The Need for New Diagnostics

Tuberculosis (TB) is the leading infectious disease cause of death globally. According to the World Health Organisation (WHO), in 2015, 10.4 million people fell ill with TB and 1.7 million died from the disease. Over 95% of TB deaths occur in low and middle-income countries.

While TB incidence has fallen by an average of 1.5% per year since 2000, there is an urgent need to accelerate this to a 4–5% annual decline. The WHO has set a 2035 target of 95% reduction in deaths and a 90% decline in TB incidence – similar to current levels in low TB incidence countries today. To achieve this the WHO has called for the accelerated development of new tools for the diagnosis of TB. A panel of international experts on TB agreed that highest on their list of priorities was the development of a rule-out test that can be used by first-contact health-care providers to identify those who need further testing (the triage test). Such a rule-out test can also be used as a systematic screening test for active case-finding.

A rule-out test for active TB has significant potential impact on TB transmission. By enabling the early identification of those symptomatic patients who do not have TB, healthcare professionals can focus on the smaller numbers who test positive to investigate further to diagnose and treat those with Active TB. Each person with Active TB can potentially spread the disease to many others thus feeding the cycle of transmission of the disease.

The estimated market size for a Rule-Out Test for Active TB is to be 80 million tests per annum. India, China, South Africa and Indonesia represent almost 50% of the global market. However, there is also a sizeable market in Europe, US and Latin America with a potential of over 5 million tests per annum.

ImmiPrint For TB

The ImmiPrint® TB test comprises a unique signature of biomarker proteins, alongside diagnostic models developed through Machine Learning. The signature was first established on over 1000 clinical samples from S. Africa, Uganda, Vietnam and Peru.

The ImmiPrint® TB signature has now been fully validated against 800 high quality, prospectively collected, ethnically diverse clinical samples sourced from hospitals in London, UK. This latest study is one of the largest found in the literature to date. ProteinLogic used state-of-the-art Machine Learning to enhance its diagnostic models.

ProteinLogic has now achieved a level of accuracy (measured by sensitivity, specificity, negative predictive value and positive predictive value) comfortably exceeding the WHO criteria for a rule-out test. Importantly, ProteinLogic’s TB test has been proven to be equally sensitive in the more difficult-to-diagnose cases of extra-pulmonary TB.

ProteinLogic tests are primarily quantitative in nature. Early evidence supports that ProteinLogic’s approach can potentially be used for the monitoring of TB progression from Latent to Active, and the testing of the effectiveness and completion of treatment for Active TB. ProteinLogic is actively exploring these potential applications.

Addressing the Need

ProteinLogic is actively further validating the Active TB rule-out test in clinical practice, in collaboration with leading Tuberculosis Key Opinion Leaders globally, working to bring a new diagnostic to market to make a difference in the fight to eradicate TB.

Funding and Support

The work for the development of a new Active TB rule-out test has been funded by a European Commission Horizon 2020 grant.

The work has also been supported by the Foundation for Innovative Diagnostics (FIND), providing the clinical samples that were used early in the development of the test.