Decision catalogueModality pressure-test
Assay performance is not the whole diagnostics investment claim
Decision problem
Do analytical claims, intended use, and path-to-adoption cohere under the stated clock?
Thesis
A strong ROC curve on a convenience cohort does not underwrite adoption or regulatory classification risk.
Diagnostics packages often lead with analytical performance. The investment claim also requires intended-use coherence: who is tested, where, with what confirmatory path, and under which regulatory posture.
CLIA, LDT, and FDA classification ambiguity is financing-material when timeline and reimbursement depend on it. Workflow claims that ignore operator burden or confirmation testing realities leave adoption unresolved.
The review maps claim → evidence → adoption constraint. Classification or reimbursement still stated as narrative becomes an explicit unresolved domain in the memo — visible in the memo rather than soft-pedaled.
Claim map
Must-be-true cuts a Decision Sprint memo would force
- Sensitivity/specificity or clinical validity claims hold for the stated use
- Sample-to-answer workflow assumptions match real operating environments
- Regulatory and reimbursement paths are decision-grade for the stated timeline
Decision triggers
Outputs from the claim test that should change the conversation
- Performance claimed on convenience cohorts rather than intended-use populations
- CLIA / FDA / LDT classification ambiguity material to timeline
- Adoption thesis ignoring workflow or confirmation-testing realities
Sources
Related in the catalogue
- Prior work · Diagnostics
Anonymized account of decision pressure in this modality class.
- Method · graph-backed claim testing
How claims are decomposed, tested against the evidence graph, and turned into decision outputs.
- Claim maps beat generic diligence checklists for seed decisions
How should a lean team pressure-test science under a 5–20 day deal deadline?
- When not to buy outsourced diligence
When does an outsourced science review create no decision value?
Facing this cut on a live $1–10M package?
Scope a Decision Sprint for one opportunity under your deal deadline—claim map, risk register, management questions, and partner briefing.