The iFAST ONE ultra-rapid Antimicrobial Susceptibility Test (AST) system is now UKCA Certified for testing patient samples, direct from Gram-negative bacteria blood cultures.
Clinicians in hospitals throughout Great Britain can now use data from iFAST Diagnostics to prescribe the most suitable antibiotics for individual patient infections, which will save thousands of lives, shorten hospital stays and help the fight against antimicrobial resistance (AMR).
The iFAST system can deliver high-throughput AST results to clinicians in under three hours, at costs comparable to the current standard of care, but up to two days faster. This enables clinicians to determine and prescribe the optimal antibiotic to the sickest patients, all within a single working shift.
Dr Toby King, CEO, iFAST Diagnostics commented: “We are super excited to have achieved our UKCA mark. As we go to market, hospitals using our system will have access to AST results in under three hours, instead of 24-48 hours, massively improving the outcome for thousands of patients, especially in increasingly critical areas such as sepsis and multi-drug-resistant infections, all without increasing the overall cost of the testing. To have achieved this within three years of founding the company is astonishing, and testament to the ability, dedication and hard work of our amazing founders Hywel Morgan and Daniel Spencer, and the entire iFAST team.”
The news follows on from recently completed clinical trials of the iFAST ONE which saw the testing of 374 Gram-negative bacterial samples of seven different species at three UK sites: Portsmouth, Southampton, and Bristol.
The seven species (including those responsible for most cases of life-threatening infection and sepsis, such as Escherichia 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.
Results achieved by the iFAST ONE were: 98.3% specificity; 96.3% sensitivity, and 96% reproducibility. For routine clinical use, these results validate the manufacturers’ claim to consistently give accurate, rapid AST results, from a positive blood culture, in under three hours.