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[Anonymity of gamete donation and genetic testing].

July 5, 2020 dna 0
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[Anonymity of gamete donation and genetic testing].

Gynecol Obstet Fertil Senol. 2020 Jun 18;:

Authors: Neyroud AS, Roche M, Domin M, Jaillard S, Ravel C

Abstract
Development of genetic testing direct-to-consumer (DTC) for recreational purposes, although prohibited in France, is a real challenge to the current practice of gamete donation. Indeed, anonymity is a fundamental principle contributing to the ethics of donation. This principle is weakened due to the availability to the general public of these tests on the Internet. Several thousands of people are conceived by gamete donation worldwide, some of whom do not know how they were conceived. Gamete donors should be informed that their anonymity is no longer guaranteed, as they can be found by homologies of their DNA, or that of a parent or a child, potentially available in databases. Thus, adults conceived by gamete donation but not informed by their parents can discover their way of conception. Recipients of gamete donation should also be informed that their child’s DNA will establish the biological discrepancy and they should be encouraged to disclose the conception to their child. Several countries now allow children conceived by donation to obtain donor’s identity. In France, the Bioethics Law is currently being finalized and will now allow access to donor’s identity for people conceived by gamete donation.

PMID: 32565387 [PubMed – as supplied by publisher]

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Who’s on third? Regulation of third-party genetic interpretation services.

June 21, 2020 dna 0
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Who’s on third? Regulation of third-party genetic interpretation services.

Genet Med. 2020 01;22(1):4-11

Authors: Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL

Abstract
In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services’ Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

PMID: 31402353 [PubMed – indexed for MEDLINE]

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Who’s on third? Regulation of third-party genetic interpretation services.

June 19, 2020 dna 0
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Who’s on third? Regulation of third-party genetic interpretation services.

Genet Med. 2020 01;22(1):4-11

Authors: Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL

Abstract
In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services’ Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

PMID: 31402353 [PubMed – indexed for MEDLINE]

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Who’s on third? Regulation of third-party genetic interpretation services.

June 19, 2020 dna 0
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Who’s on third? Regulation of third-party genetic interpretation services.

Genet Med. 2020 01;22(1):4-11

Authors: Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL

Abstract
In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services’ Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

PMID: 31402353 [PubMed – indexed for MEDLINE]

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Who’s on third? Regulation of third-party genetic interpretation services.

June 17, 2020 dna 0
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Who’s on third? Regulation of third-party genetic interpretation services.

Genet Med. 2020 01;22(1):4-11

Authors: Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL

Abstract
In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services’ Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

PMID: 31402353 [PubMed – indexed for MEDLINE]

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Who’s on third? Regulation of third-party genetic interpretation services.

June 15, 2020 dna 0
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Who’s on third? Regulation of third-party genetic interpretation services.

Genet Med. 2020 01;22(1):4-11

Authors: Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL

Abstract
In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services’ Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

PMID: 31402353 [PubMed – indexed for MEDLINE]

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Who’s on third? Regulation of third-party genetic interpretation services.

June 13, 2020 dna 0
Icon for Nature Publishing Group Related Articles

Who’s on third? Regulation of third-party genetic interpretation services.

Genet Med. 2020 01;22(1):4-11

Authors: Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL

Abstract
In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services’ Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

PMID: 31402353 [PubMed – indexed for MEDLINE]

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[Direct-to-consumer genetic tests in the consulting room].

June 5, 2020 dna 0
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[Direct-to-consumer genetic tests in the consulting room].

Ned Tijdschr Geneeskd. 2019 11 28;163:

Authors: Gerrits EM, van Dooren MF, Bredenoord AL, van Mil MHW

Abstract
Rapid developments in genome technology and a growing interest in personalized healthcare have led to a large rise in the range and use of commercial DNA tests, the so-called direct-to-consumer genetic tests (DTC-GT). DTC-GT can be of a non-medical (e.g. for external characteristics) or medical nature; medical tests mostly indicate relative risks of disease e.g. Alzheimer’s disease or certain forms of cancer. Low clinical validity and frequently unknown analytical validity of DTC-GT make it difficult to estimate the clinical usefulness of test results. From an ethical perspective, an increase in autonomy and possible health benefits must be weighed against loss of privacy, inadequate provision of information and the risk of misinterpretation of results, over-diagnosis, overtreatment and higher healthcare costs. It is unclear whether providing and implementing DTC-GT require authorisation under Dutch law in the Population Screening Act (Wet op het Bevolkingsonderzoek) or the Special Medical Procedures Act (Wet op BijzondereMedischeVerrichtingen). Clinical utility of DTC-GT can only increase if there is greater clarity on interpretation and scope of the law and regulations, when DTC-GT companies provide better information and guidance for consumers and when there is more focus on DTC-GT in education and training programmes for healthcare professionals.

PMID: 32073784 [PubMed – indexed for MEDLINE]

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Information Provided to Consumers about Direct-to-Consumer Nutrigenetic Testing.

May 27, 2020 dna 0
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Information Provided to Consumers about Direct-to-Consumer Nutrigenetic Testing.

Public Health Genomics. 2019;22(5-6):162-173

Authors: De S, Pietilä AM, Iso-Touru T, Hopia A, Tahvonen R, Vähäkangas K

Abstract
BACKGROUND: Nutrigenetic tests are often considered to be less serious compared to other health-related genetic tests, although they share similar ethical concerns. Nutrigenetic tests are mainly available through direct-to-consumer genetic testing (DTC GT) and increasing in popularity.
OBJECTIVE: To analyze the contents of nutrigenetic DTC GT websites with respect to the adequacy of the information provided to support a well-informed decision of purchasing the tests.
METHODS: The websites of DTC GT companies selling nutrigenetic tests that could be ordered online without involving any healthcare professional, available in English, marketing tests in Europe, the USA, Australia, or Canada, and accessible from Finland were included in the study (n = 38). Quantitative and qualitative content analyses of the websites were carried out with the help of a codebook.
RESULTS: Of the 38 websites, 8 included a clearly identifiable and easy-to-find information section about genetics. The quality and contents of these sections were often insufficient and/or misleading. Fourteen websites had specific sections discussing the risks related to GT, and on 13 signed informed consent was requested for GT. Furthermore, only 2 of the companies offered any kind of pretest consultation and 13 offered mostly separately charged posttest consultation. The complex structure of the websites made it difficult to find all key information, with many important aspects buried in legal documents, which were challenging to comprehend even for a professional.
CONCLUSION: The structure of the websites and the amount and quality of the content therein do not support a well-informed decision.

PMID: 31779000 [PubMed – indexed for MEDLINE]