Assessment Review Flashcards
True or False; in metastatic lung cancer, the presence of an oncogenic driver mutation and use of targeted therapy increases survival compared with not having a driver mutation and/or being treated with standard of care
True
True or False; the FDA and NIH define a biomarker as an indicator of advanced/metastatic cancer
False
Which of the following biomarkers would answer the question: “What is the likelihood of response to a treatment?”
Diagnostic
Monitoring
Predictive
Prognostic
Predictive
The statement “Lung cancer is a heterogeneous disease” indicates that there are:
Multiple testing modalities to assess for biomarkers
Many disease drivers
A variety of ways to obtain tissue or liquid biopsies
Many disease drivers
Which statement is FALSE? The NCCN NSCLC guidelines recommend the use of liquid biopsy when:
The patient is not medically fit for invasive tissue sampling
There is insufficient tissue for molecular analysis and follow-up tissue-based analysis will be done if a genetic abnormality is not identified by liquid biopsy
The pathologist orders liquid biopsy to decrease turnaround
A tumor doesn’t shed sufficient DNA for detection
A tumor doesn’t shed sufficient DNA for detection
True or False; all actionable and emerging biomarkers, except PD-L1, can be tested with both tissue and liquid biopsy
True
All of the following testing modalities may be used to test for KRAS mutations EXCEPT:
FISH
PCR
Sanger Sequencing
NGS
FISH
True or False; an LDT is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory and has been approved for use by the FDA
False
True or False; a CDx is a test for a specific biomarker that was used in the pivotal clinical trial of a corresponding FDA-approved drug
True
True or False; the turnaround time for PCR is typically longer than NGS
False
True or False; PD-L1 testing can be performed by NGS
False
An actionable biomarker:
Identifies a population eligible for an FDA-approved targeted therapy
Is under investigation with the goal of identifying appropriate therapies for benefits
Should be tested only after the patient progresses on first-line therapy to guide the physician’s “action” of deciding upon subsequent therapy
Identifies a population eligible for an FDA-approved targeted therapy
Which of the following an “emerging” biomarker?
EGFR
ALK
BRAF V600E
KRAS G12C
KRAS G12C
Cell-free DNA (cfDNA) are DNA fragments released from normal and cancer cells following necrosis or apoptosis that circulate in bloodstream
True
Which of the following test methodologies allows for the simultaneous sequencing of millions of DNA fragments?
IHC
dPCR
NGS
IHC and NGS
NGS