High accuracy, low blood volume test for bacterial sepsis


A host-directed diagnostic methodology, which uses only 10-50 μL of whole blood, and enables rapid and accurate detection of sepsis in neonates and other subjects. The test removes false negative results associated with current gold standard microbiological methods. Since the test is highly specific for microbial infection, it reduces antibiotic usage.

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APPLICATION

Diagnosis of bacterial sepsis in neonates, infants, children, and adults across all ethnic profiles

Monitoring treatment response to antibiotic treatment

DEVELOPMENT STATUS

Up to 98% accuracy with as few as 4 gene markers

Validated across three microarray platforms using clinical samples

‘Blind validated’ on potential false negative samples

Ongoing validation on additional platforms (e.g. qPCR, sequencing).

IP STATUS

National patents filed (EP and US) (WO 2015/155517 A1)

COMMERCIAL OFFERING

Licensing and/or co-development

OPPORTUNITY


Current treatment protocols for sepsis in vulnerable patients oblige administration of broad-spectrum antibiotics at the first clinical signs. This leads to unnecessary antibiotic use, can cause liver problems, bacterial resistance, and may adversely affect the developing microbiome in vulnerable patients. Furthermore, the current blood culture protocol requires a large blood sample draw, takes 2-4 days to confirm a diagnosis, and is susceptible to high false negative results due to the reliance on pathogen detection. An improved diagnostic tool for sepsis is therefore required.

TECHNOLOGY


A team lead by Professor Peter Ghazal has developed a new assay, based on monitoring up/down-regulation of a small panel of host pathway markers using different, commercial multiplex platforms. It is rapid (hours to diagnosis); sensitive and specific for microbial infection (reducing unnecessary antibiotic usage); only uses a small sample volume (10-50 μL whole blood) and reduces false negatives.

The marker panel was initially validated using a combination of statistical analysis and empirical measurement in an index group of 62 patients with confirmed blood-positive sepsis, showing 98% accuracy. It was further validated on independent patient samples and shown to be consistent across several different expression platforms. The marker set has also been ‘blind validated’ for clinical utility, using samples from clinically suspected cases of sepsis that tested negative by cell culture (possible false negative samples). Further studies (350 cases, across three separate African / European studies) have confirmed it also provides robust and accurate detection of sepsis in children, infants and adults.

BENEFITS


  • Provides accurate and robust detection of sepsis
  • High reliability, and reduction of false negative results
  • Improved diagnosis time, as fast as ~ 2 hours, depending on platform
  • Minimally invasive blood analysis from neonates to adults

PUBLICATION


Nat. Commun. 5:4649 doi:10.1038/ncomms5649

Genomics Data 3 (2015) 41–48, doi:10.1016/j.gdata.2014.11.003

Please note, header image is purely illustrative.

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