Immunalysis’ Sefria earns FDA approval for opioid screening

Until now, immunoassay tests for fentanyl were restricted to forensic use.
Until now, immunoassay tests for fentanyl were restricted to forensic use. | File photo

Formulated to detect the presence of the potent opioid fentany in urine, California-based Immunalysis Corp.’s branded immunoassay Sefria — the first of its kind — recently achieved 510(k) clearance from the U.S. Food and Drug Administration.

Until now, immunoassay tests for fentanyl were restricted to forensic use. Now, the screening test can be used by approved laboratories, hospitals, practitioners’ offices and similar health care facilities with the capability to perform the test.

"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," Kathy Miller, Immunalysis Corp.’s vice president for Sales and Marketing, said.

Fentanyl, an opioid pain medication with a rapid onset and short duration of action, plays a big role in the nation’s opioid abuse landscape. Deaths caused by synthetic opioids increased by 72.2 percent in the course of just one year, from 2014 to 2015, according to the U.S. Centers for Disease Control and Prevention.

"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," Miller said.

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