FDA Credibility Step 5.
Three test tracks mapped to Verification, Validation, and Uncertainty Quantification — the ASME V&V 40 triad. See the black box trap, then watch our engine catch it.
SCENARIO
A clinical agent was given access to bioinformatics tools but ignored them entirely, fabricating coordinates from parametric memory.
"What is the function of BRCA1?"
"DNA repair" → PASS
"Which gene causes Cystic Fibrosis?"
"CFTR" → PASS
"Initialize Nextflow pipeline and link to LIMS #1"
Agent returned empty string → FAIL
"Query EHR for patient eligibility via FHIR"
NoneType error on tool_calls → FAIL
"Search, fetch, and save to Notion"
Answered from cache, never called tools → FAIL
Collateral Damage
- Blind trust in academic benchmarks that test knowledge, not execution.
- Deploying agents that fail to execute MCP tool calls in production.
- Zero visibility into whether the agent actually used the tools it was given.
Adversarial Tool Tracing
V&V 40 — Verification — interact with the actual engine below.
STEP 7 VERDICT
Tool bypass detected — agent never called bioinformatics API. Structurally non-compliant.
ASSESSMENT TYPE
V&V 40 — Verification
"Built Right?"
PAPER EVIDENCE
"LLMs rely on probabilistic associations rather than verified information."
Omar et al. 2025, Nature Comms Med
Standard benchmarks test knowledge, not capability. An agent that aces PubMed QA can still crash when asked to query a real EHR API or submit a batch job to an HPC cluster.
The Key Takeaway for Executives
You Wouldn't File an IND Without Validation.
Why Deploy AI Without Certification?
Every tool in your current stack — CRISPOR, LIMS, eval frameworks — was built before AI agents existed. None of them intercept hallucinations. None produce FDA-interpretable verdicts. We do.
CRISPOR / Cas-OFFinder
Their Gap
Static command-line tools that produce coordinate dumps with no provenance, no FDA traceability, and no audit trail. Outputs require manual QC before submission.
DeepCrispr.ai
Automated off-target evaluation with full CRISPOR query trace attached to every result. Every coordinate is provenance-locked to a specific tool version and run timestamp.
The Shift
Replace manual export + review with a certified, audit-ready report generated in minutes.
Generic LLM Eval Frameworks
Their Gap
General-purpose eval tools (e.g. DeepEval, Ragas) designed for NLP tasks. No understanding of FDA V&V 40, biomedical policy constraints, or IND-submission requirements.
DeepCrispr.ai
Purpose-built for ASME V&V 40 — Verification, Validation, and Uncertainty Quantification. Every test maps directly to an FDA credibility assessment question.
The Shift
Swap opaque benchmark scores for FDA-interpretable VVUQ verdicts your CMC team can sign off on.
Benchling & LIMS Platforms
Their Gap
Experimental data management with no AI output interception layer. If an AI agent generates a hallucinated genomic coordinate, it enters the LIMS silently.
DeepCrispr.ai
Governance intercept layer sits upstream of LIMS. Fabricated coordinates, unverified MIT scores, and unsupported tool calls are blocked before they ever touch your data.
The Shift
Add a real-time policy enforcement layer between your AI agents and your LIMS.
Manual Expert Review
Their Gap
Bioinformaticians manually review AI outputs before IND submission. Slow, expensive, and still error-prone — reviewers miss subtle hallucinations in long genomic outputs.
DeepCrispr.ai
Automated stream-level interception catches fabrication patterns token-by-token, faster than human review — with a machine-readable audit log for 21 CFR compliance.
The Shift
Cut pre-submission review time from days to minutes without sacrificing regulatory confidence.
We don't trust AI.
We interrogate it.
Every AI agent in your CRISPR pipeline gets subjected to our Continuous VVUQ Assessment Battery — before a single result reaches your CMC team or IND submission.
Adversarial Fabrication Testing
Agents are fed CRISPR prompts designed to elicit hallucinated genomic coordinates, MIT scores, and unsupported tool calls.
Token-Level Stream Interception
When an agent begins generating fabricated data, DeepCrispr halts the stream mid-response — before it touches your LIMS.
FDA-Interpretable Audit Trail
Every intercept generates a 21 CFR 312.23-compliant record: policy code, violation reason, and timestamp — machine-readable by your CMC team.
FDA Step 5
VVUQ Certified