Three-minute diagnoses from TB lab test
waiting time from 24 hours to three minutes using a technique that
identifies TB antigens, has been made available by Proteome
Systems. The application is set to raise the standards of tests
currently available on the market, which suffer from low
sensitivity.
Tuberculosis (TB) is a highly contagious disease that currently infects over 33 per cent of the world's population. Its spread has been exacerbated by a variety of reasons, one of which includes the large numbers of people from all over the world who travel.
Coupled with the worldwide rise of multi-drug resistance TB strains and the global spread of HIV, estimates of TB in HIV-infected patients are thought to be 25-50 times that of HIV-negative patients.
Proteome Systems' test detects TB antigens indicating active TB infection in the human body. The test monitors 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.
Proteome Systems' TB test has been designed to function through a point-of-care (POC) system, delivering results within minutes. Jenny Harry, head discovery & 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."
Such is the necessity of this test that Proteome Systems has signed a letter of intent with The Foundation for Innovative New Diagnostics (Find) to fast-track the development of this diagnostic application.
According to Proteome's CEO, Stephen Porges, the partnership with Geneva-based 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.
Treatment is desperately needed in the developing world, with poor infrastructure like roads and communications, it can be up to six months until people receive the treatment they need.
Traditional laboratory methods of detecting active TB (e.g, 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 currently available on the market include 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 (e.g, HIV-positive patients). Additionally, the speed of the test and need for laboratory conditions further reduce their efficacy.
The HIV-AIDS epidemic sweeping across many parts of the world is making matters worse since the killer disease often triggers the latent TB, which is carried by an estimated one in three of the world's population.
Even in the developed world, one out of 20 carry the TB bacillus. In some developing countries, one in two people are infected. A carrier of latent TB has a 10 per cent life-long risk to develop TB. However, in HIV patients, that risk is 10 per cent per year.
The Global Alliance for TB development estimates the TB market size will grow from around $440 million (€354 million) in 2000, to almost $700 million by 2010, and although this represents a comparatively small market size, careful product placement and market strategies could drive a more significant growth in the market.
