Genome-Based Diagnostics Clarifying Pathways to Clinical Use: Workshop Summary (2012) / Chapter Skim
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7 Discussion of Major Proposals
7 Discussion of Major Proposals
Pages 49-60
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From page 49... ...
For example, Conti observed that in some areas of medicine, especially where good publications are available, it may cost far less to develop an LDT than the numbers Siegel cited in her presentation. CLIA provides much value to areas of medical practice, such as infectious diseases, endocrinology, or neurology, that are willing to accept published research as good evidence of treatment improvement.
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From page 50... ...
"Maybe we need to start talking about different LDT pathways and think about the benefits of each." van ‘t Veer agreed and also observed that the complexity of tests varies greatly. Some require many levels of analysis, data integration, and bioinformatics, while others are relatively simple molecular tests.
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From page 51... ...
An intermediate position proposed by Leonard is that FDA would formally decide what can go through an LDT pathway without FDA review based on risk-based stratification. This would be "a better strategy than eliminating the LDT pathway altogether," said Leonard, since there would be a negative impact on medical care if the LDT pathway did not exist.
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From page 52... ...
Furthermore, tests have to have positive margins, not just value, to be commercially appealing. CONSOLIDATING OFFICES WITHIN FDA Workshop participants also discussed Hayes' idea of combining FDA offices into a single oncologic office that looks at both diagnostics and therapeutics.
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From page 53... ...
Leonard suggested that NIH may increasingly be willing to consider funding for test validation research and that public-private partnerships also could consider funding evidence development for genomic tests to fill this gap. Jacques said that once ongoing pilot studies are completed, parallel review will be more formalized and that only a few years should be needed to generate enough experience to develop a framework or guideline for collaboration.
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From page 54... ...
"It may take forever to accrue that study. If Medicare from day one is essentially saying we're going to go ahead and pay for the item or service in this particular context, it seems that you would be able to more efficiently address FDA's issues as well as our issues." PROGRESSIVE APPROVAL AND REIMBURSEMENT PROCESSES Collaboration among FDA, CMS, and private payers could facilitate coverage with evidence development or other progressive approval processes for regulation and reimbursement, Leonard said.
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From page 55... ...
NIH could make it a requirement that samples be archived and available when it funds a clinical trial, as is being done at the National Institute of Diabetes and Digestive and Kidney Diseases. On the same topic, a participant said that one way to break the vicious cycle of undervalued genomic diagnostic tests is through coverage for field evaluation.
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From page 56... ...
Tunis observed that the sophisticated analysis of routinely collected data generated in the course of care could be informative about clinical utility, but the question needs to be asked whether such information will have sufficient reliability to inform decisions. "It goes back to my point .
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From page 57... ...
Tunis observed that the process by which FDA derives regulatory guidance is one example of how to arrive at a collective social judgment, since it is an iterative public process in which there is a push and pull among stakeholders that occurs through a transparent process. Khoury also pointed to the experience with EGAPP, which was based on the model used by USPSTF for clinical preventive services.
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From page 58... ...
Then we need that space by which validated technology moves into practice in a way that makes sense." Billions of dollars are now being spent to make new discoveries. The additional expense of doing knowledge synthesis would not be that great, and without such a mechanism, the money spent on basic science discovery will not result in better health outcomes.
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From page 59... ...
59 DISCUSSION OF MAJOR PROPOSALS of information, some of which has never been uncovered before. In particular, he called attention to the importance of clarity.
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