ProteinLogic develops a Rule-Out Test for Active TB

CAMBRIDGE, UK (2017-08-30) – ProteinLogic, a biomarker discovery company, funded by a grant by the European Union Horizon 2020 SME programme to develop a rapid point-of-care test for the diagnosis of Active Tuberculosis (TB), has achieved a significant milestone.

In 2015, 10.4 million people fell ill with TB and 1.8 million died from the disease. Over 95% of TB deaths occur in low and middle-income countries. Whilst 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 World Health Organisation 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 ProteinLogic TB test comprises a unique panel of biomarker proteins tested on over 1600 clinical samples from S.Africa, Uganda, Vietnam, Peru and London. In a recent study analysing 500+ high quality clinical samples, ProteinLogic scientists have 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.

Dr Alexander Betz, Chief Scientific Officer of ProteinLogic, commented “ProteinLogic has taken great care to use state of the art statistics and validation methodology and analysed the largest sample set to date exceeding anything published in the literature. In this latest study using over 500 well characterised prospective TB samples, we obtained results that meet and in fact exceed the target product profile for a rule out test set by the WHO. Whilst we need to do further validation studies to independently verify this, we are cautiously optimistic.”

ProteinLogic’s Chairman Mahesh Shah said: “We are excited by the results. This would not have been possible without the help and support of the European Commission in funding this exciting project. We would also like to thank FIND (Foundation for Innovate Diagnostics) who provided clinical samples and invaluable support. This is a significant step forward in the global fight to eradicate TB.”

The estimated market size for a Rule-Out Test for Active TB is estimated to be 80million tests per annum. Whilst India, China, South Africa and Indonesia represent almost 50% of the global market, there is also a sizeable market in Europe, US and Latin America with a market potential of over 5million tests per annum. The market potential varies according to the penetration of the test into decentralized settings and the patient populations or types of TB it detects. The ProteinLogic Test has also got the potential of being useful for the more difficult cases of extra-pulmonary TB and also Childhood TB.

Further information:

Mahesh Shah, ProteinLogic Ltd,


ProteinLogic is a biomarker discovery and exploitation company developing a novel diagnostic platform and diagnostic products that address key unmet medical needs in infection and inflammatory diseases. The Company has developed a proprietary biomarker technology (ImmiPrint®) with potential to diagnose and predict early onset of diseases, and to provide information as to how a disease is likely to develop and respond to particular drug treatments. The technology is based upon the profiling of a discrete subset of immune system proteins found in the blood and other body fluids.

In addition to the TB diagnostic test there are a number of potential follow-on products in the Company’s pipeline.

Horizon 2020

Horizon 2020 is the financial instrument of the European Union, implementing the Innovation Union, a Europe 2020 flagship initiative aimed at securing Europe’s global competitiveness. Horizon 2020 is the biggest ever EU research and innovation program. Through the SME Instrument, the European Union wants to finance the most innovative small companies with a high growth potential. The program promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market.

By coupling research and innovation, Horizon 2020 is helping to drive economic growth with its emphasis on excellent science, industrial leadership and tackling societal challenges. The goal is to ensure Europe produces world-class science, removes barriers to innovation and makes it easier for the public and private sectors to work together in delivering innovation.

Selected SMEs, showing a strong ambition to develop, grow and internationalise, shall be supported across Horizon 2020 with a dedicated instrument to provide staged and seamless support covering the whole innovation cycle.

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