Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests Workshop Summary (2014) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-6
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Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. Somatic genome information can be used to guide therapy for cancer treatment and germline information can be used to assess risk of inherited diseases and to avoid adverse reactions to drugs.
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and reimbursement, the economic model, and clinical lab challenges. There is concern over the regulatory uncertainty that exists for companion diagnostic tests in particular over whether they should either be reviewed by FDA or through oversight by the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
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After FDA issued its draft guidance, many questions were raised by stake holders, specifically health care providers, clinical laboratories, test developers, pharmaceutical companies, and payers. Because drug development and test development have very different characteristics, questions were raised about timelines, required resources, market protection, intellectual property, market size, and potential profits.
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Furthermore, if an FDA approved test is modified and improved by a CLIA laboratory, it is considered an LDT.a CLIA sets standards for analytical validity and quality assurance for LDTs, but, according to Scott Patterson of Amgen, a major question for stakeholders is whether LDTs have the same assurance of performance characteristics as an IVD approved through the FDA co-development process. a linical Laboratory Improvement Amendments.
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• better understanding of tumor biology and drug–target interactions A involved in the use of a predictive biomarker is needed before a predictive biomarker is selected for development and validation. Regulatory certainty regarding FDA oversight of LDT companion diagnostics is needed, with coordination between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health.
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Chapter 5 focuses on the regulatory environment for the marketing of co-developed companion diagnostics, the regulatory scrutiny that should be given to IVDs and LDTs, demonstrating the safety and effectiveness of devices, and reimbursement decisions based on clinical utility. Finally, Chapter 6 outlines observations made by individual speakers and workshop participants about the possible solutions in Box 1-2 for addressing the current co-development landscape.
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