The ability to access and collate family records from various sources has spawned growing interest in genealogy.
The emergence of affordable and accessible ancestry DNA testing has made the research even more fascinating for amateur and professional genealogists.
The Science behind Genealogical DNA Testing Ancestry DNA testing aims to compare a person's genome to others from the presumed lineage, ethnic groups or location-specific groupings.
These results are not typically used for medical purposes such as determining gene-linked diseases and disorders; different tests are used for that purpose.
Collection of DNA material is a self-administered procedure using a kit provided by a DNA testing laboratory.
The test involves collection of DNA samples through inner cheek scrapings, also known as buccal swabs, which are then packaged and sent to a laboratory.
The testing laboratories may also provide storage services so that the sample is preserved for future testing and reference.
Ethnic markers in the DNA material are compared to a database to identify genetic connections of an individual up to 50 generations back.
Autosomal markers may be used to trace the current and possible locations where testers may find others with the same markers.
FDA Regulation of DNA Tests The U.
S.
Food and Drug Administration (FDA) is tasked with ensuring public safety by ensuring that all products designed for diagnosis, management and prevention of human conditions meet certain standards.
These products include diagnostic and therapeutic devices.
The Federal Food, Drug and Cosmetic Act provided the FDA with broad powers to regulate genetic test kits as medical devices.
However, regulation will depend on the way the test is marketed.
Commercial test kits may include the set of reagents needed to run DNA tests and which are sold to other laboratories.
LDT or laboratory-developed tests refer to those genetic tests developed and processed by the same laboratory.
Kits are strictly regulated by the FDA while LDTs are subject to discretionary regulation.
FDA oversight of genetic tests depends on the intended use of the device and risks involved should the tests yield inaccurate results.
Devices are classified into groups starting with class I devices that are considered low risk and receive the least scrutiny while class III device are subject to more stringent review.
Contamination and Accuracy of Genetic Tests The likelihood of contaminating samples for genetic testing is reduced when the tester adheres to guidelines for collecting, storing and transporting DNA samples.
Given the minute sample being tested, contaminants can affect the accuracy of results.
Recently, the FDA sought to stop a DNA testing company promoting and distributing its DNA test kit to consumers.
The FDA expressed concern that the company was unable to present proof of the accuracy of its Personal Genome Service, which appeared to be used more for determining genetic disease markers and less for ancestral DNA profiling.
Would you like to find out more about yourself and your family ancestry? Click here.
The emergence of affordable and accessible ancestry DNA testing has made the research even more fascinating for amateur and professional genealogists.
The Science behind Genealogical DNA Testing Ancestry DNA testing aims to compare a person's genome to others from the presumed lineage, ethnic groups or location-specific groupings.
These results are not typically used for medical purposes such as determining gene-linked diseases and disorders; different tests are used for that purpose.
Collection of DNA material is a self-administered procedure using a kit provided by a DNA testing laboratory.
The test involves collection of DNA samples through inner cheek scrapings, also known as buccal swabs, which are then packaged and sent to a laboratory.
The testing laboratories may also provide storage services so that the sample is preserved for future testing and reference.
Ethnic markers in the DNA material are compared to a database to identify genetic connections of an individual up to 50 generations back.
Autosomal markers may be used to trace the current and possible locations where testers may find others with the same markers.
FDA Regulation of DNA Tests The U.
S.
Food and Drug Administration (FDA) is tasked with ensuring public safety by ensuring that all products designed for diagnosis, management and prevention of human conditions meet certain standards.
These products include diagnostic and therapeutic devices.
The Federal Food, Drug and Cosmetic Act provided the FDA with broad powers to regulate genetic test kits as medical devices.
However, regulation will depend on the way the test is marketed.
Commercial test kits may include the set of reagents needed to run DNA tests and which are sold to other laboratories.
LDT or laboratory-developed tests refer to those genetic tests developed and processed by the same laboratory.
Kits are strictly regulated by the FDA while LDTs are subject to discretionary regulation.
FDA oversight of genetic tests depends on the intended use of the device and risks involved should the tests yield inaccurate results.
Devices are classified into groups starting with class I devices that are considered low risk and receive the least scrutiny while class III device are subject to more stringent review.
Contamination and Accuracy of Genetic Tests The likelihood of contaminating samples for genetic testing is reduced when the tester adheres to guidelines for collecting, storing and transporting DNA samples.
Given the minute sample being tested, contaminants can affect the accuracy of results.
Recently, the FDA sought to stop a DNA testing company promoting and distributing its DNA test kit to consumers.
The FDA expressed concern that the company was unable to present proof of the accuracy of its Personal Genome Service, which appeared to be used more for determining genetic disease markers and less for ancestral DNA profiling.
Would you like to find out more about yourself and your family ancestry? Click here.
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