AutoGenomics, Inc., announced that INFINITI Neural Response Panel has been granted designation, by the US Food and Drug Administration (FDA), as a breakthrough device.
The panel is a qualitative in vitro diagnostic test used for the identification of patients who may be at risk for opioid dependency and is intended for use by physicians as an aid for safe and effective pain management.
“We believe that this multi-variant addiction panel with its predictive algorithm represents a significant tool for health care practitioners to identify and better manage patients at risk of opioid dependency,” Fareed Kureshy, president, chief executive officer, AutoGenomics, said in a statement.
Researchers led an extensive 3-year search into scientific literature of addiction studies and additionally conducted 2 independent clinical studies which led to the selection of 16 genetic variants involved in the brain reward pathways associated with increased risk of addiction.
The variant panel and predictive algorithm were utilized for a clinical study of 70 patients diagnosed with prescription drug-induced opioid/heroin addiction and 68 normal control subjects.
Initial results concluded that the genetic panel and predictive algorithm distinguished between the 2 populations of addicted versus normal subjects, with both the positive and negative predictive values determined to be 74%.
Study results describing the predictive algorithm included in a multi-variant genetic panel were presented at the 69th AACC Annual Scientific Meeting and Clinical Expo where the poster, “Risk assessment of opioid addiction with a multi-variant genetic panel involved in the brain reward pathway” received 2017 Industry Division Poster Award.
The INFINITI Neural Response Panel is designed to identify 16 genetic mutations involved in the brain reward pathways associated with increased risk of opioid use disorder.
The FDA has been notified by AutoGenomics of its intent to pursue premarket clearance through the De Novo process.