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Develop Programs To Speed Diagnosis

Developing Reduced Cost Programs

Depending on how your disease is diagnosed, you may be able to work to offer free or reduced diagnostic testing either through your clinical network if one is established or with the help of a larger umbrella group that includes your disease. 

  • Work with your Scientific/Medical Advisory Board and clinical network to brainstorm possible ways to speed diagnosis.
  • Collaborate with the Sponsor and/or manufacturer of the newly approved therapy to develop diagnostic programs.
  • Consider factors that may affect your ability to develop a program. For example:
    • It may be easiest to develop a program for diseases diagnosed or confirmed by specific tests, such as:
      • Genetic testing
      • Bloodwork
      • Biopsies
    • It may be more difficult for diseases that are still diagnosed clinically, through exclusion of other possible causes, or require multiple tests.

Resources

Newborn Screening
Advisory Committee on Heritable Disorders in Newborn and Children U.S. Health Resources & Services Administration (HRSA) (link)
Recommended Uniform Screening Panel (RUSP) U.S. Health Resources & Services Administration (HRSA) (link)
Parental Permission for Pilot Newborn Screening Research: Guidelines From the NBSTRN Newborn Screening Translational Research Network (NBSTRN) (link)
CDC Newborn Screening Portal Centers for Disease Control and Prevention (CDC) (link)
Baby's First Test Public Square Baby's First Test (link)
Tips for Success
National Coordinating Center for the Regional Genetics Networks About Us National Coordinating Center for the Regional Genetics Networks (link)
Genomics Revolution: Reliability and Access Global Genes (link)
PCORI Funding Informational Presentation Global Genes (link)
Patient-Centered Outcomes Research Institute (PCORI) About Us Patient-Centered Outcomes Research Institute (PCORI) (link)