One of the current challenges in the clinical microbiology field is the emerging antibiotic resistance problem in pathogenic bacteria. Some of the major areas affected due to antibiotic resistance are point-of-care labs, hospitals, agriculture, food, and dairy industries. The current assays can detect the susceptibility and resistance but are time-consuming and take 1-3 days starting from the sample processing to obtaining results.
As part of the service agreement for its client CytoSPAR, InfinixBio assisted with the development of a novel antibiotic susceptibility diagnostic assay that outperforms the traditional methods in terms of time and sensitivity. The work started with the proof of concept where InfinixBio was involved with the development of an assay that is now being converted into a laboratory-developed test (LDT).
The challenge of building this assay started with determining the right reagents and instruments for the test. Then we needed to test methods for data interpretation and perform process optimization to ensure the outcomes were as good or better than the gold standard testing procedure. Importantly, a key challenge was to reduce the overall assay time so that it could be completed within a work shift by following a simplified workflow and minimum hands-on time.
InfinixBio not only made the detection and result prediction faster but also assisted with enhancing this assay so it can also be used for analyzing the effect of different antibiotics on multiple pathogenic strains. During this program, InfinixBio was the central contractor, coordinating and collaborating with multiple vendors, technology partners, manufacturing companies, KOL’s, and testing laboratories based on the client’s preferences and needs.
InfinixBio has played a pivotal role in the validation of this unique technology and continues to assist this client with regard to achieving regulatory and commercialization goals.
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