Clinical Education Center
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- ABL Kinase Domain Mutation in CML, Cell-based
- ABO Group and Rh Type
- Acid-Fast Bacillus (AFB) Identification, Sequencing and Stain, Paraffin Block
- ADAMTS13 Activity with Reflex to ADAMTS13 Inhibitor
- Alcohol Metabolites, Quantitative, Urine
- Alpha-Globin Common Mutation Analysis
- Alpha-Globin Gene Deletion or Duplication
- Alpha-Globin Gene Sequencing
- Anti-Müllerian Hormone AssessR™
- Anti-PF4 and Serotonin Release Assay (SRA) for Diagnosing Heparin-induced Thrombocytopenia/Thrombosis (HIT/HITT)
- Antiphospholipid Antibodies
- ASCVD Risk Panel with Score
- Autoimmune Epilepsy Evaluation
- Autoimmune Diseases, Tests for
- B-cell and T-cell Clonality Assays by PCR
- B-Type Natriuretic Peptide (BNP)
- BCR-ABL1 Gene Rearrangement, Quantitative PCR
- Beta-Globin Complete
- BRCAvantage®, Ashkenazi Jewish Screen
- BRCAvantage®, Rearrangements
- BRCAvantage™, Comprehensive
- BRCAvantage™, Single Site
- CDH1 Sequencing and Deletion/Duplication
- Clostridium difficile Diagnostic Testing
- C1 Inhibitor, Protein and Functional Tests
- Calreticulin (CALR) Mutation Analysis
- Carbapenem Resistant Enterobacteriaceae Culture Screen
- Cardio IQ Lipoprotein Fractionation, Ion Mobility
- Cervical Cancer, TERC, FISH
- CFvantage® Cystic Fibrosis Expanded Screen
- Chlamydia trachomatis, TMA
- Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA
- Chromosomal Microarray, POC, ClariSure®, Oligo-SNP
- Chromosomal Microarray, Postnatal, ClariSure® Oligo-SNP
- Chromosome Analysis and AFP with Reflex to AChE, Fetal Hgb, Amniotic Fluid
- Chromosome Analysis, Amniotic Fluid
- Chromosome Analysis, Blood
- Chromosome Analysis, Blood with Reflex to Postnatal, ClariSure® Oligo-SNP Array
- Chromosome Analysis, Chorionic Villus Sample
- Chromosome Analysis, High Resolution
- Chromosome Analysis, High Resolution with Reflex to Postnatal, ClariSure® Oligo-SNP Array
- Chromosome Analysis, Mosaicism
- Chromosome Analysis, Neonatal Blood
- Chromosome Analysis, Sister Chromatid Exchange
- Chromosome Analysis, Tissue
- Chromosome DEB Assay for Fanconi anemia
- Chronic Lymphocytic Leukemia (CLL) - Diagnostic and Prognostic Testing
- Culture, Fungus
- Culture, Urine, Routine
- Cystic Fibrosis Screen
- Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) PCR
- D-Dimer, Quantitative
- Dementia, Secondary Causes
- Dengue Virus Testing
- Diabetes Risk Panel with Score and Cardio IQ® Diabetes Risk Panel with Score
- Drug Testing, General Toxicology (Blood, Urine, or Serum)
- Drug Toxicology Alcohol Metab, QN, Oral Fluid
- Drug Toxicology Monitoring, Oral Fluid Testing
- Factor V (Leiden) Mutation Analysis
- Familial Mediterranean Fever Mutation Analysis
- First Trimester Screen, hCG
- First Trimester Screen, Hyperglycosylated hCG (h-hCG)
- FISH, Angelman
- FISH, MET Amplification
- FISH, Myeloma, 17p-, rea 14q32 with Reflexes
- FISH, Prader-Willi
- FISH, Prenatal Screen
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- HCV Genotyping
- Helicobacter pylori (H pylori) Antibody Discontinuation
- Heparin, Anti-Xa
- Hepatitis B Surface Antibody, Quantitative
- Hepatitis C Antibody with Reflex to HCV RNA, PCR with Reflex to Genotype
- Hepatitis C Viral RNA Genotype 1 NS5A Drug-resistance
- Hepatitis C Viral RNA Genotype 3 NS5A Drug Resistance
- Hepatitis C Viral RNA NS3 Drug Resistance
- Hepatitis C, RNA, Quantitative, PCR
- Hereditary Cancer Panels: MYvantageTM Hereditary Comprehensive Cancer Panel and GIvantageTM Hereditary Colorectal Cancer Panel
- Hereditary Hemochromatosis DNA Mutation Analysis
- Herpes Simplex Virus (HSV) Type-Specific IgG Antibodies
- Herpes Simplex Virus Type 2 (HSV-2) IgG Inhibition, ELISA
- HIV-1 Coreceptor Tropism, Proviral DNA
- HIV-1 Coreceptor Tropism, Ultradeep Sequencing
- HIV-1 Integrase Genotype
- HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes
- HPV mRNA E6/E7
- Influenza A and B Antigen, Immunoassay
- Influenza Type A and B Antibodies
- Insulin, Intact, LC/MS/MS
- Integrated Screen, Part 1
- Integrated Screen, Part 2
- Intrinsic Factor Blocking Antibody
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- Maternal Serum AFP
- Melanoma, BRAF V600E and V600K Mutation Analysis, THxID®
- Metanephrines, Fractionated, Free, LC/MS/MS, Plasma
- Methylenetetrahydrofolate Reductase (MTHFR), DNA Analysis
- Microalbumin (Urinary Albumin Excretion)
- Pain Management and CYP2D6/CYP2C19
- Pain Management, Naltrexone, Quantitative, Urine
- Partial Thromboplastin Time, Activated (aPTT)
- Penta Screen
- PIK3CA Mutation Analysis
- Platelet Antibody Screen (Indirect)
- PNH with FLAER (High Sensitivity)
- Prothrombin Time with INR
- PTH, Intact and Calcium
- Streptococcus pneumoniae (Pneumococcal) Antibody Tests
- Saccharomyces cerevisiae Antibodies (ASCA) (IgG, IgA)
- Sequential Integrated Screen, Part 1
- Sequential Integrated Screen, Part 2
- Serum Integrated Screen, Part 1
- Serum Integrated Screen, Part 2
- Serum Pregnancy Tests
- Sickle Cell Screen
- Stepwise, Part 1
- Stepwise, Part 2
- SureSwab® Trichomonas vaginalis RNA, Qualitative TMA
- SureSwab®, Candidiasis, PCR
- TP53 Sequencing and Deletion/Duplication
- T4, Free
- Tamoxifen and Metabolites, LC-MS/MS
- Testosterone Testing
- Total Testosterone, LC/MS/MS
- Triple Screen
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Melanoma, BRAF V600E and V600K Mutation Analysis, THxID®Test code(s) 92131
Question 1. What is a companion diagnostic assay?
A companion diagnostic assay is an in vitro diagnostic (IVD) assay that provides information essential for the safe and effective use of a corresponding therapeutic drug.
The use of an IVD companion diagnostic assay with a particular therapeutic drug is stipulated in the instructions for use in the FDA labeling (package insert) of both the diagnostic assay and corresponding therapeutic drug.
A list of FDA cleared or approved companion diagnostic assays can be viewed on the following link:
Question 2. Is the bioMerieux THxID assay a companion diagnostic assay for all malignant melanoma therapies?
No. The FDA has approved two companion diagnostic assays to aid in treatment selection for a patient with malignant melanoma. These assays are designed to detect a specific BRAF mutation in formalin-fixed, paraffin embedded (FFPE) specimens.
- The bioMerieux THxID®-BRAF kit, which detects the codon 600 mutations V600E and V600K, serves as a companion diagnostic assay for Tafinlar® (dabrafenib) and/or Mekinist® (trametinib).
- The Roche Cobas®4800 BRAF V600 mutation test, which detects the V600E mutation and 50% of V600K mutations, is a companion diagnostic assay for Zelboraf® (vemurafenib).
Question 3. Which BRAF mutations does the bioMerieux THxID assay detect?
The bioMerieux THxID-BRAF is an IVD assay intended for the qualitative detection of BRAF V600E and V600K mutations in a DNA sample extracted from FFPE human melanoma tissue. It is a real-time PCR test performed on the ABI 7500 Fast Dx system and is labeled as a companion diagnostic device by the US FDA. Samples that are reported as BRAF mutation negative may harbor BRAF mutations not detected by the assay (for example V600R or V600D). Patients with V600R and V600D BRAF mutations have not been shown to be responsive to trametinib and or dabrafenib.
Approximately 50% of melanomas harbor activating BRAF mutations. Among the BRAF mutations observed in melanoma, over 90% are at codon 600, and, among these, over 90% are single nucleotide mutations resulting in substitution of glutamic acid for valine (BRAF V600E: nucleotide 1799 T>A; codon GTG>GAG). The second most common mutation is BRAF V600K (GTG>AAG), which substitutes lysine for valine; it accounts for 5% to 6% of melanoma BRAF mutations. Mutations occurring at lesser frequency include BRAF V600R (GTG>AGG), an infrequent two-nucleotide variation of the predominant mutation; BRAF V600 ′E2′ (GTG>GAA); and BRAF V600D (GTG>GAT).
Question 4. Which therapies are linked to the bioMerieux THxID assay?
The THxID-BRAF assay is intended to be used as an aid in selecting melanoma patients for treatment with Tafinlar®(dabrafenib). Patients eligible for treatment with dabrafenib test positive for the BRAF V600E mutation. The assay can also aid in the selection of melanoma patients for treatment with Mekinist® (trametinib).
Dabrafenib is a selective inhibitor of BRAF kinase activity, and trametinib is a selective inhibitor of MEK activity.
Question 5. Can any BRAF mutation assay serve as a companion diagnostic assay for targeted melanoma therapies?
No, only FDA cleared or approved assays can serve as companion diagnostic assays. Although non-FDA approved technologies, kits, or laboratory assays may identify the BRAF mutations of interest, they may not be used as a substitute for an FDA approved/cleared companion diagnostics assay for purposes of treatment selection.
Question 6. How can I differentiate an FDA cleared/approved BRAF assay from a non-FDA cleared/approved BRAF assay?
The FDA provides a list of approved or cleared companion diagnostics assays and their associated therapeutic agents.This list is available at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm .
Additionally, federal law requires laboratories to identify any non-FDA cleared or approved assays on the medical report.
Question 7. How is the Roche BRAF companion diagnostic assay different from the bioMerieux assay?
The Roche Cobas®4800 BRAF V600 companion diagnostic assay uses a different testing platform. It tests for BRAF V600 mutations but does not differentiate V600E from V600K. Results are reported as “mutation not detected” or “mutation detected.”
The bioMerieux THxID assay, on the other hand, tests for and distinguishes V600E and V600K mutations. The results are reported as “BRAF mutation negative,” “V600E mutation,” “V600K mutation,” or “V600E and V600K mutations.”
As indicated above, each of these tests is FDA approved only for a specific therapeutic agent(s).
Question 8. What other BRAF mutation assays do you offer?
16767: BRAF Mutation Analysis: Sanger sequencing method
90868: BRAF Mutation Analysis: allele-specific real-time PCR
90956: Melanoma, BRAF V600 Mutation, Cobas®: the Roche Cobas 4800 BRAF V600 test
91919: OncoVantage®: next generation sequencing panel for solid tumors
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