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 currently available tests 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 (they take 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 exploit the unique properties of human serum albumin (HSA) with incorporated lycopene to sense and characterize pathogenic microorganisms at clinically relevant concentrations with a rapid (<20 minutes) test.   We characterize the free radicals produced by pathogenic microorganisms, via their effect on serum albumin (in our proprietary reagent).

We characterize this free radical production as a surrogate for pathogen metabolic activity.  Our methods have a demonstrated ability of detecting over 30 different microorganisms (covering most reported cases of bloodstream infection), with a demonstrated limit of detection below 10 CFU/mL.   Our methods have also been shown (in multiple clinical studies) 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


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.
InSpector-01 CompLandscape