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TEST:
THXID® BRAF Kit

Company:
bioMérieux
Type:
FDA Approved
23d
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 Oncomine™ 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
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600
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THXID® BRAF Kit • Oncomine™ Dx Target Test
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Mekinist (trametinib) • Tafinlar (dabrafenib)
3ms
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
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PTEN (Phosphatase and tensin homolog) • BCL2 (B-cell CLL/lymphoma 2)
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BRAF V600E • BRAF mutation • BRAF V600 • PTEN mutation • BRAF V600K
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THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
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Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)
4ms
Trial completion date • Trial primary completion date • Metastases
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BRAF mutation • BRAF V600
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THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
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Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
6ms
Trial completion date • Trial primary completion date • Metastases
|
BRAF mutation • BRAF V600
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THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
|
Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
1year
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)
over1year
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)
almost2years
Enrollment closed
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BCL2 (B-cell CLL/lymphoma 2)
|
BRAF V600E • BRAF V600 • BRAF V600K
|
THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
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Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)