FDA-Approved Fentanyl Drug Screening Assay to Help Identify Opioid Abuse

For the first time, the US Food and Drug Administration (FDA) has approved a urine-based immunoassay to detect fentanyl in living patients. The SEFRIA Fentanyl Urine Enzyme Immunoassay, developed by toxicology company Immunalysis, was approved by the authority under the medical devices regulatory pathway.

While immunoassays for fentanyl detection already exist, they have largely been used in forensic testing to determine whether cause of death was due to a drug overdose. In contrast, Immunalysis’ test can be used by professionals in laboratories, hospitals and other healthcare environments to qualitatively detect fentanyl in the urine of patients.

“The availability of an FDA-cleared fentanyl immunoassay enables more reference and hospital laboratories to conduct precise qualitative screening, which is a key strategy in stemming the alarming increase in misuse and abuse of fentanyl,” said Kathy Miller, Vice President, Sales and Marketing, Immunalysis Corporation. “The SEFRIA fentanyl urine drug screening test rounds out our offering of technologically advanced assays for detecting prescription and illegal drugs of abuse by providing clinicians and toxicologists with a relevant menu of FDA-cleared opiate and opioid tests.”

Illegal use of opioids in the US has been on the rise in recent years, with fentanyl being more potent and less expensive when compared to morphine and heroin. Between 2014 and 2015, deaths attributed to synthetic opioid abuse have increased by 72 percent, according the Centers for Disease Control and Prevention.

The SEFRIA Fentanyl Urine Enzyme Immunoassay is sensitive enough to detect fentanyl levels as low as 1 ng/mL. Immunalysis is a division of Alere, a company that provides point-of-care diagnostics for the healthcare industry.