Press Release

July 2004
FIND to invest in visual TB test from SALUBRIS that cuts culture time in half

FIND, the Foundation for Innovative New Diagnostics, has added to its development portfolio of tuberculosis diagnostic tests, a novel tuberculosis colorimetric culture medium - TK MEDIUM®. (info)

FIND is investing in this technology together with the manufacturer, SALUBRIS, Inc. - the US based parent company of SALUBRIS GROUP.

TK MEDIUM®, developed by Dr. Tanil Kocagöz, represents an alternative to existing tuberculosis culture media. This innovative new product is inexpensive and cuts tuberculosis detection time in half, with speed of test results being comparable to expensive automated systems used in the developing world. The test uses multiple colour dye indicators that enable early visual detection of mycobacterial growth. TK MEDIUM® also permits drug susceptibility testing.

Only two technologies are widely available for detecting tuberculosis in the public sector of disease endemic countries - microscopy and to a lesser extent, culture. Culture methodology offers the advantage of being far superior to microscopy in terms of sensitivity, detecting nearly all cases of active tuberculosis. However, because of the slow growing nature of Mycobacterium tuberculosis, it takes 3-8 weeks for test results.

TK MEDIUM® indicates growth of mycobacterium by changing colour, eliminating the need to wait for colonies to become visually apparent on the culture media. Speed is enhanced by the medium's ability to detect the metabolic activity of the bacteria which changes the colour of TK MEDIUM® from red to yellow for a positive identification long before bacterial colonies appear. Additionally, this is the only rapid system available which differentiates mycobacterial growth from contamination - a colour change from red to green - without microscopic examination. "The speed of test results, simplicity and discriminating capacity should allow expanded use of this method to detect tuberculosis and improve the relevance of culture" said Dr. Mark Perkins, Chief Scientific Officer at FIND.

The TK MEDIUM® evaluation is being performed in collaboration between FIND and SALUBRIS to confirm its utility for tuberculosis case detection and drug susceptibility testing. The preliminary trials using this media are being performed in the U.S.A. and Turkey. Further clinical validation of TK MEDIUM® will be conducted in at least three different countries including the U.S.A. and South Africa.

"Collaboration with FIND will bring expertise, access to clinical trial sites and influence that will make it possible to move this technology forward so it may offer a real advance to developing countries," commented Dr. Kocagöz of SALUBRIS, Inc.

The methodology involved in the TK MEDIUM® can be used either manually or in automated systems making it appropriate for both developed and developing country laboratories. Investment from FIND will be used in development of prototype readers for automated systems used in incubating and reading the culture results. Rigorous large-scale evaluation of the technology is planned both in the United States and in developing country settings.

It is anticipated that evaluation of this new system will be completed within 18 months of commencement of the project.

Through the terms of this agreement, FIND and SALUBRIS will ensure affordability and accessibility of these tests for the public sector of developing countries.

FIND Diagnostics is a non-profit organization dedicated solely to the development of diagnostic tests for infectious diseases in developing countries.

SALUBRIS GROUP provides research & development, manufacturing, distribution and services in new and evolving technologies. SALUBRIS offers a range of products for the diagnosis of tuberculosis.

For more information visit:

www.finddiagnostics.org

www.salubrisinc.com

Contacts:

For SALUBRIS, Inc.:
Dr. Thomas SILIER, CEO
SALUBRIS, Inc.
One Broadway, Suite 600
Cambridge, MA 02142
U.S.A.
Tel: +33 147 41 28 88

For the Foundation for Innovative New Diagnostics:
Dr. Giorgio Roscigno, CEO
FIND
71 av. Louis Casaï, PO Box 93
CH-1216 Cointrin/Geneva
Switzerland
Tel: +41 22 710 0590

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