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Microgram: fda-companion-dx-pathway

station__algovigilance__microgram-fda-companion-dx-pathway native (always callable) algovigilance pv-core Constructa Configa

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

Taxonomy

Linnaean classification joined from the algovigilance taxonomy index via the parent config's rank.

Rank	Value
domain	`Substrata`
kingdom	`Constructa`
phylum	`Configa`
class	`station-config`
order	`algovigilance`
family	`mcp-tool-config`

Characteristics:

substrate: config
domain: pv
lifecycle: continuous
authority: read
compounding: producer
io: agent-request → tool-response

Input schema

therapeutic_area stringrequired — Therapeutic area: oncology, rare_disease, other
biomarker_validated booleanrequired — 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

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
    }
  }
}

How to invoke from a client

From any MCP-aware client, add https://algovigilance.com/api/mcp as an MCP server, then call this tool by name. From a raw HTTP client, send the JSON-RPC body above to /api/mcp.

Agent-friendly formats

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