Fast-track funding for rapid TB diagnostic test

The Foundation for Innovative New Diagnostics (Find), which is funded by the Bill and Melinda Gates Foundation, has signed a letter of intent with Australian biotechnology company Proteome Systems to fast-track the development of a rapid antigen-based diagnostic test for the detection of active tuberculosis (TB).

TB is the most prevalent infection in the world today - a third of the world's population is infected, and two million people die of TB every year.

The difficulty in treating TB is that the airborne disease can often spread more quickly than it can be identified, limiting the effectiveness of treatments.

Proteome Systems's test will detect TB antigens indicating active TB infection in the human body.

The test will also monitor disease progression and response to treatment in patients with TB regardless of the immune status of the host - for example TB patients with HIV co-infections.

The collaboration with Find was announced at Bio 2005 in Philadelphia by Peter Baxter, charge d'affaires, Australian Embassy, Washington DC.

Among those present were Giorgio Roscigno (CEO of Find), Hannah Kettler (Bill and Melinda Gates Foundation), Marcos Espinal (executive secretary, Stop TB Partnership, affiliated to the World Health Organisation), and Stephen Porges (CEO of Proteome Systems).

Giorgio Roscigno, CEO of Find, said: "the Proteome Systems team has used its unique biomarker discovery platform and skills to distinguish TB proteins in infected people.

"These biomarkers pave the way for the TB test Find has been working to develop".

According to Proteome's CEO, Stephen Porges, the partnership with Find will provide the critical support to speed the development of the test in addition to clinical material, assistance with clinical trials and fast tracking of registration, in return for exclusive royalty-free rights to distribute the product in the public health sector in developing countries.

Proteome Systems's TB test would be an easily administered, point-of-care (POC) system, delivering an accurate result within minutes.

Jenny Harry, head discovery and diagnostics at Proteome Systems, said: "Unlike most currently available TB diagnostics, the new test would directly detect proteins expressed by the TB causative microbe mycobacterium tuberculosis in infected individuals, as well as measuring the severity of an infection.

"In this age of spectacular advances in biotechnology it is outrageous that developing countries must rely on a 100 year-old test to diagnose tuberculosis".

"With TB on the increase, quicker and more reliable tests are a top priority to control the spread of the disease, particularly in TB/HIV settings," according to Peter Small, Find board member representing the Bill and Melinda Gates Foundation.

Marcos Espinal, from the WHO's Stop TB Partnership, said: "TB is one of the greatest threats to global health today.

"We are delighted to hear of Proteome's partnership with Find, lead agency in our Diagnostics Working Group, as it works on developing the next generation of TB tests".

Proteome Systems has intellectual property in the following areas that are key to development of a TB diagnostic test: unique technology for screening and validation of markers leading to the identification of in vivo-expressed M tuberculosis proteins; a rapid diagnostic platform for the screening of different types of biological fluids such as sputum, saliva, plasma or whole blood.

In March 2005, Sydney-based biotechnology company Proteome Systems won a A$2 million Australian federal government R and D Start grant to advance development of its new diagnostic for tuberculosis in a laboratory format.

Now the company has formed an international alliance that will see a rapid point-of-care format completed by late 2005, with the test then being fast-tracked through clinical trials.

Background on TB: tuberculosis (TB) is a highly contagious disease that currently infects over 33% of the world's population.

The spread of TB has been exacerbated by (i) the large numbers of people from all over the world who travel; (ii) the worldwide rise of multi-drug resistance TB strains; (iii) the global spread of HIV, with estimates of TB in HIV-infected patients being 25-50x that of HIV-negative patients.

Traditional methods of detecting active TB (eg, smear and culture) suffer from procedural difficulties, lack of sensitivity and specificity, and cost constraints that limit their application in many parts of the world.

Other tests are currently available on the market such as T-cell-based assays and antibody-based assays.

The sensitivity of these tests tends to be low, and is further reduced in patients who are immune-compromised (eg, HIV-positive patients).

The speed of the test and need for laboratory conditions further reduce their efficacy.

The HIV pandemic has led to a resurgence of TB as a major public health problem.

Immunodeficient HIV-positive patients are particularly vulnerable to TB, which is responsible for the deaths of at least 40% of patients in this group.

About Find: the Foundation for Innovative New Diagnostics (Find) was launched at the World Health Assembly in May 2003 and was registered two months later as a non-profit Swiss foundation based in Geneva.

Its purpose is to support and promote the health of people in developing countries through the development and introduction of new but affordable diagnostic products for infectious diseases.

Background on Proteome Systems: Proteome Systems discovery and diagnostics business discovers protein biomarkers that have potential for use as diagnostics and therapeutic targets in the areas of respiratory disease, neurobiology and aging and cancer.

With the recent acquisition of Eukarion, the discovery and diagnostics business has a portfolio of drugs entering clinical development.

Proteome Systems Technology business develops and commercialises innovative technology solutions to enable proteomics and glycomics research.

These solutions include integrated instrument-based systems, consumables and bioinformatic software.