Press Release

QuidelOrtho Adds Fentanyl Test to Its Vitros® Systems as a MicroTip® Partnership Assay

Apr 10, 2024

Helping hospital and emergency room customers respond to the critical demand for enhanced opioid testing

SAN DIEGO, CA —  April 10, 2024 — QuidelOrtho Corporation (Nasdaq: QDEL) has added the ARK™ Fentanyl II Assay to its U.S. Vitros® XT 7600 and 5600 Integrated Systems as well as its Vitros® 4600 Chemistry System menu of assays as a MicroTip® Partnership Assay (“MPA”). This Fentanyl assay will help hospital and emergency room customers respond to the critical demand for enhanced opioid testing, allowing on-site fentanyl testing in less than 10 minutes to aid in immediate clinical decisions.

According to the Centers for Disease Control and Prevention (“CDC”), the number of fatalities resulting from fentanyl overdoses has tripled from 2016 to 2021, with an ongoing upward trend.1 The CDC highlights California, Florida, New York, Pennsylvania and Ohio as states with the highest mortality rates attributed to fentanyl.1 Consequently, several states have responded by implementing regulations requiring fentanyl testing to be included as a required component of drugs-of-abuse test panels.

“This assay transforms laboratory efficiency by integrating fentanyl testing with existing protocols to eliminate the need for external screening tests, and consolidates a lab’s drugs-of-abuse panel into a singular, streamlined system, reducing intervention time and ultimately helping to save lives,” said Lily Li, senior director of medical and clinical affairs at QuidelOrtho. “Our relentless commitment to diagnostics lies in empowering our customers with impactful assays, particularly those capable of delivering rapid drugs-of-abuse detection amidst the escalating opioid crisis.”

Ninety percent of fentanyl is excreted as norfentanyl, which is a synthetic opioid and is not detected on standard drug screening.1 The ARK™ Fentanyl II Assay provides preliminary analytical test results by detecting this major metabolite, reducing the risk of false negatives. As part of QuidelOrtho’s Vitros systems’ menu of assays, the test offers clinical fentanyl testing for hospitals and emergency departments, providing an effective approach to preliminary urine drug testing. 

Drug test results obtained in emergency departments play a crucial role in addressing unique hospital challenges. When patients test positive for opioids on a standard drug test, they’re usually directed to drug treatment programs. However, these standard tests fail to identify synthetic opioids, such as fentanyl.1 Without specifically testing for fentanyl, instances of fentanyl exposure might be disregarded, potentially leading to missed opportunities for life-saving interventions like administering naloxone, an opioid overdose reversal medication.

“Substance use is always changing, and medicine must change to address the problems our patients face,” said Dr. Zachary Dezman, ED physician in Baltimore and Assistant Professor with the University of Maryland School of Medicine, in collaboration with the Cesar Center for Substance Abuse, Addiction and Health Research.2 “We cannot treat a problem if we don’t detect it.”

  1. Center for Disease Control and Prevention. Opioid overdose. Accessed March 28, 2024.
  2. CESAR Center for Substance Abuse, Addiction and Health Research. UMD-led system shows success in helping hospitals understand fentanyl use in their communities. Accessed March 29, 2024.


About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day. 

Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. So that patients, clinicians and health officials can spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.

Building upon its many years of groundbreaking innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and around the globe to forge a new diagnostic frontier. One where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.

QuidelOrtho is advancing diagnostics to power a healthier future.

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