Workshop on diagnostics: Can we drive use by making value visible?

Dear All (and with thanks to Robert Skov for co-authoring this newsletter AND with a wonkish alert for this is a complicated topic for which a compelling narrative is only now starting to unfold … so, get your coffee and be ready to follow the links as you read on!),

While we often talk in this newsletter about the need for new antimicrobials, the parallel narrative of the need to have (and use) diagnostics is equally pressing as these are the tools that enable the antibiotic stewardship programs that guide and preserve the utility of antimicrobials, both old and new. As summarized in prior newsletters, the gaps are significant:

• 4 Oct 2025 newsletter (“WHO: Reviews of antibacterial therapeutics and diagnostics“) where we learned that diagnostic gaps are notable, especially in low-resource settings:
  • “Few point-of-care tools for primary and secondary care
  • “No multiplex platforms for level II labs to detect bloodstream infections directly from whole blood (Level I = Primary care setting; Level II = District setting; Level III = Regional; Level IV = National)
  • “Access to biomarker tests to distinguish bacterial from viral infections remains limited”
• 1 April 2025 newsletter (“WHO pipeline reviews: Antifungal agents and fungal diagnostics“) where we learned that:
  • “Culture and histopathology are valid methods but slow and with limited sensitivity.
  • “The big gap is in non-culture-based methods where current tools are both relatively complex and reliable for only a few pathogens (Aspergillus, Candida, Cryptococcus, and some of the dimorphic fungi).
  • “With only a limited number of tests with the simplicity of a lateral flow immunoassay, WHO notes that the requirement with most tests for ‘well-equipped laboratories with well-trained laboratory staff, making access unevenly distributed, particularly in LMICs.’”

But underpinning these issues is the fact that utilization of diagnostics is suboptimal even in High-Income Countries (HICs) because diagnostics face economic issues that are in some ways more challenging than those of antibacterial/antifungal agents. Whereas we’ve made very good progress with understanding the economics needed to create and maintain the #FireExtinguishersOfMedicine (“Pull, please! Pull really hard!”), our efforts to solve the corresponding problem of the #SmokeDetectorsOfMedicine have struggled.

What, precisely, is the difference? Why, for example, were the collaborative DRIVE-AB and UK AMR Review  projects able to punch through the noise whereas as the equally collaborative VALUE-DX struggled?

Most fundamentally, it would seem that diagnostics struggle because they are viewed as a non-essential cost (as well as a source of delay). If you have an infection, you are readily convinced that you the need the drug but it’s very easy to do without the diagnostic if money is tight and/or you believe the drug in front of you is the best/only choice you have. After all, if the test is just going to tell you to do what you already planned to do, what’s the point of the test?

But this overlooks the point that diagnostics are the key to preserving antibiotic utility through antibiotic stewardship. Stated a bit differently, there are visible, immediate values of a diagnostic (choose the right therapy) and an invisible set of secondary values of a diagnostic (lower rates of resistance that will be important in the future). Interestingly, this begins to sound a lot like the fire extinguisher values of antibiotics, no?

So, and finally coming to the point of this newsletter, a new effort is underway to find a path for articulating the value of diagnostic tests as well as the need to deploy them. Specifically, a meeting was organized by multiple stakeholders (Africa CDC, AMR Action Fund, Aurobac Tx, bioMérieux, ESCMID) from 29 Sep to 1 Oct 2025 at Les Pensiéres Centre for Global Health in Annecy France. The meeting sought to find ways to articulate the challenges that limit diagnostic valuation and then create a plan that would lead to better diagnostic utilization.

The workshop brought together 45 stakeholders, from close to 40 organization and 18 countries. The workshop report has now been released and is available here. We got a small preview of it some its content during the session on diagnostics at GAMRIC 2025 (see video link below our signatures). The workshop concluded that we need parallel paths to address undervaluation and underutilization: 

1. Undervaluation
   • We need to create a shared, evidence‑based definition of the clinical, economic, and societal benefits of diagnostics
   • A good initial example a possible framework would be STRIDES, the extension of the STEDI value framework (for therapeutics) to diagnostics (see below for more on STRIDES).
   • We would need to pilot this framework to validate real‑world impact across patient outcomes, AMR mitigation, and long‑term health system savings.
2. Underutilization
   • Using arguments grounded in both the near- and long-term value of adequate use of diagnostics, we need to integrate rapid and high‑value diagnostic tests into routine clinical and veterinary pathways
   • This would require behavioral change at the provider level, updates to national guidelines, updates to financial support paradigms.
   • The need for changes in financial support paradigms will require shared metrics that show the alignment of the goals of payers, HTA bodies, providers, and patients.

Whew! It’s just the first step, but it is a very important first step in that this has the feel of the way that we finally learned in the 20-teens to articulate the value of antibiotics! 

• The key for antibiotics was finding a way to talk convincingly about their value-in-existence (or, value in the future when a resistant pathogen appears).
  • For more on the value frameworks now being used for antibiotics, see the 11 April 2022 newsletter entitled “UK Pull (‘Netflix-like’) pilot: STEDI-based QALY value of new antibiotics implies societal value > 10m GBP/year!”
• Finding the right words and perspectives to do this for diagnostics will be challenging and it’s great that such a diverse array of stakeholders have come together around this problem.
  • Importantly, follow-up meetings are planned to (i) consider the key value elements needed to assess diagnostic value and (2) ways to overcome the behavioral impediments.
  • For more on STRIDES as a possible value framework, see the 18 June 2025 newsletter entitled “Extending STEDI to diagnostics: STRIDES”, the paper by Fong, Bray, Hampson, and Steuten entitled “Taking STRIDES: The Value of Diagnostics Against AMR”, and the video below our signatures.

Well done by the meeting organizers … and we look forward to cheering you on!

All best wishes, John & Robert

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Robert Leo Skov, MD | ESCMID President | Epidemiology and Infectious Disease Preparedness, Serum Statens Intitut | robert.skov@escmid.org | All opinions are my own.