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

Rhea-AI Summary

QuidelOrtho introduces the ARK™ Fentanyl II Assay to its Vitros® XT and 5600 Integrated Systems to aid hospitals in responding to the increasing demand for enhanced opioid testing. The assay provides rapid fentanyl testing in under 10 minutes, crucial for immediate clinical decisions amidst the rising opioid crisis.

Insights

Medical Research Analyst

The introduction of the ARK™ Fentanyl II Assay by QuidelOrtho represents a significant advancement in the field of emergency medicine and toxicology. The ability to quickly and accurately test for fentanyl, a potent synthetic opioid, is a critical development given the alarming increase in overdose fatalities linked to this drug. The assay's integration into established systems like the Vitros® XT 7600 and 5600 Integrated Systems, as well as the Vitros® 4600 Chemistry System, streamlines the testing process for medical facilities.

From a medical research perspective, the assay's detection of norfentanyl, the primary metabolite of fentanyl, addresses a previously unmet need for specificity in opioid testing. Standard drug panels often miss synthetic opioids, leading to underdiagnosis and underreporting of fentanyl-related cases. The enhanced capability could improve clinical outcomes by enabling timely interventions, such as the administration of naloxone for overdose reversal.

However, it is essential to consider the potential for false positives or negatives inherent in any rapid testing method. The assay's accuracy and reliability will be important factors in its adoption and impact on patient care. Additionally, the economic implications for hospitals must be weighed, as the cost of implementing such advanced testing capabilities could be significant.

Healthcare Economist

The opioid crisis has placed a substantial economic burden on the healthcare system. The addition of the ARK™ Fentanyl II Assay to QuidelOrtho's product offerings could have a notable impact on healthcare economics by potentially reducing the long-term costs associated with opioid overdoses. By enabling immediate on-site testing, hospitals may see a decrease in the need for extended patient stays and additional diagnostic procedures, which are often required when initial tests fail to identify substances like fentanyl.

Furthermore, the rapid identification of fentanyl in patients can lead to more targeted and efficient use of resources, such as the appropriate allocation of naloxone and other treatment modalities. This could translate into cost savings for both healthcare providers and insurers. However, the initial investment in these assays and the necessary training for medical staff will need to be factored into the overall cost-benefit analysis.

It is also worth considering the potential for this technology to be leveraged in the development of public health strategies aimed at combating the opioid epidemic. By providing data on fentanyl use patterns, healthcare providers and policymakers can better allocate resources and design interventions to address this public health challenge.

Market Research Analyst

From a market perspective, QuidelOrtho's launch of the ARK™ Fentanyl II Assay could be seen as a strategic move to capitalize on the growing demand for more comprehensive drugs-of-abuse testing. The opioid epidemic has created a pressing need for accurate and rapid testing solutions in hospitals and emergency departments across the United States. As regulations evolve to mandate more extensive testing, QuidelOrtho is positioning itself as a key player in this niche market.

The company's stock market performance could be influenced by the adoption rate of this new assay, as well as the broader public health response to the opioid crisis. Investors will be interested in monitoring sales figures and market penetration, as well as any partnerships or collaborations that may arise from this product launch. It is also essential to observe how QuidelOrtho's competitors respond to this innovation and whether they introduce similar assays, which could affect market dynamics.

Overall, the introduction of the ARK™ Fentanyl II Assay may be seen as a value-added proposition, enhancing QuidelOrtho's existing product line and potentially driving growth in a market with an urgent need for such diagnostic tools.

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

SAN DIEGO--(BUSINESS WIRE)-- 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.

QuidelOrtho Vitros® XT 7600 Integrated System (Photo: Business Wire)

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, a collaborating ED physician in Baltimore and Assistant Professor with the University of Maryland School of Medicine, after working 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. https://www.cdc.gov/drugoverdose/deaths/opioid-overdose.html
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. https://cesar.umd.edu/feature/umd-led-system-shows-success-helping-hospitals-understand-fentanyl-use-their-communities

Resources:

• Global MPA Website – MicroTip Partnership Assays (MPAs) | QuidelOrtho

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.

For more information, please visit www.quidelortho.com.

Source: QuidelOrtho Corporation

View source version on businesswire.com: https://www.businesswire.com/news/home/20240410125315/en/

Investor Contact:

Juliet Cunningham

Vice President, Investor Relations

IR@QuidelOrtho.com

Media Contact:

D. Nikki Wheeler

Senior Director, Corporate Communications

media@QuidelOrtho.com

Source: QuidelOrtho Corporation

FAQ

How does QuidelOrtho help hospitals and emergency rooms with enhanced opioid testing?

QuidelOrtho introduces the ARK™ Fentanyl II Assay to its Vitros® XT and 5600 Integrated Systems to aid hospitals in responding to the increasing demand for enhanced opioid testing.

What is the significance of the ARK™ Fentanyl II Assay in fentanyl testing?

The ARK™ Fentanyl II Assay provides rapid fentanyl testing in under 10 minutes, crucial for immediate clinical decisions amidst the rising opioid crisis.

Why is fentanyl testing important in hospital settings?

Fentanyl testing is crucial in hospital settings to detect synthetic opioids like fentanyl, which may be missed by standard drug tests, potentially leading to missed opportunities for life-saving interventions.

How does the ARK™ Fentanyl II Assay contribute to reducing false negatives in drug testing?

The ARK™ Fentanyl II Assay detects norfentanyl, a major fentanyl metabolite, reducing the risk of false negatives in drug testing.

What role does rapid drug testing play in emergency departments?

Rapid drug testing in emergency departments is crucial for addressing unique hospital challenges and providing effective preliminary urine drug testing for patients.