Cytovale has secured the US Food and Drug Administration (FDA) 510(k) clearance for its IntelliSep test to be used in the early detection of sepsis.

IntelliSep is a diagnostic tool designed to aid clinicians in recognising sepsis. The test is said to support in making critical clinical decisions that are time sensitive by delivering test results in less than 10 minutes.

From a standard blood draw, the test is claimed to give actionable answers.

According to Cytovale, patients are categorised into three bands by IntelliSep as per their probability of sepsis. Band 1 indicates less chances of sepsis and Band 3 indicates the opposite.

Results derived from the test could give providers a tool for optimising clinical outcomes and help hospitals to better use their resources.

Cytovale co-founder and CEO Ajay Shah said: “This clearance is a pivotal step forward in Cytovale’s commitment to early detection technologies to improve health.

“Every minute is crucial in identifying sepsis, and IntelliSep has the potential to transform clinical approaches to sepsis triage and diagnosis and save countless lives.”

A multi-center clinical validation study on the test called CV-SQuISH-ED which was completed in early 2022, is getting ready for publication, said the medical diagnostics company.

Cytovale said that the findings from previously published studies show the 10-minute test’s potential in helping physicians quickly identify patients at higher risk of sepsis.

IntelliSep’s technology, runs on the Cytovale System, and evaluates the body’s immune response to an infection with immune cell morphology. By putting pressure on tens of thousands of cells and seeing their reaction, the test can deliver valuable new insight about sepsis, said the company.

The diagnostic tool will be launched in the coming weeks in the US.