Editing Genetic testing (section)

==Direct-to-consumer genetic testing==
[[Direct-to-consumer advertising|Direct-to-consumer]] (DTC) genetic testing (also called at-home genetic testing) is a type of genetic test that is accessible directly to the consumer without having to go through a health care professional. Usually, to obtain a genetic test, health care professionals such as physicians, nurse practitioners, or [[Genetic counseling|genetic counselors]] acquire their patient's permission and then order the desired test, which may or may not be covered by health insurance. DTC genetic tests, however, allow consumers to bypass this process and purchase DNA tests themselves. DTC genetic testing can entail primarily genealogical/ancestry-related information, health and trait-related information, or both.<ref>{{Cite web|url=https://ghr.nlm.nih.gov/primer/dtcgenetictesting/directtoconsumer|title=What is direct-to-consumer genetic testing? | work = Genetics Home Reference | location = Bethesda (MD) | publisher = National Library of Medicine (US) |language=en|access-date=2019-10-03}}</ref> Genetic testing has been taken on by private companies, such as [[23andMe]], [[Ancestry.com]], and [[Family Tree DNA]]. These companies will send the consumer a kit at their home address, with which they will provide a saliva sample for their lab to analyze. The company will then send back the consumer's results in a few weeks, which is a breakdown of their ancestral heritage and possible health risks that accompany it.<ref>{{Cite web |date=2021-12-17 |title=At-home DNA test kits for 2022 {{!}} Medical News Today |url=https://www.medicalnewstoday.com/articles/at-home-dna-test-kits |access-date=2022-11-09 |website=www.medicalnewstoday.com |language=en}}</ref> 

There are a variety of DTC genetic tests, ranging from tests for breast cancer alleles to mutations linked to [[cystic fibrosis]]. Possible benefits of DTC genetic testing are the accessibility of tests to consumers, promotion of proactive healthcare, and the [[Genetic privacy|privacy of genetic information]]. Possible additional risks of DTC genetic testing are the lack of governmental regulation, the potential misinterpretation of genetic information, issues related to testing minors, [[Data privacy|privacy of data]], and downstream expenses for the public health care system.<ref>{{cite journal | vauthors = Borry P, Cornel MC, Howard HC | title = Where are you going, where have you been: a recent history of the direct-to-consumer genetic testing market | journal = Journal of Community Genetics | volume = 1 | issue = 3 | pages = 101–106 | date = September 2010 | pmid = 21475669 | pmc = 3063844 | doi = 10.1007/s12687-010-0023-z }}</ref> In the United States, most DTC genetic test kits are not reviewed by the [[Food and Drug Administration|Food and Drug Administration (FDA)]], with the exception of a few tests offered by the company [[23andMe]].<ref name="CDER_2018">{{Cite web | work = Center for Drug Evaluation and Research | publisher = U.S. Food and Drug Administration |date=2018-11-03|title=Direct-to-Consumer Tests|url=https://www.fda.gov/medical-devices/vitro-diagnostics/direct-consumer-tests |archive-url=https://web.archive.org/web/20190614212657/https://www.fda.gov/medical-devices/vitro-diagnostics/direct-consumer-tests |url-status=dead |archive-date=June 14, 2019 |language=en}}</ref> As of 2019, the tests that have received marketing authorization by the FDA include 23andMe's genetic health risk reports for select variants of [[BRCA mutation|BRCA1/BRCA2]],<ref>{{Cite news |url= https://www.washingtonpost.com/news/wonk/wp/2018/03/06/23andme-gets-fda-approval-to-report-breast-cancer-risk-without-a-doctor/|title=23andMe gets FDA approval to report breast cancer risk without a doctor| vauthors = Johnson CY |newspaper=Washington Post|language=en|access-date=2019-10-11}}</ref> [[Pharmacogenomics|pharmacogenetic]] reports that test for selected variants associated with metabolism of certain pharmaceutical compounds, a carrier screening test for [[Bloom syndrome]], and genetic health risk reports for a handful of other medical conditions, such as [[Coeliac disease|celiac disease]] and [[Alzheimer's disease|late-onset Alzheimer's]].<ref name="CDER_2018" />

===Controversy===
DTC genetic testing has been controversial due to outspoken opposition within the medical community. Critics of DTC genetic testing argue against the risks involved in several steps of the testing process, such as the unregulated advertising and [[marketing claim]]s, the potential reselling of genetic data to third parties, and the overall lack of governmental oversight.<ref name="pmid18494080">{{cite journal | vauthors = Audeh MW | title = Letting the genome out of the bottle | journal = The New England Journal of Medicine | volume = 358 | issue = 20 | pages = 2184–5; author reply 2185 | date = May 2008 | pmid = 18494080 | doi = 10.1056/nejmc086053 }}</ref><ref name="pmid18184955">{{cite journal | vauthors = Hunter DJ, Khoury MJ, Drazen JM | title = Letting the genome out of the bottle--will we get our wish? | journal = The New England Journal of Medicine | volume = 358 | issue = 2 | pages = 105–107 | date = January 2008 | pmid = 18184955 | doi = 10.1056/NEJMp0708162 }}</ref><ref>{{cite journal | vauthors = Thiebes S, Toussaint PA, Ju J, Ahn JH, Lyytinen K, Sunyaev A | title = Valuable Genomes: Taxonomy and Archetypes of Business Models in Direct-to-Consumer Genetic Testing | journal = Journal of Medical Internet Research | volume = 22 | issue = 1 | pages = e14890 | date = January 2020 | pmid = 31961329 | pmc = 7001042 | doi = 10.2196/14890 | doi-access = free }}</ref><ref>{{Cite journal |last1=Onstwedder |first1=Suzanne Maria |last2=Jansen |first2=Marleen Elizabeth |last3=Cornel |first3=Martina Cornelia |last4=Rigter |first4=Tessel |date=2024-07-17 |title=Policy Guidance for Direct-to-Consumer Genetic Testing Services: Framework Development Study |url=https://www.jmir.org/2024/1/e47389 |journal=Journal of Medical Internet Research |language=en |volume=26 |pages=e47389 |doi=10.2196/47389 |doi-access=free |pmid=39018558 |issn=1438-8871|pmc=11292153 }}</ref>

DTC genetic testing involves many of the same risks associated with any genetic test. One of the more obvious and dangerous of these is the possibility of misreading of test results. Without professional guidance, consumers can potentially misinterpret genetic information, causing them to be deluded about their personal health.

Some advertising for DTC genetic testing has been criticized as conveying an exaggerated and inaccurate message about the connection between genetic information and disease risk, utilizing emotions as a selling factor. An advertisement for a [[BRCA mutation|BRCA]]-predictive genetic test for breast cancer stated: "There is no stronger antidote for fear than information."<ref>Gollust et al., [http://jama.ama-assn.org/cgi/content/full/288/14/1762#REF-JSC20258-14 "Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing,"] JAMA.2002; 288: 1762-1767</ref> Apart from rare diseases that are directly caused by specific, single-gene mutation, diseases "have complicated, multiple genetic links that interact strongly with personal environment, lifestyle, and behavior."<ref>{{cite magazine | vauthors = Nisbet MC |date=2019 |title=DNA Is Not Destiny: Challenging the Hype over Genetic Testing |magazine=[[Skeptical Inquirer]] |volume=43 |issue=4 |pages=28–30}}</ref>

[[Ancestry.com]], a company providing DTC DNA tests for [[genealogy]] purposes, has reportedly allowed the [[warrantless search]] of their database by police investigating a murder.<ref>Ronald Bailey, [http://reason.com/blog/2015/05/06/ancestrycom-hands-over-client-dna-test-r " Ancestry.com Hands Over Client DNA Test Results to Cops Without a Warrant"] Reason.com</ref> The warrantless search led to a search warrant to force the gathering of a DNA sample from a New Orleans filmmaker; however he turned out not to be a match for the suspected killer.<ref>{{cite web | author = Jim Mustian | url = http://www.theneworleansadvocate.com/news/11707192-123/new-orleans-filmmaker-cleared-in | title = New Orleans filmmaker cleared in cold-case murder; false positive highlights limitations of familial DNA searching | work = The New Orleans Advocate | access-date = 2015-05-06 | archive-date = 2016-07-11 | archive-url = https://web.archive.org/web/20160711001920/http://www.theneworleansadvocate.com/news/11707192-123/new-orleans-filmmaker-cleared-in | url-status = dead }}</ref>