In Guito’s article “Why is this $99 Home DNA Kit causing such an uproar?”, the author attempts to explain the reasoning behind the FDA stepping in to regulate 23andMe’s Home DNA Kits as medical device (2014). FDA had stepped in before with similar DNA mapping products due to the possibility of consumer misunderstanding of the results and of the manufacturer misinterpreting the findings. It is the FDA’s contention that their concern is for the safety of the general public and nothing more. According to Guito, there are many medical professionals who are in favor of consumer knowledge of their genetic profile as an effective means of health care and just as many who deem Home DNA Kits as useless information that could possibly cause anxiety and harm to them (2014). Conversely, another concern the FDA voices is the incompleteness of the results which can potentially harm consumers with false information and hope. In the end, Guito determines that FDA regulation is useful but the better service would be to develop a DNA Kit that is proven accurate and thereby useful to both consumer and medical professionals (2014).Guinto offers two examples of consumers who used the DNA Kits results to plan their health futures. The first was couple who used the results to determine what medical issues their children might face. The Abramse’s chose to do the Home DNA Kits as a cute nerdy gift idea and ended up using the findings to inform their doctors of possible health issues for each other and for their unborn children (2014). The results confirmed the wife’s celiac disease diagnosis and showed the possibility of her manifesting MS. This allowed the Abramses to begin preventative measures while pregnant with their first child.
The second example used was actress Angelina Jolie who used genetic testing to help her decide to have a double mastectomy and hysterectomy to prevent breast and cervical cancer (2014). Ms. Jolie’s mother had died from cervical cancer and Angelina’s DNA results showed she had the same genetic markers that predisposed her for developing breast and uterine cancers. She elected to have preventative surgeries even though her doctors determined she had an 87% chance of developing breast cancer. In both cases, the individuals used their DNA results to plan their medical/health futures (2014). Obviously, knowing what diseases or illnesses you are predisposed of developing is a huge asset to anyone because it allows you the option to utilize preventative medicine to circumvent possible life-threatening issues.
Ethical concerns about mapping your entire genome arise concerning right to privacy issues, information selling, incorrect results, misunderstanding the findings, and the security of the database housing the results. Ideally, the FDA regulation should place a firm control over these concerns, but no system is foolproof or safe from computer hackers who could hold your results “hostage” for unethical gains. Additionally, inaccurate genome sequencing could harm or maim individuals who have unnecessary elective surgery to prevent the development of a disease whose markers were erroneously found in results. Many medical professionals are not well versed on all aspects of whole genome sequencing and could feasibly perform preventative operations due to incorrect DNA results (2014).
Consequently, although Home DNA Kits appear to have a place in the medical health arena for both the consumer as well as health care providers, the technology is still not there to offer accurate, measurable, and fool proof results. Whole genome sequencing is in its’ infancy with a huge swath of information still not understood by researchers and medical professionals. Therefore, any Home DNA Kit results should be viewed as a cute nerdy gift idea rather than serve as a guide for medical concerns and prevention therapies.

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  • Guinto, J. (2014). Why is This $99 Home DNA Kit Causing Such an Uproar? Retrieved from