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Test code(s) 91919

This is an outdated version of this FAQ. It was effective 10/15/2014 to 11/17/2016.

The current version is available here.

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 cells. Sanger sequencing has a limit of about 20%.

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 most “actionable” genes that are frequently altered in solid tumors. A patient-specific report is generated in collaboration with 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. Thus, clinical decisions are better informed when mutation testing is more comprehensive. NGS technology is more efficient at simultaneously analyzing multiple genes. Cost is 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 Memorial Sloan Kettering Cancer Center affect the OncoVantage assay?

MSK is providing information that facilitates clinical interpretation of mutations detected in the OncoVantage test. MSK scientists and clinicians have reviewed the current understanding of the biology and the clinical significance of each mutation. They 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.

This FAQ is provided for informational purposes only and is not intended as medical advice. A clinician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.

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