Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests Workshop Summary (2014) / Chapter Skim
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4 Perspectives of Diagnostic Test and Pharmaceutical Developers
4 Perspectives of Diagnostic Test and Pharmaceutical Developers
Pages 29-40
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From page 29... ...
• Development of test registries to compare test results across multiple laboratory settings could establish stronger links between test performance and clinical outcomes. • Several pharmaceutical companies have established internal diag nostic groups for co-development, but the companies have not overlooked the value of collaborating externally with experts.
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From page 30... ...
. While Koch noted that FDA recognizes Sanger sequencing as the "gold standard" for variant detection in the absence of an FDA-approved test, he pointed out that it may be poorly suited for cancer tissue mutation analysis because of known poor sensitivity for samples containing less than 25 percent mutant alleles, which is frequently the case in cancer (Anderson et al., 2012; Halait et al., 2012)
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From page 31... ...
"They are not limited simply by that companion diagnostic." Koch said that payment reform is needed "to recognize the value of advanced medical diagnostic tests, their impact on health care, and the resources needed to develop and clinically validate them." Inadequate pay
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From page 32... ...
She agreed with ASCO's point about the challenge of regulatory uncertainty regarding FDA oversight of companion diagnostic LDTs. Having a better understanding of the enforcement discretion of LDTs would be useful for providing evidence for clinical utility and not just analytical performance.
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From page 33... ...
For instance, though the CAP proposal emphasizes the analyte be used for drug efficacy, defining an analyte this way does not address the test technology and assay variability among different methodologies. An important point to make, she said, is that an IVD is a system that extends from sample preparation through test generation and bioinformatics to the "algorithms that determine whether a patient is positive or negative, and the cutoff that's used is really the heart of the IVD device." AREAS FOR CONSIDERATION Additional considerations, including financial reimbursement and coding requirements, may need to be addressed in order to improve the current system of IVD use.
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From page 34... ...
For example, extensive information technology and data storage capabilities to fully analyze complex datasets will be needed, Swatkowski said. Because there are a variety of platforms and sequencing technologies, "any regulatory requirement should have the flexibility to adapt to rapidly changing technology." considerations for ivds and ldts The single aim of Amgen's companion diagnostics effort is to "accurately identify those patients who can benefit most from therapy," said Scott Patterson, executive director of medical sciences for Amgen.
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From page 35... ...
At the same time, more robust EQA programs are needed in order to produce consistent patient selection along with transparency of results from EQA laboratories (van Krieken et al., 2013)
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From page 36... ...
If the goal of the combined cost model (see Box 1-2, individual participant submission) for the drug and test is to enforce the use of IVDs, a laboratory is unlikely to use an LDT because it would be paid only a service fee, said Bruce Quinn, senior health policy specialist with Foley Hoag LLP (see Figure 4-1)
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From page 37... ...
$400 Kit IVD $ CASH MFGR R&D Regulatory PHARMA $ Drug Combination Approval and Drug Labeling Diagnostic Kit and # Kits $600 Service Platform $ CASH "Free" LAB PAYER # Kits Test Result $ Drug DOCTOR FIGURE 4-1 Proposed payment model for connecting the costs of co-developed companion diagnostics to those of the related drug. NOTE: IVD, in vitro diagnostic; MFGR, manufacturer; PHARMA, pharmaceutical company; R&D, research and development.
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From page 38... ...
The performance of tests can vary greatly, even after approval. Buller exhibited the positive rate of the Abbott Vysis LSI Break Apart FISH Probe Kit which was used to test for ALK in four different central laboratories following FDA approval of the test and drug.
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From page 39... ...
TEST REGISTRIES The use of registries as a test bed for comparative effectiveness research across the spectrum of different diagnostic testing platforms was debated during the ensuing panel discussion. The moderator of the session, Geoffrey Ginsburg, director of the Center for Genomic Medicine at Duke University, specifically queried the four speakers about the potential value of test registries for comparing the efficiency of multiple LDTs.
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From page 40... ...
While its pharmaceutical partners, such as Genentech, do have integrated diagnostics groups, they primarily focus on understanding disease biology both in preclinical and early clinical trials. Buller and Koch both noted that by not having internal diagnostic units, the enterprise has more flexibility to collaborate with the best external groups.
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