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
- 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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OncoVantage®Test code(s) 91919
Question 1. What exactly is next generation sequencing (NGS) and what is special about the Quest Diagnostics OncoVantage assay?
NGS technologies use highly multiplexed sequencing to characterize millions of DNA base pairs simultaneously. NGS allows many exons from many genes to be interrogated using small amounts of patient specimen. Clinically relevant mutations can be detected when they occur in as little as 5% of the cells in tissues comprised of tumor and normal cells1. Sanger sequencing has a limit of about 20%2.
OncoVantage utilizes NGS technology to provide the most relevant and clinically useful mutation profile for solid tumors. These tumors include, but are not limited to, lung cancer, colorectal cancer, melanoma, gastrointestinal stromal tumors, breast cancer, thyroid cancer, ovarian cancer, pancreatic cancer, and prostate cancer.
The OncoVantage mutation profile includes the 34 “actionable” genes that are frequently altered in solid tumors. A patient-specific report is generated in collaboration with IBM Watson for Genomics and Memorial Sloan Kettering (MSK). It includes the mutations identified, their role in cancer, the drugs known to target the mutations, and the predicted responses to those drugs.
Question 2. Why perform NGS instead of a single gene mutation test?
Some tumors have multiple mutations, and interactions may occur between those mutations. A benefit of NGS technology is that it is more efficient at simultaneously analyzing multiple genes. For certain patients, performing a comprehensive mutation analysis may lead to more informed clinical decision making and cost may be reduced relative to that incurred when mutations are sought one by one.
Question 3. How were the 34 genes chosen for inclusion in the OncoVantage test, and how are results reported?
Inclusion of the 34 genes in the OncoVantage test was based on the gene’s role as a key target of, or predictive marker for, an anti-cancer drug. Selected genes may be a target of an FDA-approved drug or a new drug currently in development or a clinical trial. All the genes are considered clinically “actionable,” meaning knowledge that a patient has a mutation in the gene can be used to help determine the optimum treatment for an individual patient.
The patient report includes the mutation(s) identified, availability of FDA-approved drug(s) targeting the mutation(s), relevant clinical trials (phase III/IV mainly), and supporting information from national and international guidelines and peer-reviewed publications.
Question 4. If a mutation is detected, what does that mean to my patient?
Detection of a mutation indicates the presence of a potentially actionable therapeutic target for the patient. In certain situations, the absence of a mutation could also be actionable, and the OncoVantage report provides implications of this as well.
Be aware that OncoVantage results may overlap with available companion diagnostic tests. The therapeutic target may be one for which guideline-based indications exist. The guideline may be specific to a particular tumor type; however, the target may be actionable for another tumor type too. Choice of therapy for the individual patient is solely the responsibility of the physician, based on his/her clinical judgment.
Question 5. How does the partnership with IBM Watson for Genomics affect the OncoVantage assay?
Watson compares mutations found in the tumor against relevant medical literature, clinical studies, pharmacopeia and carefully annotated rules created by leading oncologists, including those from MSK. Watson for Genomics incorporates approximately 10,000 scientific articles and 100 new clinical trials every month. In addition to the data Watson uses, MSK will provide OncoKB, a database of clinical evidence that will help Watson describe how each mutation impacts potential therapeutic approaches and list potential FDA-approved drugs and candidate clinical trials. The final reported interpretation for each patient is written by a Quest Diagnostics Laboratory Director.
Question 6. Which specimen types are accepted?
The preferred specimen type is formalin-fixed, paraffin embedded (FFPE) tissue (tissue blocks or slides). Sections should contain adequate material (1 cm2) for DNA extraction. Tissue will be macro-dissected if necessary. Core needle biopsies are acceptable if sufficient tumor is present. Other sample types require prior approval from the Laboratory Director.
Question 7. Does your test cover exon 2 and nonexon 2 mutations in KRAS and NRAS?
OncoVantage detects mutations in exon 2 and other exons in both genes.
Question 8. What is the expected turnaround time?
The expected turnaround time after sample receipt is two weeks. It is essential that all of the required patient information is provided, especially tumor type, for adequate interpretation. Oncology client services will contact ordering sites to request missing information.
Question 9. Does the OncoVantage assay detect germline mutations?
The OncoVantage v1.0 assay was not designed to detect germline mutations, as only hot spot regions for somatic mutations are sequenced. For information about germline mutation testing, please call a Quest Diagnostics Genetic Counselor at 866.GENE.INFO.
- Data on file at Quest Diagnostics.
Tsiatis AC, Norris-Kirby A, Rich RG, et al. Comparison of Sanger sequencing, pyrosequencing, and melting curve analysis for the detection of KRAS mutations: diagnostic and clinical implications. J Mol Diagn. 2010;12:425-432.