Background

Currently, pathogenic microorganisms are IDed on “post culture positive” samples via their phenotype. The process involves growth on a blood-agar plate to isolate the organism, creation of a suspension of bacteria, and running a series of reactions to test for the production/consumption of specific proteins/enzymes.  Each one of these reactions are specific to certain types of bacteria.  The process can take over 24 hours.  Because they are run on blood culture positive samples, the final results are too slow to impact patient care.
Some newer tests provide for faster ID of the bacteria (via rapid PCR tests) or faster ID and AST via microscopic observations of growth.  But even so, these faster test results come in about 12 hours after the blood culture positive, and have a marginal impact on patient outcomes.  And they are very expensive.
Our BloodFAST test provides for rapid ID and AST of the blood culture positive samples in 2.5 hours, and is relatively inexpensive compared to the PCR type tests.  The test identifies most of the commonly observed bacteria in bloodsteam infections (covering about >95% of all cases), and provides AST information against a panel of 22 candidate antimicrobials.

Our Approach

We characterize the bacteria phenotype via color change reactions. This is the same approach taken by conventional phenotyping instruments; but we are able to do so without requiring a concentrated suspension of bacteria.   

Nominally, these color changes are very difficult to read, particularly when the changes are small and hidden in a complex background.  Our IP enables the accurate readout of these changes.  Accordingly, we are able to characterize the phenotype of the bacteria at very small concentrations.  We test multiple reagents (12 in all) in parallel using a “96 well plate”.  The other 84 wells in the 96 well plate are taken up by 7 serial dilution concentrations of 12 candidate antibiotics (selected to provide coverage against both Gram Positive and Gram Negative organisms).

Our methods can characterize the phenotype of the test organism, and characterize its response to the 12 antibiotics in about 6-8 hours. 

Current Status

We have submitted a QSub to the FDA with questions on the regulatory path.  We are hoping to see this tool on the market in 2022.  For Research Use Only applications, please send us an inquiry