Israel-based MeMed has reported positive results from a large multicentre prospective clinical trial validating the ability of its ImmunoXpert in-vitro diagnostic blood test to determine whether a patient has an acute bacterial or viral infection.
The company's assay decodes the body's immune response to accurately characterise the cause of the infection, compared to most infectious disease diagnostics that rely on direct pathogen detection.
In the trial, the ImmunoXpert immune signature was developed and independently validated on a group of 1,002 patients with acute infections showing highly accurate results, with sensitivity and specificity greater than 90%.
The assay was validated in a group of paediatric and adult patients at different time points after the onset of symptoms and across 56 different pathogen species.
MeMed CEO Eran Eden said: "Rapid, accurate and actionable diagnostic tools are an important part of the solution because they can aid physicians in making better informed treatment decisions."
By conducting screening of immune system proteins in patients with acute infections, researchers identified three soluble proteins that are uniquely activated by bacteria or viruses.
Following screening, the researchers developed proprietary algorithms that integrate these proteins to produce an immune signature that accurately identifies the cause of infection.
MeMed chief technology officer Kfir Oved said: "We conducted big data filtering, followed by extensive screening of 600 immune system-related proteins.
"A few of the proteins showed distinctly different patterns in bacterial and viral infected patients.
"In particular, the most informative protein we found, called TRAIL, dramatically increased in the blood of patients infected with a wide range of viruses, but surprisingly, decreased in bacterial infections.
"Our team developed an algorithm that computationally integrates TRAIL with other immune proteins to diagnose the cause of the infection with high accuracy."
The ImmunoXpert test is currently in pilot distribution in these territories, with a commercial launch scheduled for later in 2015. It is CE Marked and approved for clinical use in the EU and Israel.
Additional clinical trials are underway and the company is planning to conduct clinical trials in the US using a specially-designed point-of-care platform, which is currently under development.