GAO has released a massive 135-page report on the state of antibiotics development, resistance, and the health of antibiotics R&D in the United States and internationally.
See the GAO report here. See coverage at Endpoints here.
Much emphasis on the poor economics of antibiotics development, the growing need, and the lack of "postmarket" actions (in addition to depositing money in startups to help R&D.)
I noted there are nearly 20 pages devoted to diagnostics (pages 35-53.)
The high-level bullet point for diagnostics is:
- "Clarify roles and responsibilities to assess the clinical outcomes of diagnostic testing"
- Challenges in Addressing Diagnostic Test Gaps
According to federal documents and literature, challenges to diagnostic test development include:
• Lengthy and costly regulatory requirements, including additional regulatory hurdles in other countries
• Limitations in technical feasibility assessments due to intellectual property protection and conflict of interest requirements
• Differences in expertise between manufacturers and regulatory bodies
• Limited evidence on cost-effectiveness and clinical outcomes for using tests
• Limited resources in some settings to transport specimens, conduct, and maintain tests
Note that GAO had done an earlier report in 2017, "Challenges and Capabilities to Enable Rapid Diagnoses of Infectious Disease," (64pp) here.