POMONA, Calif., July 31, 2017 /PRNewswire/ -- Immunalysis
Corporation, a division of Alere Inc. (NYSE: ALR), today announced
that its SEFRIA™ Fentanyl Urine Enzyme Immunoassay has been granted
510(k) clearance by the U.S. Food and Drug Administration (FDA) for
the qualitative detection of fentanyl in urine. The SEFRIA™
Fentanyl Urine Enzyme Immunoassay is the first ever 510(k) cleared
fentanyl enzyme immunoassay and is the first analyte utilizing
Immunalysis' proprietary SEFRIA™ technology.
Previously, fentanyl immunoassay tests were only available for
forensic testing. With the clearance of the SEFRIA™ Fentanyl Urine
Enzyme Immunoassay, fentanyl drug screening is now available for
CLIA (Clinical Laboratory Improvement Amendments) certified
reference laboratories, hospitals, physician offices and other
healthcare settings that perform moderate complexity 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, 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."
The illegal use of fentanyl is a large part of the U.S. opioid
abuse epidemic. According to the Centers for Disease Control and
Prevention (CDC), death rates from synthetic opioids such as
fentanyl increased by 72.2 percent from 2014 to 2015, due in part
to its low cost and high potency, which can be up to 50 times
greater than heroin and 100 times greater than morphine. Drug
overdoses associated with fentanyl are often linked to
unintentional ingestion when fentanyl is laced in street-sold
heroin or cocaine, which significantly amplifies its
potency.[1]
About the SEFRIA™ Fentanyl Urine Enzyme
Immunoassay
The SEFRIA™ Fentanyl Urine Enzyme Immunoassay
detects the presence of fentanyl in urine with a cutoff of 1 ng/mL.
In clinical performance studies, testing with the SEFRIA™ Fentanyl
Urine Enzyme Immunoassay compared favorably to liquid
chromatography-mass spectrometry (LC-MS) analysis in both
sensitivity (identification of positive results) and specificity
(identification of negative results).
About Immunalysis
Immunalysis Corporation, an Alere
group company, is committed to identifying and meeting the demands
of the toxicology marketplace. Since 1976, Immunalysis has
developed a range of toxicology testing solutions for use in
laboratory test facilities, including ELISA kits for forensic
laboratories, drug assays, applications for new matrices and new
immunoassay formats. For more information on Immunalysis, please
visit https://immunalysis.com/.
[1] Centers for Disease Control and Prevention (CDC).
Synthetic opioids data.
https://www.cdc.gov/drugoverdose/data/fentanyl.html; accessed
June 19, 2017.
SEFRIA is a trademark of Advance Immunoassays Inc.
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SOURCE Alere Inc.