NEW YORK ─ Cytovale on Tuesday announced it has received additional funding from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the manufacturing ramp up of its 10-minute IntelliSep sepsis risk stratification test, bringing its total BARDA funding to $9 million.
The contract would also support the commercial launch of IntelliSep if Cytovale obtains a US Food and Drug Administration 510(k) clearance for the platform, the firm said. Cytovale said it is preparing data from a 600 patient study for an FDA submission.
In 2019, the San Francisco-based firm announced it had obtained a BARDA contract valued at up to $7.6 million.
Cytovale's platform uses biophysics as a basis for its tests; its core technology analyzes the mechanical properties of single cells to understand cell state and behavior.