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FDA Grants Breakthrough Designation for AutoGenomics' Infiniti Neural Response Panel

NEW YORK (GenomeWeb) – AutoGenomics said today that its Infiniti Neural Response Panel — a genomic test that gauges risk for opioid dependency — has been granted designation as a breakthrough device by the US Food and Drug Administration.

Intended for use by physicians as an aid in prescribing pain medication, the Infiniti panel uses an algorithm to detect and weigh 16 genetic mutations involved in brain reward pathways, which in turn affect risk of opioid use disorder.

Under the FDA's breakthrough device program — which addresses medical tests or other devices that demonstrate potential to address unmet medical needs — the agency will provide its support to accelerate the advancement of AutoGenomics' test through the regulatory review process.

The company describes the Infiniti test, which it hopes to bring to market through the FDA's de novo premarket pathway, as borne of extensive review of the scientific literature. Investigators first gave a presentation on the approach at the American Association for Clinical Chemistry's annual meeting in San Diego last year.

"We believe that this multi-variant addiction panel with its predictive algorithm represents a significant tool for healthcare practitioners to identify and better manage patients at risk of opioid dependency," AutoGenomics President and CEO Fareed Kureshy said in a statement.