Dec. 9 Quick Takes: $67.5M A round for liquid biopsy play Exai

A $67.5 million series A round will help Exai Bio accelerate development of its non-invasive, RNA-based liquid biopsy technology for early cancer detection. The San Francisco company’s technology is based on research conducted by co-founder and adviser Hani Goodarzi, who is an assistant professor of biochemistry and biophysics at the University of California San Francisco. Exai Bio’s platform measures cell-free RNA profiles, analyzing them using AI and machine-learning algorithms, with a focus on orphan non-coding RNA (oncRNA). Section 32 and Casdin Capital led the round, with participation from Two Sigma Ventures.

FDA issued draft guidance covering the use of real-world data and real-world evidence to support regulatory decisions, and the theme throughout is transparency in data collection. The guidance, which builds on a separate draft guidance issued this year covering RWE in label expansions, discusses interventional and non-interventional studies using RWE to support IND submissions. It suggests sponsors should engage FDA early in the trial design, take several steps to prove unbiased data sources including finalizing protocols before reviewing outcomes data, and provide clear documentation around source data, protocols and algorithms. It also states that sponsors must be able to supply patient-level data from the analyses...