Abstract
The development of advanced genetic sequencing technologies and genomic testing services challenges the existing regulatory framework for clinical laboratory testing. These challenges will demand a refinement and adaptation on the part of laboratories, professional and accrediting organizations, vendors and manufacturers, and regulatory agencies of existing standards and practices to accommodate novel genomic technologies and clinical applications. The value of existing concepts of laboratory developed tests and companion diagnostics will need revision in order to accommodate genomic sequencing assays. This chapter addresses these issues and the notion that, to some extent, these novel technologies will challenge established definitions of disease, and the foundations of medical practice.
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References
42 CFR 493.1253: Standard—establishment and verification of performance specifications, and 42 CFR 493.1254—standard—maintenance and function checks.
Proposal to address CPT coding for genomic sequencing procedures, Association for Molecular Pathology Economic Affairs Committee, Mar 2013.
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Nowak, J.A. (2015). Regulatory and Reimbursement Issues in Genomic Testing. In: Netto, G., Schrijver, I. (eds) Genomic Applications in Pathology. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-0727-4_9
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DOI: https://doi.org/10.1007/978-1-4939-0727-4_9
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