Test Your Knowledge

Question 1

Which of the following guidelines might clinicians reference to help them determine the most appropriate biomarkers and assays to use for biomarker testing in NSCLC?

NCCN
CAP/IASLC/AMP
ASCO
Any of the Above

Answer 1

Any of the Above

Question 2

True or False; Among patients with metastatic lung cancer, those who have an oncogenic driver and use targeted therapy tend to have improved survival compared with patients without a driver mutation who receive standard of care.

Answer 2

True

Question 3

In a large retrospective study of patients with metastatic NSCLC, it was determined that the median OS for patients with driver mutations who received first-line targeted therapy was approximately ___ that of patients who received first-line chemotherapy.

Answer 3

2.0 times

Question 4

The US Food and Drug Administration and NIH define a biomarker as a defined characteristic that is measured as an indicator of ___.

Normal biological processes
Pathogenic processes
Prenatal susceptibility to cancer
Biological responses to an exposure or intervention

Answer 4

All except prenatal susceptibly to cancer

Question 5

What type of biomarker is used to detect or confirm presence of a disease or condition of interest or to identify individuals with a subtype of the disease?

Answer 5

Diagnostic biomarker

Question 6

Which NSCLC biomarker is an immune checkpoint protein that inhibits T-cell activation?

Answer 6

PD-L1

Question 7

What is the approximate incidence of KRAS mutation in patients with NSCLC?

Answer 7

25 - 35%

Question 8

True or False; studies have shown that biomarker testing results from tissue biopsy or liquid biopsy have reasonable concordance across multiple biomarkers.

Answer 8

True

Question 9

Which of the following biomarker testing methods generally has the highest throughput?

IHC
Sanger sequencing
NGS
PCR

Answer 9

NGS

Question 10

True or False; In NSCLC, broad NGS panels can be used to detect all actionable biomarkers simultaneously, including EGFR, ALK, ROS1, NTRK, MET, REF, BRAF, and PD-L1, as well as several emerging biomarkers.

Answer 10

False; PD-L1 cannot be tested by a broad NGS panel

Question 11

True or False; KRAS mutations can be detected via single gene test or multigene test

Answer 11

True; single-gene test from Sanger sequencing or PCR or multigene using broad-panel NGS

Question 12

Which of the following biomarker testing methods detect only prespecified mutations of interest?

IHC
FISH
NGS
PCR

Answer 12

IHC
FISH
PCR

Question 13

True or False; Multiple companion diagnostic (CDx) tests have been FDA approved to test for KRAS mutations in patients with NSCLC

Answer 13

False

Question 14

Which of the following is the most common KRAS mutation in NSCLC?

G12A
G12C
G12D
G13D

Answer 14

G12C

Question 15

In NSCLC, KRAS mutations are usually considered to be ___ mutations, which means they occur early and likely ___ throughout the evolution of the tumor cells

Answer 15

Truncal; remain unchanged

Question 16

True or False; KRAS mutation favors the active form of the KRAS mutant protein, which supports tumor formation

Answer 16

True

Question 17

When is KRAS in its active state?

When it is bound to GDP
When it is bound to GTP
When it is bound to both GDP and GTP
When it is not bound to either GDP or GTP

Answer 17

When it is bound to GTP

Question 18

What proportion of KRAS mutations are KRAS G12C?

1/5th
1/4
~1/2
>2/3

Answer 18

1/2

Question 19

True or False; Biomarker testing is typically covered under the medical benefit.

Answer 19

True

Question 20

The Medicare NCD grants national coverage for NGS panels that are ___.

Answer 20

FDA approved

Question 21

True or False; The majority of KRAS G12C test are single-gene tests or non-FDA approved NGS panels, therefore, are governed by LCDs.

Answer 21

True

Question 22

The average patient OOP cost for Original Medicare is $__.

Answer 22

0

Question 23

__% of NSCLC patients are covered by Medicare for their biomarker tests.

Answer 23

73%

Question 24

___-codes are used predominantly by MoIDX for billing and reimbursement in conjunction with CPT codes

Answer 24

Z

Question 25

True or False; two types of CPT codes commonly used for biomarker tests are Category 1 codes and PLA codes.

Answer 25

True

Question 26

___ code is a type of CPT code with a corresponding descriptor for labs or manufacturers that want to more specifically identify their test.

Answer 26

PLA