The U.S. Food and Drug Administration (FDA) has granted SOLVD Health PMA supplement approval for their semi-automated INFINITI High Throughput System (HTS), according to an announcement. The approval is for the system to be used with AvertD.
The goal of this action is to address the opioid crisis, arming patients and clinicians with information that can lead to personalized care. HTS allows for more daily test processing, analyzing 20X more samples than the previously FDA-approved INFINITI PLUS Analyzer. AvertD is “the first FDA-approved genetic test for assessing elevated risk for developing opioid use disorder (OUD).”
