Inspector01

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

Landscape