1Treatment
Antibiotic selection and changes in treatment
Whether earlier results change antibiotic selection, and when treatment changes occur.
Evidence and development
What three years in a hospital laboratory established, and what comes next.
The Saskatchewan programme measured analytical performance and turnaround on patient specimens. A proposed clinical study would examine effects on treatment decisions, hospital stays and costs.
The pilot
Laboratory evaluation at Royal University Hospital, Saskatoon.
The Royal University Hospital evaluation formed part of a three-year Saskatchewan laboratory programme. The figures below are programme totals. The work measured analytical performance and turnaround; it did not establish effects on patient outcomes.
3 yearsJoint laboratory programme in Saskatchewan, 2021 to 2024
1,400+Urine samples collected in 2021 and 2022, including 429 culture-positive
226Positive blood cultures
What it established
The chemistry works on real patient specimens.
Bacterial identification and antibiotic susceptibility results on more than 1,400 urine samples and 226 positive blood cultures, produced inside a hospital laboratory by laboratory staff, alongside the conventional culture workflow.
What changed
A new instrument platform.
The legacy instrument used in the programme proved unreliable. The assays have since been moved to the Luminex LX200, an analyser already cleared for clinical laboratory use and installed in many laboratories. Assay performance on the new platform, including for the species where sensitivity was lower, is the subject of the validation work now under way.
What it did not answer
What the speed is worth.
The programme measured analytical accuracy and turnaround. It did not measure admissions, length of stay, antibiotic use or cost. A prospective emergency-department study is proposed to measure exactly that.
Analytical performance under study conditions on the legacy instrument, not a clinical outcome claim. Specimen counts per the joint programme record, May 2024 analysis.
Turnaround
Time to a result, measured.
Hours from the specimen reaching the laboratory to a reportable result, for urinary tract infection, measured in the pilot alongside the conventional workflow. Both bars share one scale.
Time to an answer
TodayConventional culture
With MicrobeDXRapidID + RapidAST
| Workflow | Bacteria identified | Antibiotic susceptibility |
|---|---|---|
| Conventional culture | about 35 | 40 to 171 |
| MicrobeDX | about 2.7 | about 5 |
Accuracy
Performance varies by bacterial species.
Urine
Across the culture-positive urine samples, the assays identified the common urinary pathogens with high specificity. Sensitivity was strongest for the most frequent organism, E. coli, and lower for some less common species, particularly where more than one species was growing or the bacterial load was low.
Positive blood cultures
Across the reported blood-panel targets, sensitivity and specificity were high. Some bacteria were detected without species-level identification.
Detailed results
Per-species sensitivity and specificity, sample counts and the study protocol are available to qualified laboratory, clinical and investment partners on request, under a confidentiality agreement.
Joint May 2024 analysis on the legacy instrument. Results on the current platform are the subject of the validation work now under way.
The next study
From a faster result to a measurable benefit.
A prospective emergency-department study is proposed to connect diagnostic turnaround with clinical decisions and resource use. It would measure four things.
2Disposition
Admission and discharge decisions
Whether an earlier answer changes who is admitted, who goes home, and when.
3Capacity
Hospital and ICU bed-days
Whether shorter diagnostic waits reduce avoidable bed-days for patients with serious bacterial infection.
4Cost
Health-system costs and resource use
What the change in treatment, disposition and bed-days is worth to the system that pays for them.
MicrobeDX makes no claim about mortality, length of stay, bed-days or cost savings attributable to its own assays. Published results for other rapid diagnostic technologies are not MicrobeDX outcomes.
Development status
Current development status.
Regulatory status
MicrobeDX's assays are investigational and are not licensed by Health Canada for routine clinical use.
Next steps
Platform-specific validation on the Luminex LX200, planned under a quality-management framework, prospective clinical evaluation, and the applicable regulatory pathway. No commercial availability date is stated here.
Governance of this page
Figures and wording follow the claims boundaries in MicrobeDX's August 2026 materials and remain subject to technical and regulatory review before public release.