Therapy Areas: Devices
AutoGenomics awarded US FDA breakthrough device designation for INFINITI Panel for identification of opioid dependency
5 June 2018 -

Diagnostic company AutoGenomics Inc reported on Monday the receipt of the US Food and Drug Administration's (FDA) breakthrough device designation for the INFINIT Neural Response Panel for the identification of patients who may be at risk for opioid dependency.

Opioid drugs reportedly play an important role in the clinical management of pain despite a broad spectrum of side-effects that induce a sense of euphoria often leading to addiction. The surge in prescription and illicit opioid abuse is likely the main driver of this trend.

In conjunction, the company has notified the US FDA of its intent to pursue premarket clearance through the US FDA De Novo process.

According to the company, the INFINITI Neural Response Panel is a qualitative in vitro diagnostic test for the identification of patients who may be at risk for opioid dependency. The panel is designed to identify 16 genetic mutations involved in the brain reward pathways that are associated with increased risk of opioid use disorder and is intended for use by physicians as an aid for safe and effective pain management.

Under the Breakthrough Device Programme, the US FDA will provide its support to advance the INFINITI Neural Response Panel. The commitment from the US FDA for priority and expedited review and senior management involvement will enable a reduced regulatory timeline, concluded the company.

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