Increased support for the development of needed TB diagnostic tests

FIND and WHO/TDR agree to expand access to TB specimens

Geneva, Switzerland – 19 March 2013 – FIND, the Foundation for Innovative New Diagnostics, and TDR, the Special Programme for Research and Training on Tropical Diseases, have joined forces to increase access to clinical reference materials needed in the development of diagnostics for tuberculosis (TB). Currently, there are no point-of-care tests recommended for use by the World Health Organization. As a result, TB often goes undiagnosed in people who do not have easy or close access to health care facilities, leading to untreated cases and avoidable deaths.“This new collaboration should accelerate the development of the point-of-care diagnostic tests that meet quality standards,” said TDR Director John Reeder.

Academic and industry groups working on developing tests for tuberculosis are often stymied by the lack of sputum, serum, and other specimens needed for product development and validation. The TDR-TB Specimen Bank, which was launched in 2000 and has been refreshed on an ongoing basis ever since, contains samples from symptomatic respiratory patients with and without TB, collected from over a dozen geographically diverse countries.

The new agreement is an important evolution that allows FIND to expand access to these materials by leveraging its biobanking capacity and connections to diagnostic research organizations and manufacturers. It will take over daily management of the bank and work with TDR to support increased use of the samples.

“Sample access has always been a critical bottleneck in the development and evaluation of new diagnostics for TB”, said Mark Perkins, Chief Scientific Officer of FIND. “We are pleased to support TDR to maintain and distribute these precious materials, and believe that establishing a simple and centralized facility through which they can be accessed can stimulate additional test developers to work in this field”.

The two organizations will provide open access to the samples of sputum, serum, saliva and urine collected in prospective studies, supported with a full microbiologic examination and clinical follow-up. Materials are frozen on-site and maintained deep-frozen at a central distribution site. Each sample is linked to detailed clinical and microbiological information.

All requests will undergo a rapid process of review.