A novel test designed to quantify the state of immune activation by measuring the biophysical properties of leukocytes from a routine blood sample in less than 10 minutes is pioneering a new way of quickly and accurately stratifying a patient’s risk of sepsis.

Cytovale (San Francisco, CA, USA), a medical diagnostics company focused on providing rapid and insightful tools to improve early detection of fast-moving and immune-mediated diseases, is preparing for the commercial launch of its 10-minute IntelliSep sepsis risk stratification test.

Data from previously published studies have shown that Cytovale’s IntelliSep test quickly and clearly distinguished mortality risk in a high-acuity population and accurately identified patients with infections severe enough to cause morbidity and mortality. These data demonstrate the 10-minute test’s potential to aid physicians in rapidly identifying patients at increased risk of having or developing sepsis, a dysregulated immune (white blood cell) response to infection, which is highly lethal and difficult to quickly and accurately diagnose.

Cytovale has received additional funding from Biomedical Research and Development Authority (BARDA) to help advance the company’s 10-minute IntelliSep sepsis risk stratification test towards commercial launch. Originally awarded in 2019, the contract provides manufacturing ramp-up support for the launch of IntelliSep, once a US Food and Drug Administration (FDA) 510(k) clearance of the product is obtained.

“This execution of the final option in the contract will help us complete manufacturing ramp-up as we prepare to launch our IntelliSep test, making a reality of our vision for a critical, time-saving tool with the potential to change the way emergency departments recognize and treat sepsis,” said Cytovale co-founder and CEO Ajay Shah. “In addition to the financial investment, we believe the funding underscores the importance of these final manufacturing activities necessary to bring IntelliSep to market to address an unmet need and help physicians more quickly and accurately assess patients who may have this deadly and debilitating condition.” 

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