Which of the following is defined as, "the study of variations of DNA and RNA characteristics as related
to drug response"? - Pharmacogenomics
What must tests involve to be considered in vitro diagnostics? - Samples of tissue or body fluids
What are companion diagnostics? - A diagnostic test developed to provide information about a
corresponding drug.
What type of measurements are diagnostic tests providing to ensure accurate and reliable delivery of
information and data? - Objective and quantitative
What IVD market segment would Molecular Diagnostics belong to? - Technique
What is seen as a disadvantage of point-of-care (POC) diagnostics? - Training is required
What must the label of a companion diagnostic device contain information about? - The therapeutic
product for which it has been cleared/approved to be used with
A 5 year old has been brought to the pediatrician's office with symptoms of a fever, sore throat,
congestion, and cough that began 3 days ago. What type of in vitro diagnostic test would the physician
complete prior to prescribing medication? - Microbiology culture
In the design of successful clinical trials, all but which of the following would involve diagnostic tests? -
Market review criteria
Which type of IVDs are used in pharmacogenomics, biomarkers, rare and infectious diseases, and cancer
diagnostics? - · Molecular Diagnostics
What is an economic challenge that medical device manufacturers face? - Allowing the FDA to collect
user fees for pre-market approvals to improve the overall review process.
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