2-3-25 Flashcards
PGx Testing and technologies lecture 6 (41 cards)
what are examples of FDA-approved PGx drug labels?
one gene-multiple drugs
one drug-multiple genes
one gene-multiple alleles
who performs PGx test?
CLIA (clinical laboratory improvement amendments of 1988) certified labs
what is the CLIA?
US federal regulatory standards that apply to all clinical laboratory testing performed on humans in the US, except clinical trials and basic research
how does a CLIA lab perform a PGx test?
through FDA-approved platform/technology
how can a person find a CLIA lab?
through the GTR (genetic testing registry)
how can enough information be collected for a PGx test?
work closely with the therapeutic team
discuss with the patient
understand the FDA labeling/CPIC guidelines
know the principle of technologies
how can an informed decision be made with a PGx test?
strength of the PGx information vs other factors
cost vs benefits
selection of technologies
what answers the question “how convincing”?
nature of PGx studies for discovering the marker
ex - sample size, design, replication
what answers the question of how effective?
evidence in applying the PGx in clinical practice
ex - genotype the patients first and test the outcome
what answers the question how important?
the overall impact of the genotype on the phenotype
ex. 20-90% in all drugs
what are 4 levels of PGx?
genetic testing required
genetic testing recommended
actionable PGx
informative PGx
what does actionable PGx mean?
drug label mentioned-you determine
what does informative PGx mean?
suggestive
how can you determine the clinical implications of PGx test?
by determining the strength between a PGx marker and a clinical consequence through the questions how convincing, effective, and important is it
why should PGx not be relied on alone?
other non-genetic factors are in play (age, gender, BMI, diet, supplement intake)
especially when there is a sign of dangerous adverse drug reactions
is PGx testing required for all related drugs?
NO
why do not all drugs need testing?
do not bring enough benefit with a value that is hard to determine
- many test are not covered by insurance
- severe toxicity for many drugs is rare
- few patients may benefit from the test
- should consider when PGx information is already available
what is an example of a drug that PGx testing should occur with?
warfarin
information already available
how should it be determined if a PGx should be taken?
know the strengths and limitations of different methods
balance the cost and the information you need
what allele may be more important for African descendants?
CYP2C9*5-11
what are other important factors to be considered for genetic testing?
family history
race and ethnicity
vulnerable populations
consent/assent
why is family history an important factor to consider?
often indicates an involvement of genetic factors
example - patient has previous ADR or genetically related relatives
why is race and ethnicity important factor to be considered?
allele frequency/mutation rate can be very different between populations
example - CYP2C9
what are examples of vulnerable populations that need to be considered?
children
patients with diminished competence and/or decision-making capacity due to medical conditions
incomplete medical information
