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Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests Workshop Summary (2014) / Chapter Skim
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6 Concluding Observations
Pages 49-54

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From page 49...
... It just doesn't make sense." Thompson agreed that this is an area for concern because in a system for generic diagnostics, FDA initially approves the companion diagnostic, and then a lab could decide to make a very similar test, validate it, and then sell it as a companion diagnostic for an associated drug. The pioneer of the test achieves FDA approval, but others can produce the same generic test that is subject to CLIA instead.
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From page 50...
... This could be accomplished R through a more robust CLIA accreditation process, a risk-based approach to regulation by FDA, or by choosing one path to assure the safety and effectiveness of all companion diagnostics, regardless of their source. •  roviding a mechanism to regulate follow-on tests may help provide more P comparable economic incentives for IVD and LDT developers to produce diagnostics.
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From page 51...
... •  learning health care system, that, with research and payer support, uses A clinical data to improve patient care moving forward. •  he establishment of a national testing and outcomes database to generate T evidence for improving clinical care.
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From page 52...
... generating evidence for test value Leonard and Burke agreed that generating good evidence about how to get the right drug to the right patients at the right time remains a major issue and that randomized controlled trials will not be possible in all circumstances, which will require new study designs. Neither CLIA nor FDA formally assesses clinical utility, although payers are very interested in this issue, Leonard said.
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From page 53...
... It could bring more rationality into the system if the recipients of health care have a louder voice in deciding what they are willing to cover out of their own pockets. The development of national guidelines for clinical utility would be beneficial for the health care provider community in a value-based payment model, the workshop participant said.
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From page 54...
... "Health plans are not the solution to fill all these evidence gaps that exist," she said. Finally, Swatkowski offered the perspective that companion diagnostics may be an interim step to understanding disease and mutations that are unique to particular patients.
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Key Terms

  • clinical utility
  • patient care
  • companion diagnostic
  • improve patient
  • national testing

  • diagnostic tests
  • fda approval
  • clinical data
  • robust clia
  • clinical trial

  • speakers identified
  • ldt developers
  • workshop participant
  • accreditation process
  • regulatory oversight

  • genetic alliance
  • evidence suggesting
  • test value
  • laboratory accreditation
  • establishing laboratories

  • develop companion
  • victoria pratt
  • moving forward
  • clinical trials
  • generate variable

  • nomic incentive
  • studying negative
  • test accuracy
  • established tests
  • controlled trials


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