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2 reasons for genetic testing
- 1. personal decision-making
- -ex- mating, pregnancy, life style
- 2. medical decision-making
- -ex- screening for PKU in infants
5 issues with genetic testing
- 1. regulatory oversight - disclosure issues, etc.
- 2. genetic profiling
- 3. privacy and confidentiality
- 4. genetic counseling
- 5. cost
there is a bad boy gene where men lacking a particular variant of a gene makes them loyal
TRUE. no freaking way. where do I find those men.
GINA stands for ?
that's our classmate's name!! BUT ... in this class it stands for - Genetic Information NON-discrimination Act of 2008
Genetic Information Non-discrimination Act of 2008 (GINA)
- 1) prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future
- 2) legislation also bars employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decision
the 2008 act of GINA is not protected as Protected Health Information (PHI) and therefore not protected under HIPAA privacy rules
FALSE. it's the opposite. otherwise it defeats the purpose of GINA.
- patient has the control
FDA oversight of genetic testing by doing what?
- 1. examine
- 2. test <--
- 3. validate
- -before being marketed ... provide results that are clinically relevant
tests developed and utilized by one clinical laboratory
"Home Brew" is regulated and tested by who?
- -regulated by CMS (under CLIA - Clinical Laboratory Improvement Amendments)
- -tested by FDA
- -costs $3460/test
- -a 21 gene expression test that predicts the likelihood of chemotherapy benefit and recurrence risk for early-stage breast cancer patients
- -used to determine if chemotherapy would be beneficial
- = too expensive and not always covered by insurance (but later on they were more persuaded by its results)
- a biomarker is a characteristics that is objectively measured and evaluated as an indicator of:
- 1. normal biologic processes
- 2. pathogenic processes (cancer/mutations) - test on a chip ... test cancer cells (colon/breast/prostate) ... check just one cell! single cell level for cancer! wow
- 3. pharmacologic response to therapeutic intervention
- -covers all of these
50% of the time the drugs don't work the way we expected
- pharmacology + genomics
- the study of how an individuals' genetic makeup affects the body's response to drugs
- -the idea of treating disease based on the identification of biomarkers associated with a drug's efficacy and toxicity
- -lower drug product development costs primarily through targeted clinical trials
- -higher yield rate, but smaller market (niche busters)
- -improved safety profile
- use genetic variations to develop safe and effective treatments for genetically defined sub-groups of patients
- -predict the appropriate dose of a drug
specialty pharmacy target 3 things
- 1. high tech
- 2. high cost
- 2. high touch