Cytovale Gets $9 Million in Federal Funding for Its IntelliSep Test for Sepsis

Cytovale, a San Francisco, Calif.-based company specializing in diagnostic tools to improve early detection of fast-moving and immune-mediated diseases, has received a total of $9 million in federal funding from the Biomedical Research and Development Authority (BARDA) to help bring its IntelliSep sepsis test to market.

The money is intended to help establish manufacturing readiness for IntelliSep, which produces diagnostic results in 10 minutes. The company first received BARDA funding for the test in 2019.

Cytovale is sponsoring a clinical validation study for IntelliSep at sites in Baton Rouge, La., Winston-Salem, N.C., Columbia, Mo., and Seattle, Wash. The study recently completed its target enrollment of more than 600 patients, and Cytovale is preparing the data from the study for inclusion in a 510(k) marketing submission for FDA clearance