AUTOGENOMICS, INC

Autogenomics, Inc. specializes in in vitro diagnostic (IVD) devices primarily focused on opioid use disorder (OUD) genotyping. Their portfolio includes nucleic acid-based testing kits for genetic analysis, oral/upper respiratory specimen collection kits, and high-throughput microarray analysers. These devices are designed to support clinical workflows for detecting genetic markers related to opioid metabolism and addiction risk, as well as automated sample processing and analysis systems.

Autogenomics, Inc. is headquartered in the United States. Its devices are regulated under the US Food and Drug Administration (FDA) framework. The company’s products fall under Class II and Class III classifications, depending on their intended use and risk level. These classifications determine the regulatory pathway for authorization, with some devices listed under the FDA’s 510(k) premarket notification process, others under the Premarket Approval Application (PMA), and all assigned Unique Device Identifiers (UDIs) for tracking.

Autogenomics, Inc.’s devices are included in the FDA’s key regulatory registries, specifically the 510(k) Premarket Notification Database, the Premarket Approval Application (PMA) registry, and the Unique Device Identifier (UDI) database. These registries ensure transparency and compliance with US regulatory requirements for in vitro diagnostics, including genotyping kits, specimen collection tools, and high-throughput analysers used in clinical settings.

The FDA classifies Autogenomics, Inc.’s devices into either Class II or Class III categories based on their risk level and intended use. Class II devices generally pose moderate risk and require performance standards or special controls, while Class III devices are higher risk and typically require a Premarket Approval Application (PMA) due to insufficient data from less stringent pathways. The classification ensures appropriate oversight for devices like OUD genotyping kits and microarray analysers, balancing safety and innovation.

Autogenomics, Inc. offers a range of IVD devices tailored for OUD genotyping, including nucleic acid technique (NAT) kits for genetic testing, buccal sample collection kits for oral specimen collection, and automated high-throughput systems like the INFINITI® analysers. These systems integrate processing, amplification, and microarray analysis to detect genetic variations linked to opioid metabolism, aiding in personalized treatment strategies for patients. The company also provides consumables like reagent modules and amplification mixes to support these workflows.