Geneva – 26 September 2014. UNITAID releases today its 2014 Tuberculosis Diagnostics Technology and Market Landscape, detailing the promising pipeline of products and technologies to diagnose tuberculosis (TB). The report highlights current and emerging technologies from over 80 manufacturers and developers, including products which are smaller, simpler and easier to use in decentralized settings than the current tools used by the majority of high-burden TB countries.
According to the World Health Organization (WHO), one third of all TB cases were not diagnosed or reported to national TB programmes in 2012. For multidrug-resistant TB (MDR-TB), the situation is even more serious: WHO estimated that fewer than 1 in 4 cases was detected in 2012. Rapid, accurate diagnosis is critical for timely initiation of treatment and to halt the spread of this airborne disease. Childhood TB is also very difficult to diagnose, meaning the true case burden of paediatric TB is higher than estimated, and many children in need are not identified and therefore do not receive TB treatment.
Part of the reason for these “missed” cases is the lack of access to appropriate diagnostic tools. Most high-burden countries still rely on sputum smear microscopy, which cannot detect drug resistance. Tests to detect resistance are available only in regional or reference laboratories in most countries.
The biggest recent change in the TB diagnostics market has been the introduction of the GeneXpert® MTB/RIF automated molecular diagnostic machine, with over 3200 instruments and 7.5 million Xpert® MTB/RIF cartridges procured in the public sector in 108 countries, including by UNITAID. While Xpert offers rapid testing and can detect some, it remains expensive and not adapted for the most decentralized health-care settings. New products are still needed to address unmet needs in TB diagnosis.
According to the new report, the diagnostics technology landscape looks promising. The range of technologies that may replace smear microscopy continues to expand. In addition, in the next two to three years, new products on the market will compete with Xpert technology and address other diagnostic needs – provided that sufficient evidence is available to inform policy on new products’ use. Many of these products are designed to operate in the most decentralized environments by virtue of their smaller size, reduced complexity, increased robustness and use of battery power.
Among the technologies reviewed in the landscape:
- Chest X-rays and computer-aided diagnosis
- Microscopy and associated tools
- Culture-based tools for diagnosis and drug susceptibility testing
- Biomarkers to detect active or latent TB
- Serodiagnostic assays
- Volatile organic compounds
- Nucleic acid amplification technologies (NAATs) and sequencing methods
In addition, the Landscape details market developments and issues, including shortcomings that create obstacles to access. Potential market interventions are also explored.