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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
All textbooksKlug 12th EditionCh. 22 - Applications of Genetic Engineering and BiotechnologyProblem 19
Chapter 22, Problem 19

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

Verified step by step guidance
1
Understand the context of direct-to-consumer genetic tests: These are tests marketed directly to consumers that provide genetic information without necessarily involving healthcare professionals. Examples include ancestry analysis, health risk assessments, and carrier status for genetic conditions.
Consider the role of the FDA: The FDA (Food and Drug Administration) is responsible for ensuring the safety, efficacy, and accuracy of medical devices and tests. Regulation by the FDA would involve oversight to ensure that genetic tests provide reliable and scientifically validated results.
Evaluate the risks of 'buyer beware' products: Without regulation, consumers may receive inaccurate or misleading genetic information, which could lead to unnecessary anxiety, incorrect medical decisions, or misuse of the data.
Analyze the benefits of regulation: FDA oversight could ensure that genetic tests meet specific standards for accuracy and reliability, protecting consumers from potential harm and fostering trust in genetic testing technologies.
Consider ethical and practical implications: Reflect on the balance between consumer autonomy (allowing individuals to access genetic tests freely) and the need for safeguards to prevent misuse or harm. This involves weighing the importance of informed decision-making and the potential consequences of unregulated genetic testing.

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Key Concepts

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

Direct-to-Consumer Genetic Testing

Direct-to-consumer (DTC) genetic testing allows individuals to access their genetic information without the need for a healthcare provider. These tests can provide insights into ancestry, health risks, and traits, but they often lack comprehensive clinical validation. Understanding the implications of DTC testing is crucial, as results can influence personal health decisions and raise ethical concerns regarding privacy and data security.
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Regulatory Framework

The regulatory framework for genetic testing involves guidelines and policies that govern the safety, efficacy, and marketing of these tests. In the U.S., the FDA has the authority to regulate medical devices, including genetic tests, to ensure they meet certain standards. The debate over whether DTC tests should be regulated hinges on balancing consumer protection with the desire for accessible information.
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Informed Consent and Consumer Awareness

Informed consent is a fundamental principle in healthcare that ensures individuals understand the risks and benefits of a procedure or test before proceeding. In the context of DTC genetic testing, consumer awareness is vital, as individuals must comprehend the limitations of the tests and the potential implications of their results. This concept raises questions about whether consumers can make informed choices without regulatory oversight.
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Related Practice
Textbook Question

Dominant mutations can be categorized according to whether they increase or decrease the overall activity of a gene or gene product. Although a loss-of-function mutation (a mutation that inactivates the gene product) is usually recessive, for some genes, one dose of the normal gene product, encoded by the normal allele, is not sufficient to produce a normal phenotype. In this case, a loss-of-function mutation in the gene will be dominant, and the gene is said to be haploinsufficient. A second category of dominant mutation is the gain-of-function mutation, which results in a new activity or increased activity or expression of a gene or gene product. The gene therapy technique currently being used in clinical trials involves the 'addition' to somatic cells of a normal copy of a gene. In other words, a normal copy of the gene is inserted into the genome of the mutant somatic cell, but the mutated copy of the gene is not removed or replaced. Will this strategy work for either of the two aforementioned types of dominant mutations?

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Textbook Question

In 2013 the actress Angelina Jolie elected to have prophylactic double-mastectomy surgery to prevent breast cancer based on a positive test for mutation of the BRCA1 gene. What are some potential positive and negative consequences of this high-profile example of acting on the results of a genetic test?

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Textbook Question

The National Institutes of Health created the Genetic Testing Registry (GTR) to increase transparency by publicly sharing information about the utility of their tests, research for the general public, patients, health-care workers, genetic counselors, insurance companies, and others. The Registry is intended to provide better information to patients, but companies involved in genetic testing are not required to participate. Should company participation be mandatory? Why or why not? Explain your answers.

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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

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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