Belay Diagnostics

Executive Summary

Belay Diagnostics is a San Diego-based biotechnology company developing cerebrospinal fluid (CSF) liquid biopsy tests for central nervous system (CNS) malignancies. Founded in 2019, the company aims to provide a minimally invasive, genomically informative alternative to tissue biopsies for diagnosing and managing primary and metastatic brain and spinal cord tumors. Belay's proprietary tests leverage advanced molecular diagnostics to enable better-informed clinical decision-making, potentially improving patient outcomes by reducing the risks associated with surgical biopsies and enabling earlier detection of molecular markers. As a private company in the rapidly growing liquid biopsy space, Belay Diagnostics is poised to address a significant unmet need in neuro-oncology, where access to tumor tissue is often limited and standard diagnostic methods have high morbidity. With no disclosed funding rounds or valuation, the company appears to be in early commercial or clinical validation stages, focusing on building evidence to support adoption in clinical practice. The company's key catalysts include upcoming clinical data readouts from studies validating test accuracy against tissue biopsy gold standards, which could establish clinical utility and drive adoption. Additionally, discussions with the FDA for breakthrough device designation or submission of a de novo classification request could accelerate regulatory clearance. Finally, partnerships with major cancer centers for clinical trials or laboratory services could expand access and credibility. Belay Diagnostics operates in a competitive landscape but differentiates through its exclusive focus on CNS malignancies and CSF-based analysis. Success will depend on generating robust clinical evidence, achieving regulatory milestones, and securing commercial partnerships.

Upcoming Catalysts (preview)

• Q3 2026Clinical validation study results demonstrating >95% concordance with tissue biopsy for glioma diagnosis70% success
• Q4 2026FDA breakthrough device designation or submission of de novo request for CSF liquid biopsy in primary CNS tumors60% success
• H2 2026Partnership with a leading neuro-oncology center for multi-site clinical trial or laboratory services agreement65% success