GBD Receives Wellcome Trust Support for Development of New TB Diagnostic

A UK company has received a £2.6m($4.3m) Strategic Translation Award from the Wellcome Trust to progress its development of a new, rapid point-of-care test for the diagnosis of tuberculosis, one of the world’s biggest killers.

Global BioDiagnostics (GBD), based at Sci-Tech Daresbury, Cheshire, UK, and Texas, USA, has received the Wellcome Trust money after completing a proof of concept study of a new technique for the diagnosis of tuberculosis.

The test can detect the bacterium that causes TB in as little as 10 minutes. It is based on technology developed at Texas A&M and Stanford and recently described in Nature Chemistry.

The ultimate goal is to develop an accessible, affordable test that can be used at the point of care level in communities across the developing world.

A benchmark evaluation study undertaken in the US and Peru using fresh sputum from suspected TB patients has proven feasibility of the technique for the rapid diagnosis of TB.

Michael T. Norman, CEO of Global BioDiagnostics, said: “This new funding will support refinements of the assay technology and further product development work culminating in field trials of the diagnostic test and CE registration.

“We hope to develop a test that will enable accurate diagnosis at an earlier stage of infection, while requiring little by way of clinical or technical skill, in a matter of minutes and at a fraction of current costs.”

The new diagnostic test uses technology developed by Dr Jeffrey D Cirillo of Texas A&M Health Science Center College of Medicine, near Houston, and Dr Jianghong Rao of Stanford University, California.

The basic research has taken more than five years and has been funded through an on-going £3m-plus ($5m-plus) grant from the Bill and Melinda Gates Foundation to Texas A&M.

The technology utilizes novel chemical substrates that generate a fluorescent signal when they come into contact with an enzyme produced by the bacterium causing TB. This technology is called Reporter Enzyme Fluorescence, or REF.

The fluorescent signal is easily detected by simple, low cost, portable fluorometers that are commercially available.

The new technique is already generating interest from public health authorities and NGOs active in South Africa, India and the Gulf States.

“We expect to develop our base in the UK at Sci-Tech Daresbury, near Liverpool, so that we can manage all aspects of the business from there, including global logistics and international relationship management,” added Mr Norman.

TB is responsible for the deaths of some 1.4m people every year - or 3,800 people every day, half of them children - and is the world’s eighth biggest killer according to the World Health Organization. In 2009, there were almost 10 million orphan children as a result of the disease.

Sci-Tech Daresbury is a national science and innovation campus between Liverpool and Manchester which is regarded as one of Europe’s leading centers for innovation and business. It assumed official status in April 2012 as one of the UK Government’s flagship Enterprise Zones.

The site is a private-public sector joint venture between property company Langtree, the Science and Technology Facilities Council (STFC) and Halton Borough Council. The Universities of Lancaster, Liverpool and Manchester are active partners on the site.

John Downes, Group Chief Executive of Langtree and director of the Sci-Tech Daresbury Joint Venture Company, said: “Sci-Tech Daresbury’s position at the heart of the UK’s science and business community offers immeasurable assistance to businesses wishing to forge links with key partners such as the Wellcome Trust. We’re delighted to be able to play a role in developing something which might have such an important impact on the lives of millions of people.”