Clinical Trials bring iFAST closer to launch
iFAST Diagnostics Ltd have successfully completed their pivotal clinical trials and as a result are another step closer to UK market launch.
The team tested 375 Gram-negative bacterial samples of 7 different species at three UK sites – Portsmouth, Southampton, and Bristol.
The 7 species (including those responsible for most cases of life-threatening infection and sepsis, such as E. coli and Pseudomonas Aeruginosa) were tested against a range of 16 drugs, making a total of almost 5,000 data points. The iFAST results were compared with the ‘gold standard’ method, broth microdilution, as well as being tested for reproducibility, with the target for regulatory approval being a minimum of 95% in all cases.
The headline results are:
- 98.3% specificity
- 96.3% sensitivity
- 96% reproducibility
For routine clinical use, these results validate our claim to consistently give accurate, rapid AST results, from a positive blood culture, in under 3 hours.
iFAST Diagnostics, 1500 Parkway, Whiteley, Hampshire PO15 7AF, United Kingdom
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