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From Innovation to Access: Bridging the Last-Mile Gap in TB Diagnostics

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We are not short of TB diagnostics. We are short of access.

Each year, an estimated 3–4 million people with TB are either undiagnosed or unreported, according to the WHO Global TB Report. This is not a failure of science.

Over the past decade, WHO-endorsed rapid molecular diagnostics have transformed our ability to detect TB and drug resistance early, with high accuracy. The policy is equally clear — the World Health Organization recommends molecular testing as the initial diagnostic for TB.

Yet implementation remains uneven.

In many high-burden settings

  • Molecular platforms are still concentrated at centralized laboratories
  • Primary care settings continue to rely on smear microscopy
  • Patients experience diagnostic delays, often continuing transmission before detection

Reports from global TB partners consistently highlight that diagnostic networks are not yet optimized for last-mile access, particularly in rural, peri-urban, and conflict-affected settings.

Where Strategic Shifts Are Needed

Decentralisation of molecular diagnostics
Scaling access beyond district-level facilities to true point-of-care settings is critical to reduce diagnostic delay and loss to follow-up.

Faster, harmonised regulatory pathways
Validated, field-suitable IVDs require accelerated adoption mechanisms in high-burden countries to reduce time-to-impact.

Rebalancing TB financing toward diagnostics
Current funding patterns remain disproportionately weighted toward treatment. Yet without early detection, case-finding targets and transmission reduction goals will not be met.

Incentivising last-mile delivery models
Procurement and partnership frameworks must evolve to reward reach, equity, and accessibility — not just testing volumes.

A Critical Window for Impact
The WHO End TB Strategy sets 2030 as the target horizon. With less than five years remaining, incremental improvements will not be sufficient.
Closing the diagnostic gap will require:

  • Alignment between policy, funding, and implementation
  • Stronger public–private collaboration
  • Continued leadership from global partners

At EMPE Diagnostics, we are contributing through the development and multi-country validation of molecular TB platforms designed for real-world, high-burden settings. But innovation alone will not close the gap.

The next phase of TB control will be defined not by new tools — but by how effectively existing tools reach the people who need them most.

The evidence is clear. The tools are available. The priority now is equitable implementation — at scale, and with urgency.