Inspector-01

/Inspector-01
Inspector-01 2018-06-16T19:30:01+00:00

Background

Pathogenic microorganisms at concentrations of 1-10 CFU/mL in the bloodstream can trigger sepsis, thus symptoms consistent with the presence of these microorganisms warrant treatment with antibiotics. There are no tests currently available that can characterize these microorganisms in a timely manner — the only available method for this is based on blood culture, which is too slow to influence initial therapy (it takes 12-48 hours for a culture positive flag and 120 hours for a culture negative flag). At 10 CFU/mL, the pathogen’s net weight is about 108 less than the cumulative weight of other plasma proteins, thus any detection mechanism requires significant amplification. Historically, this amplification has been provided by a culture method whereby the pathogenic microorganisms are given the time to replicate to > 106 CFU/mL. For most samples, it takes 24-72 hours for significant cell growth, and the absence of growth at 120 hours results in a “culture negative” diagnosis.  

Our Technology

We sense and characterize pathogenic microorganisms at clinically relevant concentrations with a rapid (<20 minutes) test. Our methods have a demonstrated ability of detecting over 30 different microorganisms (covering most reported cases of bloodstream infection), with a limit of detection below 10 CFU/mL. Our methods have also been shown (in multiple clinical studies, described below) to be applicable to patient samples, and have a good concordance with standard blood culture results.

Current Status

A Qsub to the FDA for this tool was submitted in January 2018.  

We anticipate initial commercialization in central laboratories of hospitals in the US and EU. The initial application will be screening of blood draws in patients who are potentially infected, so as to accelerate the initiation of pathogen characterization tools on samples that are screened as infected. Additional applications will be added in the future as warranted by additional development.

We have validated this tool with a number of pilot studies around the world, with performance parameters described below

Pilot Site Year Sensitivity Specificity
Site 1 2011 1(0.86-1) 0.83 (0.66-0.93)
Site 1 2012 1 (0.7-1) 1 (0.93-1)
Site 2 2015 1(0.85-1) 1 (0.80-1)
Site 2 2016 0.46(0.2-0.74) 1 (0.87-1)
Site 3 2016 1 (0.52-1) 0.82 (0.65-1)
Site 3 2017 1 (0.2-1) 0.94 (0.78-0.99)

Landscape

How does the InSpector-01 tool compare to the current landscape?

 Currently, all pathogen characterization tools are initiated on blood culture positive samples only. Thus, the average time to result (from the blood draw) is about 54 hours. Other tools in development will speed up the “post-culture” analysis, and it may be possible to develop pathogen characterization information in 19-24 hours (which is in time for the 5th antimicrobial dose). By contrast, our InSpector-01 tool, even when combined with existing pathogen characterization tools, will reduce that timeline to 5-10 hours (in time for the 2nd or 3rd antimicrobial dose).And if combined with our InSpector-02 and InSpector-03 tools, then the pathogen characterization information will be available within 5 hours ~ in time for the 2nd antimicrobial dose.

The Future of Clinical Microbiology

Following a “blood culture positive”, the isolated bacteria are subject to a battery of tests that identify them, and characterize their response to various candidate antimicrobials. This process is very labor intensive, and it also delays therapy optimization, which negatively impacts patient outcome.
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