BCMAS 3 | BOARD CERTIFIED MEDICAL AFFAIRS SPECIALIST STUDY SET 3 PRACTICE
QUESTIONS & EXAM REVIEW 2026/2027
Pharmacogenomic information should be included in the labeling of a drug or biologic if it provides
information regarding - ✔✔-Efficacy and safety due to patient's genotype
-Dosing considerations made for certain patient subgroups
-Pharmacogenomic test that is required before initiating treatment
For a medical affairs professional, understanding diagnostics is important when it comes to (select all
that apply) - ✔✔Clinical Trial Design
Educating Practitioners
Medical Strategy
Which of the following would be an example of a "companion device"? (Select all that apply) - ✔✔-A
test that is required to exclude ineligible patients from the use of a specific biologic due to their
genotype
-A test that checks for a genetic mutation that increases the likelihood of adverse effects with a
particular drug
-An IVDD used to determine the genotype of the patient in which a drug is effectiv
Point-of-Care diagnostics are: - ✔✔Simple medical tests that may produce immediate results
Which of the following is an example of Molecular Diagnostics? - ✔✔HIV viral load testing
HPV Screening
CF carrier testing
True or False: In vitro diagnostics only require exterior tissues/fluids of the body (such as skin, sweat)? -
✔✔False
True or False. Pharmacogenetics is defined as the study of variations in DNA sequence as related to drug
response. - ✔✔True
Which of the following is considered "state-of-art" technology in in-vitro diagnostics arena? -
✔✔Molecular Diagnostics
What are the advantages of point-of-care diagnostics? - ✔✔Patient convenience
Faster decision making
Better compliance
Lower operational costs
The FDA requires special labeling for IVD products. This includes (Select all that apply) - ✔✔-Intended
uses
QUESTIONS & EXAM REVIEW 2026/2027
Pharmacogenomic information should be included in the labeling of a drug or biologic if it provides
information regarding - ✔✔-Efficacy and safety due to patient's genotype
-Dosing considerations made for certain patient subgroups
-Pharmacogenomic test that is required before initiating treatment
For a medical affairs professional, understanding diagnostics is important when it comes to (select all
that apply) - ✔✔Clinical Trial Design
Educating Practitioners
Medical Strategy
Which of the following would be an example of a "companion device"? (Select all that apply) - ✔✔-A
test that is required to exclude ineligible patients from the use of a specific biologic due to their
genotype
-A test that checks for a genetic mutation that increases the likelihood of adverse effects with a
particular drug
-An IVDD used to determine the genotype of the patient in which a drug is effectiv
Point-of-Care diagnostics are: - ✔✔Simple medical tests that may produce immediate results
Which of the following is an example of Molecular Diagnostics? - ✔✔HIV viral load testing
HPV Screening
CF carrier testing
True or False: In vitro diagnostics only require exterior tissues/fluids of the body (such as skin, sweat)? -
✔✔False
True or False. Pharmacogenetics is defined as the study of variations in DNA sequence as related to drug
response. - ✔✔True
Which of the following is considered "state-of-art" technology in in-vitro diagnostics arena? -
✔✔Molecular Diagnostics
What are the advantages of point-of-care diagnostics? - ✔✔Patient convenience
Faster decision making
Better compliance
Lower operational costs
The FDA requires special labeling for IVD products. This includes (Select all that apply) - ✔✔-Intended
uses
