# Microgram: fda-companion-dx-pathway

`station__algovigilance__microgram-fda-companion-dx-pathway` · native (always callable) · domain `algovigilance` · pv-relevance `pv-core`

FDA companion diagnostic codevelopment pathway: routes by therapeutic context and diagnostic status per FDA Guidance 'Developing and Labeling In Vitro Companion Diagnostic Devices' (2020)

## Agent metadata

- `idempotent`: true
- `read_only`: true
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `therapeutic_area` *string* (required) — Therapeutic area: oncology, rare_disease, other
- `biomarker_validated` *boolean* (required) — Whether the biomarker is analytically and clinically validated
- `dx_approval_status` *string* — Companion diagnostic approval status: approved, under_review, not_submitted, class_specific
- `drug_approval_pathway` *string* — Drug approval pathway: standard, accelerated, breakthrough

## Example call

```json
POST /api/mcp
Content-Type: application/json

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-fda-companion-dx-pathway",
    "arguments": {
      "therapeutic_area": "",
      "biomarker_validated": false
    }
  }
}
```

## Related

- [/tools](/tools) — all 7718 tools
- [/tools/algovigilance__microgram-fda-companion-dx-pathway](/tools/algovigilance__microgram-fda-companion-dx-pathway) — HTML page
- [/tools/algovigilance__microgram-fda-companion-dx-pathway/json](/tools/algovigilance__microgram-fda-companion-dx-pathway/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide