How current assay approval policies are leading to unintended imprecision medicine

Affiliations

¹ Division of Research, Peter MacCallum Cancer Centre, Melbourne, VIC 3000, Australia; Department of Pathology, GZA-ZNA Hospitals, Wilrijk, Antwerp, Belgium. Electronic address: roberto@salgado.be.
² Department of Pathology, University of Iowa Carver College of Medicine, Iowa City, IA, USA.
³ Department of Pathology, Yale School of Medicine, New Haven, CT, USA.
⁴ Diagnostic Development, Ontario Institute for Cancer Research, Toronto, ON, Canada.
⁵ Department of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC, Canada.
⁶ Department of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
⁷ Department of Surgical Pathology, Zealand University Hospital, Roskilde, Denmark.
⁸ Department of Pathology, St Vincent's University Hospital, Dublin, Ireland.
⁹ Department of Pathology, Bács-Kiskun County Teaching Hospital, Kecskemét, Hungary; Department of Pathology, University of Szeged, Szeged, Hungary.
¹⁰ Institute of Anatomical Pathology, Rede D'Or São Luiz Hospitals Network, São Paulo, Brazil; D'Or Institute for Research and Education, Rio de Janeiro and São Paulo, Brazil.
¹¹ Department of Pathology, Hospital de Oncología, CMN, SXXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico.
¹² International Agency for Research on Cancer, World Health Organization, Lyon, France.

Roberto Salgado et al. Lancet Oncol. 2020 Nov.

. 2020 Nov;21(11):1399-1401.

doi: 10.1016/S1470-2045(20)30592-1. Epub 2020 Oct 21.

¹ Division of Research, Peter MacCallum Cancer Centre, Melbourne, VIC 3000, Australia; Department of Pathology, GZA-ZNA Hospitals, Wilrijk, Antwerp, Belgium. Electronic address: roberto@salgado.be.
² Department of Pathology, University of Iowa Carver College of Medicine, Iowa City, IA, USA.
³ Department of Pathology, Yale School of Medicine, New Haven, CT, USA.
⁴ Diagnostic Development, Ontario Institute for Cancer Research, Toronto, ON, Canada.
⁵ Department of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC, Canada.
⁶ Department of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
⁷ Department of Surgical Pathology, Zealand University Hospital, Roskilde, Denmark.
⁸ Department of Pathology, St Vincent's University Hospital, Dublin, Ireland.
⁹ Department of Pathology, Bács-Kiskun County Teaching Hospital, Kecskemét, Hungary; Department of Pathology, University of Szeged, Szeged, Hungary.
¹⁰ Institute of Anatomical Pathology, Rede D'Or São Luiz Hospitals Network, São Paulo, Brazil; D'Or Institute for Research and Education, Rio de Janeiro and São Paulo, Brazil.
¹¹ Department of Pathology, Hospital de Oncología, CMN, SXXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico.
¹² International Agency for Research on Cancer, World Health Organization, Lyon, France.

No abstract available

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