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Premier Biotech Wins FDA Clearance for Drugs of Abuse Assays

NEW YORK (360Dx) — Premier Biotech said today it has received 510(k) clearance from the US Food and Drug Administration for two additional assays for use on its OralTox oral fluid-based drugs of abuse device.

According to the Minneapolis-based company, it has received clearance for assays for oxycodone and methadone. OralTox now has 510(k) clearance for in vitro diagnostic use — including at point-of-care sites — for amphetamine, cocaine, marijuana, methadone, methamphetamine, opiates, oxycodone, and phencyclidine.

Premier said that OralTox can scale to detect up to 12 drugs simultaneously, and that it intends to develop additional assays. It added that OralTox devices can be sent to its laboratory for confirmation of presumptive positive results.

"Now with the clearance of oxycodone and methadone for OralTox, we are directly responding to the opioid crisis in the United States by enabling corporations and clinical groups alike to promptly screen and identify these illicit substances in a non-invasive manner," Premier CEO Todd Bailey said in a statement.