Global Health Labs

Designing a sensitive tuberculosis test for low-resource settings

The challenge

Tuberculosis (TB) remains one of the world’s deadliest infectious diseases, with around a quarter of the world’s population infected with Mycobacterium tuberculosis. Most people never develop symptoms, but those with weakened immune systems or other risk factors face a much higher chance of developing active TB. Early signs – such as coughing, fever, and weight loss – can be vague, making timely diagnosis difficult. 

The World Health Organization’s End TB Strategy highlights the need to identify infected people who are more likely to develop active TB, and to diagnose active and drug-resistant cases as early as possible. Yet in many low-resource settings, testing still depends on centralised labs or distant clinics, requiring long travel times or complex sample transport – hindering rapid care. 

US company Global Health Labs (GHL) – backed by Gates Ventures – set out to overcome these barriers by developing a self-contained, tongue swab-based molecular test with the ease-of-use of a lateral flow device. Their goal was a cartridge-style diagnostic tool that delivers reliable results at the point of care with minimal resources. To solve the associated design and manufacturing challenges, their UK partner Global Access Diagnostics (GADx) introduced them to CPI

GHL and GADx developed a concept for an instrument-free molecular diagnostic platform with a user experience akin to the rapid diagnostic tests used during the COVID-19 pandemic. However, we needed help figure out how to scale up and CPI helped us with their team of engineers and material scientists to do just that. The work they did on identifying new, more consistent materials and creating bespoke tools enabled us to create functional prototypes for advanced testing, proving the capabilities of the platform.” 
John Connelly
John Connelly, Director, Diagnostics – Global Health Labs 

How CPI helped

  • Manufactured flexible printed heaters to enable sample incubation and flow control in the cassette. 
  • Selected and evaluated new wax materials to control fluid flow during the test cycle. 
  • Supported material selection, layer design, and fluid routing for device functionality. 
  • Assembled 8‑layer prototype cassettes using bespoke tooling and supplied functional demonstrators. 

Achievements

  • Created a layered, stackable demonstrator device ready for pilot production. 
  • Enabled detailed lab testing to take place, bringing the product closer to market. 
  • Supported Global Health Labs to improve the design of the device, taking it from concept to prototype stage. 

Impact

This project is redefining what’s possible for point-of-care diagnostics in underserved communities. By delivering molecular-level accuracy in a compact, low-cost format, the test has the potential to dramatically improve TB detection – enabling earlier treatment, better patient outcomes, and reduced risk of transmission in settings where traditional diagnostics can’t reach. 

CPI’s contribution helped Global Health Labs progress from concept to a validated prototype, solving complex engineering challenges such as thermal control and fluid management. Our work accelerated the product towards field trials and commercial handover, with the project now being advanced with further support from the Gates Foundation. 

By overcoming the barriers to scalable, decentralised diagnostics, this partnership is helping build a future where high-quality TB testing is accessible, affordable, and capable of improving health outcomes for communities most affected by the disease. 

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