Cytovale System IntelliSep test
The Cytovale System on which the IntelliSep diagnostic is run. [Image from Cytovale’s website]

Cytovale announced today that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test.

San Francisco-based Cytovale plans to use the funds to further expand the reach of its FDA-cleared IntelliSep sepsis test. The FDA cleared IntelliSep, which aids hospital emergency departments and health systems, in January.

IntelliSep provides test results in under 10 minutes, offering actionable answers using standard blood draws. The emergency department-focused tool helps clinicians recognize sepsis and make time-sensitive critical decisions. It can also integrate into existing emergency department workflows.

Using a unique approach, IntelliSep assesses the body’s immune response to an infection by interrogating immune cell morphology and mechanics. It “squeezes” white blood cells and characterizes their responses.

The diagnostic categorizes patients into three bands according to their probability of sepsis. Band 1 indicates a low probability of sepsis and the probability increases through Band 3. These results can help optimize clinical outcomes and improve hospital resource utilization, Cytovale said.

Cytovale began working with select early access hospitals and health systems to implement IntelliSep. Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, became the first to implement it in August.

“Sepsis is a dangerous, fast-moving condition that can result in death if not identified and treated quickly,” said Cytovale CEO Ajay Shah. “Our flagship diagnostic tool, IntelliSep, with a blood-to-answer time frame of under 10 minutes, helps healthcare providers recognize sepsis early and make critical, time-sensitive clinical decisions. With the support of our investors, we are now able to expand efforts to get our tool in the hands of more providers so they can address the potential deadly outcomes patients currently face.”