The firm will scale US-based testing capacity for its LiquidHallmark liquid biopsy assay, which uses amplicon-based technology to detect cancer-related mutations.
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.
The University of Utah spinout said it will use the funding to enhance and expand its NGS-based Explify microbe identification platform and support its lab.