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Ch. 22 - Applications of Genetic Engineering and Biotechnology
Klug - Concepts of Genetics  12th Edition
Klug12th EditionConcepts of Genetics ISBN: 9780135564776Not the one you use?Change textbook
Chapter 22, Problem 22

Private companies are offering personal DNA sequencing along with interpretation. What services do they offer? Do you think that these services should be regulated, and if so, in what way? Investigate one such company, 23andMe, at http://www.23andMe.com, before answering these questions.

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Research the services offered by 23andMe by visiting their website and reviewing their product offerings. Focus on identifying key services such as ancestry analysis, health risk reports, carrier status for genetic conditions, and wellness traits.
Understand the implications of personal DNA sequencing by considering the benefits, such as personalized health insights, and potential risks, such as privacy concerns and the accuracy of interpretations.
Evaluate the need for regulation by analyzing ethical concerns, including data security, informed consent, and the potential misuse of genetic information by third parties like insurance companies or employers.
Investigate existing regulations or guidelines for genetic testing companies, such as those provided by the FDA or other governing bodies, and assess whether these are sufficient to address the concerns identified.
Propose potential regulatory measures, such as stricter data protection laws, mandatory accuracy standards for genetic interpretations, and clear guidelines for consumer education about the limitations of genetic testing.

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Key Concepts

Here are the essential concepts you must grasp in order to answer the question correctly.

Personal DNA Sequencing

Personal DNA sequencing involves analyzing an individual's genetic material to identify variations in their DNA. This process can reveal information about ancestry, genetic predispositions to certain health conditions, and traits. Companies like 23andMe utilize advanced sequencing technologies to provide consumers with insights into their genetic makeup, which can inform health and lifestyle choices.
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Genetic Interpretation

Genetic interpretation refers to the analysis and explanation of the data obtained from DNA sequencing. This includes translating complex genetic information into understandable results, such as risk factors for diseases or inherited traits. Effective interpretation is crucial for consumers to make informed decisions about their health, but it also raises ethical concerns regarding privacy and the potential for misinterpretation.
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Regulation of Genetic Services

Regulation of genetic services involves establishing guidelines and standards to ensure the accuracy, privacy, and ethical use of genetic information. As personal DNA testing becomes more accessible, there is a growing debate about how to protect consumers from misleading information and potential misuse of their genetic data. Regulatory frameworks could include requirements for transparency, consent, and the qualifications of those interpreting genetic results.
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Related Practice
Textbook Question

Should the FDA regulate direct-to-consumer genetic tests, or should these tests be available as a 'buyer beware' product?

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Textbook Question

Would you have your genome sequenced, if the price was affordable? Why or why not? If you answered yes, would you make your genome sequence publicly available? How might such information be misused?

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Textbook Question

Following the tragic shooting of 20 children at a school in Newtown, Connecticut, in 2012, Connecticut's state medical examiner requested a full genetic analysis of the killer's genome. What do you think investigators might be looking for? What might they expect to find? Might this analysis lead to an oversimplified analysis of the cause of the tragedy?

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Textbook Question

Yeager, M., et al. [(2007) Nature Genetics 39:645–649] and Sladek, R., et al. [(2007) Nature 445:881–885] have used single-nucleotide polymorphisms (SNPs) in genome-wide association studies (GWAS) to identify novel risk loci for prostate cancer and Type 2 diabetes, respectively. Each study suggests that disease-risk genes can be identified that significantly contribute to the disease state. Given your understanding of such complex diseases, what would you determine as reasonable factors to consider when interpreting the results of GWAS?

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Textbook Question

In 2010, a U.S. District Judge ruled to invalidate Myriad Genetics' patents on the BRCA1 and BRCA2 genes. Judge Sweet noted that since the genes are part of the natural world, they are not patentable. Myriad Genetics also holds patents on the development of a direct-to-consumer test for the BRCA1 and BRCA2 genes.

Would you agree with the ruling to invalidate the patenting of the BRCA1 and BRCA2 genes? If you were asked to judge the patenting of the direct-to-consumer test for the BRCA1 and BRCA2 genes, how would you rule?

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Textbook Question

In 2010, a U.S. District Judge ruled to invalidate Myriad Genetics' patents on the BRCA1 and BRCA2 genes. Judge Sweet noted that since the genes are part of the natural world, they are not patentable. Myriad Genetics also holds patents on the development of a direct-to-consumer test for the BRCA1 and BRCA2 genes.

J. Craig Venter has filed a patent application for his 'first-ever human-made life form.' This patent is designed to cover the genome of M. genitalium. Would your ruling for Venter's 'organism' be different from the judge's ruling on patenting of the BRCA1 and BRCA2 genes?

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