Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests Workshop Summary (2014) / Chapter Skim
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3 Perspectives from Patients, Providers, and Laboratory Representatives
3 Perspectives from Patients, Providers, and Laboratory Representatives
Pages 19-28
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From page 19... ...
A variety of individuals use companion diagnostics and the results of these tests, including patients, health care providers, and clinical laboratory employees. Representatives of each of these three end-user groups described the value and problems with co-developed companion diagnostics along with the changes that can be expected as next-generation sequencing becomes a more prominent part of clinical practice.
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From the patient perspective, health care providers do not always have a clear sense of what is most useful to patients. Providers may overtreat, undertreat, inappropriately treat, or not treat at all, based on the available information.
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Health care is going to have to be like a civil rights issue, she said. People have a right to demand not just tests and treatments, but also solutions to the health problems they confront.
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Clinical laboratories have a different set of issues than health care providers, Pfeifer continued. First, the laboratories typically face limitations in
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From page 23... ...
, further constrain testing, Pfeifer said, because producing samples to do such assays reduces the amount of t issue available for other tests. Another challenge with tissue samples is that the type of sample and the preparation needed for a companion diagnostic test may not always align with the type of sample that is most non-invasive to obtain and that makes most sense from the patient care perspective.
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From page 24... ...
The American Clinical Laboratory Association proposal recognizes that LDTs are part of the genetic testing landscape and proposes a regulatory framework consistent with the precedent for other types of laboratory testing. A disadvantage to this proposal is that it would apply to the direct-toconsumer market, in which health care providers are not involved in the testing for inherited mutations, Pfeifer said.
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From page 25... ...
If that is not the case and each person is unique, then the rare disease model of regulation would apply. There is also a need for general methodology, or at least for an intellectual framework, to delineate what sequence alterations potentially predict response, and because directly evaluating every single sequence variant as small n of 1 clinical trials is not feasible, Robson said, "we need some creative thinking about designs." Evaluation of Genomic Applications in Practice and Prevention, along with other groups such as the Clinical Sequencing Exploratory Research consortium, Blue Cross and Blue Shield Association Technology Evaluation Center, and Kaiser Permanente, serve as reviewers of the evidence base.
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From page 26... ...
Nevertheless, Robson added that his institution is already using nextgeneration sequencing in cases where potential germline predispositions are difficult to define phenotypically. For instance, he said, "pediatric bone m arrow failure syndromes can be due to a number of different things that are hard to sort out phenotypically and are very expensive to test serially." As a result, Memorial Sloan Kettering uses next-generation sequencing panels to gather as much information as possible for conditioning regimens prior to transplantation.
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From page 27... ...
It's learning in the hope that we may improve outcomes in the future." Terry also pointed to the potential for genomics to generate disparities in health care because some patients may have better access to information or to providers and may know how to navigate the system to gain the information that they need. Pfeifer explained several other ways in which genomics can add costs.
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From page 28... ...
Old models to address these questions are not necessarily going to work, Terry said. Finally, Pfeifer agreed with Terry that everyone is a consumer of health care and they are involved in different areas along the spectrum of the health care system.
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