HHS Request for Information (RFI) Diagnostic Testing for Lyme

As part of the LymeX public-private partnership between Health & Human Services (HHS) and the Cohen Foundation, HHS has published an RFI in the Federal Register, 2.11.21 that seeks information on the current state of the science and technology to accelerate “innovative solutions” for Lyme disease diagnosis.

The RFI contains a series of questions it encourages responders to answer including the types of technologies being developed, any emerging technologies that could be used to characterized stages of Lyme, what sample type optimum for a detection test, and challenges in clinical practice.

Responses need to be submitted no later than 5:00 PM ET, March 15, 2021.

See the Federal Register for all details:
Request for Information (RFI): Accelerating Innovation in Diagnostic Testing for Lyme Disease

See LDA website: HHS, Steven & Alexandra Cohen Foundation Announce “LymeX” Partnership


From the HHS website (please go to link for more info):

We encourage responders to answer the following questions:

  • What challenges/barriers exist for the development and validation of innovative diagnostic tests for Lyme disease?
  • What types of diagnostic technologies are being developed (or could be developed or adapted) to detect Lyme disease, including technologies and breakthroughs adapted from COVID-19 diagnostics with potential applications for Lyme disease (e.g., highly sensitive nucleic acid amplification testing [NAAT])?
  • What emerging technologies (e.g., epigenetic mapping, inflammatory markers, gene arrays, NAAT, or others) might be developed or adapted to characterize different stages of Lyme disease, including Post-Treatment Lyme Disease Syndrome (PTLDS), etc.?
  • What analyte (e.g., DNA, RNA, protein, metabolite) does existing or developing Lyme disease diagnostic tests detect?
  • What is the optimal sample type (e.g., whole blood, plasma) for the detection of a test analyte in patients with Lyme disease? The optimal sample type can be generally defined as the one where the analyte can be best detected.
  • What challenges exist in the implementation and use of Lyme disease diagnostic testing in clinical practice?
  • What role can or should public-private partnerships play in accelerating Start Printed Page 9077development, validation, or appropriate use of innovative Lyme disease diagnostic tests, and what factors are most critical to ensure their success?

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