Omicron Technologies’ AI-powered LIS, next‑generation PCR machines, and related software are provided strictly for Research Use Only (RUO) and are not intended for diagnostic procedures. These systems and any outputs they generate—including curve interpretations, confidence scores, result calls, or predictive analytics—have not been reviewed or approved by the FDA or any other regulatory authority for clinical use, patient management, or disease-related decision‑making. Use of these products for clinical, diagnostic, or therapeutic purposes is prohibited and may violate the FD&C Act, CLIA regulations, and other applicable laws.

We are committed to protecting data privacy and operate our cloud-based infrastructure in accordance with HIPAA and the HITECH Act, including encryption, access controls, audit logging, BAAs for covered entities, and regular third‑party security assessments. Only de‑identified or consented research data is used to improve AI models.

Although offered as RUO, our products are developed under rigorous quality and engineering standards, including ISO 13485‑aligned processes, internal validation, traceable documentation, change control, and continuous monitoring of performance and cybersecurity. When used in certified research environments, we maintain compliance with relevant CLIA, CAP, and state requirements.

Laboratories should consult IRBs, legal counsel, and regulatory experts before incorporating RUO systems into research workflows that may influence human subject studies or future clinical validation. Omicron Technologies makes no warranties beyond research suitability, and users are responsible for ensuring lawful and appropriate use. For regulatory or compliance inquiries, contact compliance@omicron-technologies.ai. Last updated: January 2026.