Direct-to-consumer personal genomic tests need better regulation

Osman Moneer; Jennifer E. Miller; Nilay D. Shah; Joseph S. Ross

doi:10.1038/s41591-021-01368-9

Direct-to-consumer personal genomic tests need better regulation

Osman Moneer, Jennifer E. Miller, Nilay D. Shah, Joseph S. Ross

Quantitative Health Sciences

Research output: Contribution to journal › Comment/debate › peer-review

Original language	English (US)
Pages (from-to)	940-943
Number of pages	4
Journal	Nature Medicine
Volume	27
Issue number	6
DOIs	https://doi.org/10.1038/s41591-021-01368-9
State	Published - Jun 2021

ASJC Scopus subject areas

Biochemistry, Genetics and Molecular Biology(all)

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10.1038/s41591-021-01368-9

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@article{411f8c9b55ab4a618edac036126b603c,

title = "Direct-to-consumer personal genomic tests need better regulation",

author = "Osman Moneer and Miller, {Jennifer E.} and Shah, {Nilay D.} and Ross, {Joseph S.}",

note = "Funding Information: J.E.M. and J.S.R. receive research support through Yale University from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International. N.D.S. has received research support through Mayo Clinic from the Food and Drug Administration to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative; the Agency for Healthcare Research and Quality (R01HS025164, R01HS025402, R03HS025517 and K12HS026379); the National Heart, Lung and Blood Institute of the US National Institutes of Health (R56HL130496, R01HL131535 and R01HL151662); the National Science Foundation; and the Patient Centered Outcomes Research Institute to develop a Clinical Data Research Network (LHSNet). J.S.R. has received research support through Yale University from the Laura and John Arnold Foundation for the Collaboration for Research Integrity and Transparency at Yale; and receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale–Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); from the Agency for Healthcare Research and Quality (R01HS022882), and from the National Heart, Lung and Blood Institute of the US National Institutes of Health (R01HS025164 and R01HL144644).",

year = "2021",

month = jun,

doi = "10.1038/s41591-021-01368-9",

language = "English (US)",

volume = "27",

pages = "940--943",

journal = "Nature Medicine",

issn = "1078-8956",

publisher = "Nature Publishing Group",

number = "6",

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TY - JOUR

T1 - Direct-to-consumer personal genomic tests need better regulation

AU - Moneer, Osman

AU - Miller, Jennifer E.

AU - Shah, Nilay D.

AU - Ross, Joseph S.

N1 - Funding Information: J.E.M. and J.S.R. receive research support through Yale University from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International. N.D.S. has received research support through Mayo Clinic from the Food and Drug Administration to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative; the Agency for Healthcare Research and Quality (R01HS025164, R01HS025402, R03HS025517 and K12HS026379); the National Heart, Lung and Blood Institute of the US National Institutes of Health (R56HL130496, R01HL131535 and R01HL151662); the National Science Foundation; and the Patient Centered Outcomes Research Institute to develop a Clinical Data Research Network (LHSNet). J.S.R. has received research support through Yale University from the Laura and John Arnold Foundation for the Collaboration for Research Integrity and Transparency at Yale; and receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale–Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); from the Agency for Healthcare Research and Quality (R01HS022882), and from the National Heart, Lung and Blood Institute of the US National Institutes of Health (R01HS025164 and R01HL144644).

PY - 2021/6

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U2 - 10.1038/s41591-021-01368-9

DO - 10.1038/s41591-021-01368-9

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SN - 1078-8956

VL - 27

SP - 940

EP - 943

JO - Nature Medicine

JF - Nature Medicine

IS - 6

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Direct-to-consumer personal genomic tests need better regulation

ASJC Scopus subject areas

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