Methodology

How the biomarker benchmark works

Biomarker Patient-Selection Radar is a public-data screening and benchmarking tool. It does not provide medical advice, regulatory advice, legal advice, patent-validity opinions, freedom-to-operate opinions, investment advice, or diagnostic-development recommendations. FDA CDx context is interpreted narrowly by biomarker, drug, indication, and device/test context where available. Findings should be reviewed by qualified clinical, regulatory, diagnostic, legal, and business experts before use.

Data sources

Reference set

  • ClinicalTrials.gov API v2
  • FDA companion diagnostic device list (local curated MVP file)
  • USPTO / PatentsView compatible local fallback sample
  • Treelip curated biomarker dictionary
Disclaimer

Conservative use only

Biomarker Patient-Selection Radar is a public-data screening and benchmarking tool. It does not provide medical advice, regulatory advice, legal advice, patent-validity opinions, freedom-to-operate opinions, investment advice, or diagnostic-development recommendations. FDA CDx context is interpreted narrowly by biomarker, drug, indication, and device/test context where available. Findings should be reviewed by qualified clinical, regulatory, diagnostic, legal, and business experts before use.

Framework area

Data sources

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Biomarker dictionary

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Trial cohort definition

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Biomarker role classification

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Threshold extraction

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Tumor-type and drug-context extraction

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

FDA CDx context mapping

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Diagnostic patent-density appendix

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Scoring logic

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Strategy labels

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Manual review process

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Limitations

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.

Framework area

Disclaimer

This section documents deterministic role classification, threshold extraction, FDA CDx mapping, and manual-review workflow from public data.