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    TEST:
    THXID® BRAF Kit

    Company:
    bioMérieux
    Type:
    FDA Approved
    6d
    NCI-2013-02103: Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263) • omipalisib (GSK2126458)
    17d
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3, N=300, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    1m
    Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1, N=22, Terminated, National Cancer Institute (NCI) | Active, not recruiting --> Terminated; Drug supply issues
    Trial termination • Combination therapy • Surgery • Metastases
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • onalespib (AT13387)
    7ms
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    9ms
    First NGS-based companion diagnostic to aid in the selection of targeted therapy for anaplastic thyroid cancer patients with BRAF V600E mutations (AACR 2024)
    On September 29, 2023, the FDA granted companion diagnostic approval to the Oncomineâ„¢ Dx Target Test (ODxT Test) as an aid in the selection of patients with BRAF V600E-mutated ATC who may be eligible for treatment with dabrafenib in combination with trametinib. The ODxT Test was shown to be effective in identifying BRAF V600E mutations in ATC patients through a clinical concordance study using specimens from patients enrolled in the ROAR trial and commercially-sourced samples. The results support the expanded indication to the ODxT Test and marks the first FDA-approved NGS-based companion diagnostic for patients with BRAF V600E-mutated ATC.
    Clinical • Next-generation sequencing • Companion diagnostic
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600
    |
    THXID® BRAF Kit • Oncomine™ Dx Target Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib)
    11ms
    NCI-2013-02103: Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PTEN (Phosphatase and tensin homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    BRAF V600E • BRAF mutation • BRAF V600 • PTEN mutation • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)
    12ms
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Oct 2024 --> Jun 2024 | Trial primary completion date: Oct 2024 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    1year
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    almost2years
    Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)
    2years
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Oct 2022 --> Oct 2023
    Trial completion date • Trial primary completion date
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib)
    over2years
    Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)