FIND and Biotec Announce Development of New Test for Rapid Diagnosis of Multi-Drug Resistant TB

The Foundation for Innovative New Diagnostics (FIND) and Biotec Laboratories Ltd. (Biotec) today announce completion of the development of FASTPlaque-Response,a new diagnostic test for multi-drug resistant TB that provides results in just two days, a significant improvement over conventional methods which take weeks to yield results.

This new product is a result of public and private collaboration between FIND and Biotec.

“We are extremely pleased with the first outcome of our collaboration with FIND,” said Peter Ellis, CEO of Biotec Laboratories Ltd., which has registered the test in Europe. “This new test will give clinicians the opportunity to effectively manage a patient’s treatment at the time of diagnosis, rather than using a standardized treatment in the hope that they got it right.”

FASTPlaque-Response is able to detect resistance to the critical TB drug Rifampicin directly from the sputum of patients with advanced tuberculosis, with accuracy comparable to current conventional methods. Rifampicin resistance indicates a high chance of multi-drug resistant (MDR) TB, which is often fatal if incorrectly diagnosed and treated. Some 450,000 people are thought to develop MDR-TB, worldwide, each year. The test works by using mycobacteriophage (virus that infect TB) to reflect the presence of viable TB bacilli within a sample.

“It is critical that we are able to identify patients who are infected with TB bacteria that are resistant to current treatment regimens before they transmit the disease or are beyond the ability to respond to available treatments,” said Dr. Giorgio Roscigno, CEO of FIND. “Without effective diagnostics, identifying MDR-TB is largely guess-work, and patients are either treated inappropriately with expensive and toxic therapies they do not need and cannot afford, or fail to get specialized treatment,” he added.

The new test will cost less than one tenth of the cost of the more technically demanding molecular tests, the only other rapid test for MDR-TB currently available on the market. The product has received regulatory approval within Europe. Biotec is about to launch the new test globally, with the initial focus in countries with a known high disease burden, such as Eastern Europe, Russian Federation, Central Asia, India, China and South Africa.

"Data published to date suggest that the test is both fast and accurate," said Dr Mark Perkins, Chief Scientific Officer of FIND. "With the completion of a current large clinical study in Lima, Peru," he continued, "we expect to have an excellent understanding of test performance in controlled settings. FIND plans to further evaluate this technology through large-scale demonstration projects, which assess the feasibility and impact of using the test in the public sector of low-income countries."

Once these projects are completed, the test will be made available for the public sector of developing countries at concessionary prices, as ensured by an agreement signed between FIND and Biotec.