Fentanyl drug screening receives FDA clearance

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SEFRIA Fentanyl Urine Enzyme Immunoassay has received 501(k) clearance from the U.S. Food and Drug Administration for its qualitative detection of fentanyl in urine, Immunalysis Corporation announced last week.

It is the first fentanyl enzyme immunoassay to receive FDA clearance.

The drug is an opioid often used for pain management. It has been linked as a cause of abuse or addiction for long-term care residents.

Now fentanyl drug screening will be available for CLIA certified reference labs, hospitals, physician offices and other healthcare settings. Previously, fentanyl immunoassay tests could be performed only for forensic testing.

“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 of sales and marketing at Immunalysis Corporation.

Immunalysis is an Alere group company based in Pomona, CA.