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: [email protected].
• 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.