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Results for “direct-to-consumer genetic testing”

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At least 19 recordsLinked to original sources
PubMed2002

Limitations of direct-to-consumer advertising for clinical genetic testing.

Although direct-to-consumer (DTC) advertisements for pharmaceuticals have been appearing in the mass media for 20 years, DTC advertisements for genetic testing have only recently appeared. Advertisements for genetic testing can provide both consumers and physicians with information about test availability in an expanding market. However, 3 factors limit the value and appropriateness of advertisements: complex information, a complicated social context surrounding genetics, and a lack of consensus about the clinical utility of some tests. Consideration of several advertisements suggests that they overstate the value of genetic testing for consumers' clinical care. Furthermore, advertisements may provide misinformation about genetics, exaggerate consumers' risks, endorse a deterministic relationship between genes and disease, and reinforce associations between diseases and ethnic groups. Advertising motivated by factors other than evidence of the clinical value of genetic tests can manipulate consumers' behavior by exploiting their fears and worries. At this time, DTC advertisements are inappropriate, given the public's limited sophistication regarding genetics and the lack of comprehensive premarket review of tests or oversight of advertisement content. Existing Federal Trade Commission and Food and Drug Administration regulations for other types of health-related advertising should be applied to advertisements for genetic tests.

Advertising↗
PubMed2026

A Scoping Review of Direct-to-Consumer Nutrigenetic Testing: Mapping Genes and Associated Nutrition Recommendations.

Consumer demand for autonomy in their own health care is fueling the rise of personal genetic testing. Nutrigenetics tests promise tailored dietary recommendations to help consumers achieve their health and well-being goals. To support informed decision-making by both practitioners and consumers, there is a need for a comprehensive evaluation of the current market landscape and the specific nutrition claims being made. A scoping review was completed via an internet search. Companies that provided direct-to-consumer tests with nutritional recommendations were included. Nonhuman, or pediatric tests, and tests requiring a health practitioner to order were excluded. Genes and nutrition recommendations used in the testing panels were mapped, and company characteristics were summarized. The review was prospectively registered with Open Science Framework (DOI: 10.17605/OSF.IO/A4K2R). There were 104 companies providing 204 nutrition-related testing panels that were included. The mean cost was US$234, with North America the most common continent of company registration. Only 56 (54%) companies publicly disclosed the genes used to make nutritional recommendations, with 3309 unique genes identified across testing panels. Micronutrients (n = 1593 genes), cardiovascular health (n = 1446 genes), and weight loss (n = 1383 genes) were the most commonly reported nutrition categories. Posttest support was provided by 55 (53%) companies, but this was often at additional cost (n = 33), and the qualifications of those providing support varied greatly. The expanding nutrigenetics market continues to be unregulated, with high variability in offerings. With thousands of unique genes linked with nutrition recommendations, it is challenging for healthcare practitioners and consumers to keep pace with this dynamic market. Evidence analysis and resources are required to support healthcare practitioners to provide consumers with evidence-based guidance and ensure their best interests are protected.

Humans↗
PubMed2001

Reading between the lines: direct-to-consumer advertising of genetic testing in the USA.

This article critiques an advertisement in a theatre playbill by a bio-technology company for its commercial test for the BRCA1 and BRCA2 genetic mutation, which may indicate a higher risk for breast and ovarian cancer. The advertisement targets a vulnerable audience attending a play about one woman's isolated and painful death from ovarian cancer. It promotes a product with incomplete and at times incorrect information, and it misguides women by suggesting that they contact the company directly about this test, rather than encouraging them to talk to their health care providers about genetic testing and their personal risk of breast cancer. In an era in which more genetic tests will be integrated into clinical practice, we can expect an increase in direct-to-consumer marketing for such tests. This advertisement is an example of what we need to be on guard against.

Advertising↗
PubMed2004

The impact of genomics on E-health.

The Human Genome Project (HGP) and e-Health are two fundamental changes that will alter the way we approach human health and life. These two scientific and societal forces will inevitably impact each other. This paper not only explores the ways that the HGP will change health care but also investigates the ways that e-Health systems will be influenced by the genomic data. The Electronic Medical Record (EMR) is discussed at length, including the probable impact on the laboratory, pharmacy, computerized provider order entry (CPOE), and other components. Thirteen points of a possible genomic future involving the EMR are presented. The genomic impact on other e-Health systems includes those at all levels of data: population, disease, patient, tissue and organ banks, cellular and for specific genes. The genomic impact on consumer health systems is explored, including Internet consumer information resources and the movement for direct-to-consumer genetic testing. The paper concludes that technology and trends of e-Health will enable the upcoming revolution caused by the health implications of the research emanating from the Human Genome Project.

Delivery of Health Care↗
PubMed2004

Genetic testing for breast and ovarian cancer susceptibility: evaluating direct-to-consumer marketing--Atlanta, Denver, Raleigh-Durham, and Seattle, 2003.

Breast and ovarian cancer are the second and fifth leading causes of cancer death, respectively, among women in the United States. One in eight women will have breast cancer during their lifetimes, and one in 70 will have ovarian cancer. Mutations in two genes, BRCA1 and BRCA2 (BRCA1/2), are associated with predisposition for inherited breast and ovarian cancer and are identified in 5%-10% of women with breast or ovarian cancer (BOC). Since 1996, genetic testing for these mutations has been available clinically; however, population-based screening is not recommended because of the complexity of test interpretation and limited data on clinical validity and utility. Despite the test's limited applicability in the general population, the U.S. provider of clinical BRCA1/2 testing (Myriad Genetic Laboratories, Inc., Salt Lake City, Utah) conducted a pilot direct-to-consumer (DTC) marketing campaign in two cities (Atlanta, Georgia, and Denver, Colorado) during September 2002-February 2003. Although DTC advertisements have been used to raise consumer awareness about pharmaceuticals, this was the first time an established genetic test was marketed to the public. To assess the impact of the campaign on consumer behaviors and health-care provider practices, CDC and the respective state health departments for the pilot cities and two comparison cities (Raleigh-Durham, North Carolina, and Seattle, Washington) surveyed consumers and providers. This report summarizes results of those surveys, which indicated that consumer and provider awareness of BRCA1/2 testing increased in the pilot cities and that providers in these cities perceived an impact on their practice (e.g., more questions asked about testing, more BRCA1/2 tests requested, and more tests ordered). However, in all four cities, providers often lacked knowledge to advise patients about inherited BOC and testing. These findings underscore the need for evidence-based recommendations on appropriate use of genetic tests and education of providers and the public to achieve maximum individual and public health benefit from genetic testing.

Adult↗
PubMed2005

Impact of direct-to-consumer advertising for hereditary breast cancer testing on genetic services at a managed care organization: a naturally-occurring experiment.

PURPOSE: To describe the impact of Myriad Genetics, Inc.'s direct-to-consumer advertising (DTC-ad) campaign on cancer genetic services within two Managed Care Organizations, Kaiser Permanente Colorado (KPCO), Denver, Colorado, where the ad campaign occurred, and Henry Ford Health System (HFHS), Detroit, Michigan, where there were no advertisements. METHODS: The main outcome measures were the changes in number and pretest mutation probability of referrals approved for cancer genetic services at KPCO and HFHS during the campaign versus the year prior, and mutation probability of those undergoing testing. RESULTS: At KPCO, referrals increased 244% during the DTC-ad compared to the same time period a year earlier (P value<0.001). The proportion of referrals at high pretest probability of a mutation (10% or greater) dropped from 69% the previous year to 48% during the campaign (P value<0.001). There was no significant change in pretest mutation probability among women who underwent testing between the two time periods. HFHS reported no significant change between the two time periods for numbers or mutation probability of referrals, or for mutation probability of women tested. CONCLUSION: The DTC-ad caused significant increase in demand for cancer genetic services. In the face of potential future DTC-ad for inherited cancer risk, providers and payers need to consider the delivery of genetic services and genetic education for persons of all risk levels.

Adult↗
PubMedDate not supplied

Direct-to-consumer sales of genetic services on the Internet.

PURPOSE The increasing use of the Internet to obtain genetics information and to order medical services without a prescription, combined with a rise in direct-to-consumer marketing for genetic testing, suggests the potential for the Internet to be used to sell genetic services. METHODS A systematic World Wide Web search was conducted in May 2002 to assess the availability of genetic services sold directly to consumers on the Internet. RESULTS Out of 105 sites that offered genetic services directly, most offered non-health-related services, including parentage confirmation testing (83%), identity testing (56%), and DNA banking (24%); however, health-related genetic tests were offered through 14 sites (13%). The health-related genetic tests available ranged from standard tests, such as hemochromatosis and cystic fibrosis, to more unconventional tests related to nutrition, behavior, and aging. Of these 14 sites, 5 described risks associated with the genetic services and 6 described the availability of counseling. CONCLUSIONS The availability of direct sales of health-related genetic tests creates the potential for inadequate pretest decision making, misunderstanding test results, and access to tests of questionable clinical value.

Commerce↗
PubMed2003

Where there's a web, there's a way: commercial genetic testing and the Internet.

The Internet has become a "global marketplace", enabling consumers to purchase health care products and services, including genetic testing, through a variety of national and international sources. A web search for commercial (for-profit) genetic testing companies found 12 with a web presence that were offering adult genetic susceptibility testing, of which 3 offered direct-to-consumer access. In this paper, Canada--with its educated population and universal health care system--will serve as a case study for illustrating the social, ethical and policy issues (e.g., information privacy, just access to health care, product safety, and access to unbiased health information) arising with Internet-based access to commercial genetic testing. Health professionals, policy makers and consumers in all developed nations will be faced with complex technical, social and ethical issues, but without further discussion it will not be possible to determine how best to manage and maximise the benefits of this increased accessibility and choice, while minimising the associated personal and social costs.

Genetic Counseling↗
PubMed2016

Implications of Personal Genomic Testing for Health Behaviors: The Case of Smoking.

INTRODUCTION: Direct-to-consumer personal genomic testing has the potential to influence health behaviors, including smoking. Critics of this testing highlight limited evidence to support positive behavioral benefits and caution that genomic results may provide false reassurance, leading to unhealthy behaviors. This study investigates interest in genetic risks of smoking-related diseases and changes in smoking behaviors among genomic testing consumers. METHODS: From 2012 to 2013, a longitudinal series of web surveys was conducted. A total of 1464 customers of 23andMe and Pathway Genomics completed a survey prior to viewing genomic test results, of which 1002 participants provided data on smoking behaviors 6 months after receiving results. RESULTS: At baseline, 64% of participants were never smokers, 29% were former smokers, and 7% were current smokers. Most baseline current smokers were very interested in genetic risk results for lung cancer (65%) and heart disease (72%). For lung cancer, this interest was significantly greater than former (50% very interested) and never smokers (37% very interested) (p < .0001). Even though participants were interested in smoking-related disease genetic risks, 96% reported the same smoking status at baseline and 6-month follow-up. Importantly, only 1% (n = 13/916) of former and never smokers became current smokers at 6 months and 22% (n = 14/64) of current smokers reported quitting. CONCLUSIONS: Overall, smokers show a high level of interest in genetic risks of smoking-related illnesses. The experience of receiving direct-to-consumer genomic health risks does not appear to have obvious harms related to smoking behaviors, with some potential benefits. IMPLICATIONS: In the setting of ongoing controversy surrounding direct-to-consumer genomic testing, this study provides evidence that consumers are interested in genetic risk results of smoking-related diseases. Receiving genomic testing results does not lead to smoking initiation among never smokers or reinitiation among former smokers and may be associated with a higher quit rate among current smokers at 6-month follow-up than the general population. These findings ease concerns that direct-to-consumer genomic testing could lead to false reassurance and unhealthy behaviors related to smoking.

Adolescent↗