Research-use materials and clinical-use limitations.
ONETest™ reagents, software, and related materials are supplied by Fusion Genomics for research use only unless otherwise stated in a specific agreement, document, or applicable laboratory implementation. They are not intended by Fusion Genomics for diagnostic or therapeutic use.
Any clinical use must be independently validated, performed, interpreted, and reported by an appropriately accredited laboratory under that laboratory’s applicable regulatory, accreditation, and quality framework.
References on this website to clinical validation, hospital deployment, laboratory workflows, or implementation activities should not be interpreted as universal regulatory clearance, authorization, or approval for diagnostic use in any jurisdiction.