Tyrian Diagnostics Limited (Tyrian) announced that Tyrian and Becton, Dickinson and Company (BD) will not continue their collaboration to develop a Point-of-Care (PoC) test for the diagnosis of active tuberculosis (TB).
In January 2009, Tyrian reported that its lead TB marker was detected in clinical strains of the bacteria responsible for TB as well as in clinical sputum samples; however, it was unable to detect the marker at the desired levels of sensitivity and specificity.
In May 2009, Tyrian granted BD research and development rights to conduct further feasibility studies using its proprietary technology to seek to achieve the desired levels of sensitivity and specificity for an effective PoC diagnostic product. Neither company was able to consistently detect the Tyrian lead biomarkers in clinical samples at a level of detection required for a rapid test to be effective.
Dr Jenny Harry PhD, Tyrian CEO, commented that “We acknowledge further advances in the available technology are required for the development of a sensitive 5 minute test to detect active TB. While we are disappointed not to be proceeding with BD on a proteinbased PoC test for TB using our biomarkers at this time, this outcome has two positive aspects for Tyrian.
Firstly, it validates our decision to focus on the development of a molecular diagnostic test for active TB using our patented markers, since molecular technologies are well established and currently much more sensitive than protein-based technologies”.
Tyrian is currently working with Dr Barry Kreiswirth, Director of the Public Health Research Institute TB Centre, New Jersey, to validate its patented biomarker and establish a sputum-based assay using existing molecular technology. This will pave the way for a molecular TB test to be developed in partnership with a company that offers a platform appropriate for use in TB testing environments.
Whilst molecular testing should have the sensitivity required for detection of active TB, it is performed in a clinical setting and so meets only a part of the market need. There is still an urgent requirement for a simple, rapid test which is easily deployed at point of care.
“Secondly, we now believe that, among participants in this field, Tyrian arguably holds the best portfolio of biomarkers for a PoC TB test. We are in an excellent position to team with a new partner as an appropriate, sensitive and commercially viable technology emerges” announced Dr Harry.