Contract Option to Support Manufacturing Ramp-up to Enable Commercial Launch Preparations
Cytovale™, a medical diagnostics company focused on providing rapid and insightful tools to improve early detection of fast-moving and immune-mediated diseases, 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. This latest contract action, aimed at helping to establish manufacturing readiness of IntelliSep for launch, provides total funding of $9 million.
“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”
Originally awarded in 2019, the contract provides manufacturing ramp-up support for the launch of IntelliSep, once a U.S. Food and Drug Administration (FDA) 510(k) clearance of the product is obtained. In the IntelliSep clinical validation study, investigational systems were placed at clinical study sites in Baton Rouge, La.; Winston-Salem, N.C.; Columbia, Mo.; and Seattle, Wash. The study recently fulfilled the target enrollment of more than 600 patients and Cytovale is actively preparing the data from the study for inclusion in a forthcoming 510(k) submission to FDA.
“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.”
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 mortality1. These data demonstrate the 10-minute test’s potential to aid physicians in rapidly identifying patients at increased risk of having or developing sepsis2, a dysregulated immune (white blood cell) response to infection, which is highly lethal and difficult to quickly and accurately diagnose.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50119C00072.
About Cytovale
Cytovale is a medical diagnostics company focused on providing rapid and insightful tools to improve early detection of fast-moving and immune-mediated diseases. Cytovale’s investigational IntelliSep test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient’s risk of sepsis. The test is designed to quantify the state of immune activation by measuring the biophysical properties of leukocytes from a routine blood sample in under 10 minutes. For more information, please visit www.cytovale.com. For updates, follow Cytovale on LinkedIn and Twitter.
1 Guillou, L. (2021). Development and validation of a cellular host response test as an early diagnostic for sepsis. PLOS ONE, April 15, 2021. https://doi.org/10.1371/journal.pone.0246980
2 O’Neal, Hollis R. Jr., et al. (2021). Assessment of a cellular host response test as a sepsis diagnostic for those with suspected infection in the Emergency Department. Critical Care Explorations. https://journals.lww.com/ccejournal/Fulltext/2021/06000/Assessment_of_a_Cellular_Host_Response_Test_as_a.27.aspx
