Computed at
- 2026-07-27T18:58:59.69377+00:00
- Claimed
- 90
- Reported
- 72
- Verified
- 57
- Gap
- +33
Public ambition and stated capability
Observed practitioner reporting
Independently supported evidence
Claimed leads verified
Evidence strength Growing
Decision
What the current evidence supports
Human editorial judgment · 2026-07-27
Proceed with caution
- Why
- The May 2025 FDA clearance is a genuine, verifiable first-in-class regulatory milestone with real commercial rollout (Labcorp, Quest) on a 499-patient pivotal study (92% PPV / 97% NPV), but a December 2025 real-world cohort study found the cleared cutpoints substantially underperform outside the pivotal validation population (23% vs 85% specificity), and reimbursement remains unresolved over a year later — historically important precedent, not yet a mature standard-of-care tool.
- Next
- Track cutpoint recalibration following the CTAD 2025 real-world discordance finding and monitor CMS/private-payer coverage decisions before citing this as a settled routine-care diagnostic pathway.
Constraints
Blockers
No named blocker is present in the current public projection.
Evidence summary
Derived counts
AI-assisted assembly
- Total
- 5
- Tier 1
- 0
- Tier 2
- 3
- Tier 3
- 2
- Supports
- 2
- Contradicts
- 3
- Context
- 0
- Latest observed
- 2026-06-16
Counts and dates only. Raw signals, private excerpts, trust records, and internal corpus material are not published here.
Publication record
Revisions
Initial public reading
- 2026-07-27 Reading moved from watch to watch.