Genomic biomarkers for cancer assessment: implementation challenges for laboratory practice

Clinical Biochemistry
Kenneth P H Pritzker, Azar Azad

Abstract

Genomic biomarkers are an emerging class of laboratory tests, which present special implementation challenges for clinical laboratory services, compared to conventional laboratory tests. These challenges, which include analytical, bioinformatics, bioethical, interpretation and commercialization issues, represent real obstacles to widespread implementation of these tests. Technical challenges include the capacity to detect and identify many different kinds of markers for different diseases in a short time period, capacity to identify simultaneously gene rearrangements, amplification, inhibition, deletions and replications. Bioinformatics challenges include rapid analysis of genomic data, as well as the cross reference to other genomic data, and to other laboratory tests. Bioethical issues relate to consent to retain and use genetic data, which may be obtained inadvertently during analysis for genomic markers. Interpretation challenges include observations that the particular genomic markers may not be independent variables, as other undetected genomic alterations could invalidate or alter genomic marker interpretation. Further, as early experience with predictive genetic markers for cancer has shown, proprietary commercial inter...Continue Reading

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Citations

Aug 1, 2009·BMC Health Services Research·Fiona A MillerSuzanne Kamel-Reid
Jan 1, 2012·Expert Opinion on Medical Diagnostics·Kenneth Ph Pritzker, Laura B Pritzker
Aug 4, 2006·Molecular Diagnosis & Therapy·Sudhir Srivastava
Oct 18, 2020·Journal of Personalized Medicine·Kenneth P H Pritzker

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