GENETIC TESTING AND ANALYSIS
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23andMe, Inc
Price: $429- health panel which includes carrier status, disease risk, drug metabolism
$399-ancestry only
$499- health panel+ancestry
*Additional fees for genetic counseling
Tests For: Ancestry, carrier status, disease risk, drug metabolism
Requires: Saliva
Roles of the Community
Genetic testing and analysis requires the combined effort of government agencies, biotech companies, and research universities.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) the FDA, CMS, and CDC regulate genetic testing in clinical laboratories. The FDA( Food and Drug Administration) categorizes the different types of genetic tests, regulates commercial test kits, and writes the regulations clinics must adhere to in order to perform the tests. The CMS (Center for Medicaid Services) enforces clinic regulations by performing inspections, develops regulations, and gives laboratory certificates to clinics. The CDC (Center for Disease Control) conducts research, approves of mandatory standards, and shares educational information to clinics. Below are additional examples of government regulatory agencies.
National Human Genome Research Institute (NHGRI) was responsible for the human genome project which was completed in April of 2003. NHGRI supports and funds technology to improve genomic research and hopes to integrate research findings into health care. NHGRI is still trying to resolve ethical issues surrounding genetic testing.
American Society of Human Genomics releases genetic information to the public as well as new research findings with health professionals.
KS&A is a non profit organization who serves those who inherit extra X and/ or Y chromosomes. Genetic diseases include Trisomy and Klinefelter Syndrome.
The Mount Sinai Center for Jewish Genetic Diseases serves the Jewish Community, a group well known to be susceptible to genetic disorders.
The National Society of Genetic Counselors(NSGC) consists of genetic counselors who aim to educate health professionals such as other genetic counselors to properly discuss the role of genetics to patients.
NCI is a part of the HHS (Health and Human Services) and is cancer research oriented.
