Cytovale’s test gets FDA 510(k) clearance for early sepsis detection

Cytovale’s test gets FDA 510(k) clearance for early sepsis detection

Time Stamp: January 19, 2023 4:58 AM
Source Node: 1914802

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IntelliSep uses a standard blood sample to evaluate the cellular host response and identify patients with sepsis. Credit: Testalize.me / Unsplash.

Medical diagnostics company CytoVale has secured 510(k) clearance from the US Food and Drug Administration (FDA) for IntelliSep, its test for the early detection of sepsis.

IntelliSep has been designed to help clinicians recognise sepsis and make time-sensitive critical decisions. It provides test results within ten minutes.

It is claimed to be the first FDA-approved diagnostic tool for evaluating cellular host response to help identify patients with sepsis in emergency departments.

The emergency department-focused tool uses a standard blood sample to provide actionable answers directly.

It categorises the patients into three bands according to their probability of the condition.

Band 1 indicates a low probability, with the probability increasing through to Band 3.

Cytovale stated that the test results can help optimise clinical outcomes and improve hospital resource use.

The IntelliSep test was evaluated in a multi-centre clinical validation CV-SQuISH-ED study, which was completed early last year.

Findings from previous studies showed the potential of the test for detecting patients at increased risk of sepsis.

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.”

Using immune cell morphology, IntelliSep evaluates the immune response of the body to an infection.

Run on the Cytovale System, the test can provide valuable new insights related to sepsis.

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