FIND Backs Development of 3 Minute TB Test

Geneva-based Foundation for Innovative New Diagnostics [FIND], which is funded by the Bill & 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.

Proteome Systems’ 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.

Other tests that are currently available on the market such as T-cell-based assays and antibody-based assays, have lower sensitivity which is further reduced in patients who are immune-compromised (e.g. HIV-positive patients).

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 sect or in developing countries.

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

In March, the Sydney-based biotechnology company, Proteome Systems, won a $2 million Australian Federal Government R&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.