Diagnostic & IVD Risk Assessment
Physician and engineer-led scoring across IVD 510(k), PMA, LDT, and CLIA pathways. Clinical utility, reimbursement coding, lab workflow, and the FDA LDT final rule — in 24–48 hours.
The Problem
FDA authorization is only half the path. CPT/PLA code assignment, LCD coverage, and lab workflow fit drive real revenue. Add the LDT final rule and the AI validation gap, and the diligence surface has doubled since 2024.
FDA's 2024 rule phases laboratory-developed tests into full 510(k)/De Novo/PMA oversight by 2028. Portfolio labs running on LDT revenue need a transition plan — most don't have one.
Tests clear FDA without a PLA or CPT code, or get stuck in Category III purgatory. No code, no reimbursement, no volume. Deal models built on list price collapse.
Analytical validity is table stakes. FDA and payers now want clinical utility evidence — does the result change management? Many IVD dossiers still over-index on sensitivity/specificity.
Palmetto MolDx, Novitas, and other MACs have divergent LCDs. A test "covered by Medicare" may not be covered in the geographies your target actually sells.
A test that wins a KOL's lab won't scale to a hospital automated chemistry line. Throughput, interfaces, sample type, and middleware connectivity gate real adoption.
Locked vs adaptive algorithms, validation cohort representativeness, post-market performance monitoring. FDA's AI/ML guidance is now meaningfully enforced — gaps are material.
Regulatory Pathways We Cover
IVDs, LDTs, and CLIA-only workflows have different risk profiles — and the LDT rule is bringing a lot of "LDT forever" businesses into FDA-regulated territory. Our model reflects the pathway-specific evidence bar.
Substantial equivalence for IVDs. Analytical validity, clinical validity, predicate integrity, and risk-based controls matter most.
Companion diagnostics, some tumor markers, novel indications. Clinical utility study design, PMA panel risk, and payer alignment drive score.
Historically CLIA-only. Now phasing into FDA oversight by 2028. Risk sits in transition planning, validation documentation, and test retirement decisions.
CLIA complexity categorization, proficiency testing, inspection readiness, personnel qualification. Required regardless of FDA pathway.
Diagnostic-Specific Score Weights
Same 20-category taxonomy as every vertical. Coding, coverage, and lab workflow get more room for diagnostics than for devices. Percentage is relative contribution to the composite score.
| Domain | Weight | What we're looking at |
|---|---|---|
| Reimbursement & Coding | 22% | PLA/CPT code status, MolDx LCD coverage, MAC variance, payer policy, gap-fill vs crosswalk, prior-auth burden |
| Clinical Validity & Utility | 18% | Analytical validity (precision, accuracy, LoD), clinical validity (sensitivity/specificity), clinical utility (management impact, health-econ evidence) |
| Regulatory Pathway Integrity | 15% | Predicate choice, LDT-rule transition plan, CDx companion strategy, pre-submission correspondence, labeling alignment with intended use |
| Lab Operations & Workflow | 13% | Throughput, automation fit, LIS/middleware integration, sample type and stability, CLIA complexity, interpretation time |
| AI/ML Validation & Monitoring | 10% | Training/validation cohort representativeness, locked vs adaptive, performance monitoring plan, drift detection, subgroup performance, predetermined change control |
| IP & Freedom-to-Operate | 9% | Assay-method patents, algorithm protection, FTO on gene sequences (post-Myriad), trade secrets for reagent formulation |
| Commercial & Market Access | 8% | Physician ordering patterns, hospital-reference-lab send-out decisions, direct-contract sales model, payer contracting strategy |
| Financial & Operational | 5% | COGS, reimbursement-per-test, denial rate, days-sales-outstanding, capacity utilization — provided by buy-side |
Pricing Ladder
Start with a Quick Score to triage. Scale up to a full report when the deal moves. Every tier returns in 24–72 hours with named physician + engineer reviewers.
Want continuous monitoring post-close? Surveillance from $1,500/mo →
Diagnostic Intelligence Library
Deep dives on the diagnostic-specific risks that sink LOIs. Written by Arvind and Aswini.
PLA vs Category III vs miscellaneous code risks, MolDx LCD exposure, and the gap-fill process that determines real revenue per test.
Read → AI/ML IVDSubgroup performance, drift detection, locked-vs-adaptive posture, and predetermined change control protocols. The new FDA bar for AI diagnostics.
Read → Clinical UtilityHow to read a diagnostic's evidence package for management impact, not just test performance. The questions payers ask that most diligence skips.
Read → LDT RulePhase 1 through 5 of the 2024 final rule, what each phase requires, and how to score a lab-developed-test portfolio under the new framework.
Read → Case StudyHow a category of products watched per-test reimbursement fall 60-90% in 18 months. What the diligence could have caught, and what it couldn't.
Read → CDxLabeling coupling, post-approval trial obligations, test-drug co-marketing agreements. Why a CDx deal is two risk stacks, not one.
Read →Send us the target and a data-room link (or just the intended-use statement). We return a Quick Score in 24 hours — including LDT-rule exposure. If you want to start with a call first, we'll make time today.