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ADVANCE Discourse: Lab

AMP Members Respond to GTR

Published November 19, 2010 8:16 PM by Kelly Graham

What an interesting workshop this afternoon at the AMP Annual Meeting discussing the National Institutes of Health Genetic Test Registry (GTR)! A recent survey of AMP members gathered opinions on the use, benefits and concerns of the GTR, which is still in developmental stages. Check out some of the AMP member responses below, presented by Vicky Pratt, PhD, FACMG, on the AMP Professional Relations Committee.  

What kind of tests should be included in a GTR?

  • Inherited disorders: 88%
  • Somatic disorders: 75%
  • Pharmacoghenetics: 75%
  • Biochemical genetics: 71%
  • Infectious disease genetics: 58%
  • Recreational genetics: 32%

Which groups would be a relevant audience for a GTR?

  • Healthcare providers: 88%
  • Other labs: 66%
  • Researchers: 50%
  • Public/patients: 45%
  • Regulatory agencies: 42%
  • Payers: 42%

What information would you be willing to provide to a GTR (incomplete list)?

  • Test name: 87%
  • Mutation/analytes tested: 79%
  • Lab's contact info: 77%
  • Sensitivity/specificity: 55%
  • Clinical use category: 53%
  • CPT code: 52%
  • Regulatory status of assay/reagent: 50%
  • Lab personnel certification: 39%
  • Quality measures: 37%
  • Positive/negative predictive value: 30%
  • Lab report: 31%
  • Cost: 23%

The next steps to getting a functional Genetic Test Registry up and running? Continue to analyze the responses received; continue engagement with FDA, CDC, CMS, ARHQ; maintain contact with all stakeholders; convene focus groups; develop registry and beta test; launch in the coming spring (hopefully); and continue analyzing usage after launch.

 What are your thoughts on the GTR? Is it necessary? Useful? What kind of information do you think should be included? What concerns do you have? Comment below! 

posted by Kelly Graham


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