# THxID BRAF Kit

Source: https://onco.cc/drugs/thxid-braf/  
OnCo record `thxid-braf` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

bioMérieux's BRAF test for melanoma, approved with dabrafenib and trametinib in 2013; the FDA's device database records its approval as withdrawn in 2024.

## Summary

bioMérieux's THxID BRAF Kit was approved on 29 May 2013 (PMA P120014) as the companion diagnostic for dabrafenib (V600E) and trametinib (V600E or V600K) in melanoma; a supplement on 27 June 2018 added encorafenib with binimetinib. The FDA PMA database records a withdrawal date of 24 June 2024, although the kit still appeared on the FDA companion diagnostic list when both were read on 3 November 2026. Other approved tests, such as FoundationOne CDx, carry BRAF claims for these drugs.

## Fields

- Kind: Test
- Status: withdrawn
- Last checked: 2026-11-03
- Also known as: THXID BRAF Kit; bioMérieux THxID BRAF
- Tags: test
- Brand: THxID BRAF
- Modality: PCR companion diagnostic test (BRAF V600E and V600K, melanoma tissue)
- Mechanism: Detects BRAF V600E and V600K mutations in DNA from melanoma tissue.
- Approvals: US 2013: Companion diagnostic for dabrafenib (V600E) and trametinib (V600E or V600K) in melanoma; US 2018: Companion diagnostic for encorafenib with binimetinib

## Notes

- PMA P120014 shows a withdrawal date of 24 June 2024 in the FDA PMA database (read 3 November 2026).

## Sources

- FDA PMA P120014: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120014
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- drugs: [Binimetinib](https://onco.cc/drugs/binimetinib/), [cobas 4800 BRAF V600 Mutation Test](https://onco.cc/drugs/cobas-4800-braf-v600/), [Dabrafenib](https://onco.cc/drugs/dabrafenib/), [Encorafenib](https://onco.cc/drugs/encorafenib/), [Trametinib](https://onco.cc/drugs/trametinib/)
- biomarkers: [BRAF V600E (and V600K)](https://onco.cc/biomarkers/braf-v600e/)
- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [BRAF](https://onco.cc/targets/braf/)
- companies: [bioMérieux](https://onco.cc/companies/biomerieux/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)

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