Labcorp Launches FDA-Cleared Fentanyl Test Delivering Results in 10 Minutes

Labcorp (NYSE: LH) launched the Labcorp Fentanyl Urine Visual Test, the first FDA-cleared rapid fentanyl urine test of its kind manufactured in the United States.

Rhea-AI Summary

Labcorp (NYSE: LH) launched the Labcorp Fentanyl Urine Visual Test, the first FDA-cleared rapid fentanyl urine test of its kind manufactured in the United States. The test delivers results in 10 minutes, detects norfentanyl with up to a 48-hour window, and is for CLIA-certified professional use.

Results are intended as preliminary screening and should be confirmed by laboratory methods. The test is available through Labcorp Point of Care (formerly MEDTOX Diagnostics), with product branding transitioning during 2026.

Positive

• FDA clearance for a rapid fentanyl urine test
• Results available in 10 minutes
• Detects norfentanyl with up to 48-hour detection window
• Available through Labcorp Point of Care nationwide

Negative

• Intended only for preliminary screening; confirmation required by lab methods
• Authorized for use in CLIA-certified professional settings only

Argus Apr 15 session

-0.80% close to close Open Argus

Details

News Market Reaction – LH

In the Apr 15 session, LH declined 0.80%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights Labcorp’s launch of an FDA-cleared rapid fentanyl urine test that deliv...

Analysis

This announcement highlights Labcorp’s launch of an FDA-cleared rapid fentanyl urine test that delivers results in 10 minutes and detects norfentanyl for up to 48 hours. It addresses rising fentanyl exposure in employment and treatment settings, building on a recent stream of collaborations and platform rollouts. Investors may track adoption in emergency and hospital settings and how such point-of-care innovations contribute to Labcorp’s broader diagnostics growth and test launch cadence.

Key Figures

Test turnaround time: 10 minutes Pre-employment fentanyl positives: 4% OUD patient fentanyl positives: 10% +5 more

Test turnaround time

10 minutes

Labcorp Fentanyl Urine Visual Test results delivery

Pre-employment fentanyl positives

4%

Share of pre-employment screenings testing positive for fentanyl (2024–2025)

OUD patient fentanyl positives

10%

Patients receiving opioid use disorder treatment testing positive for fentanyl

Detection window

Up to 48 hours

Norfentanyl presence in urine after initial fentanyl exposure

2025 revenue

$14.0 billion

Reported in DEF 14A proxy for 2025 vs prior year

2024 revenue

$13.0 billion

Prior-year revenue for comparison in DEF 14A

2025 diluted EPS

$10.46

2025 diluted EPS vs $8.84 prior year in proxy filing

2025 free cash flow

$1.2 billion

Free cash flow for 2025 vs $1.1 billion prior year

Historical Context

5 past events · Latest: Apr 13

5 events

1. Apr 13

   Pediatric diagnostics deal

   24h Move

   +1.3%

   Strategic collaboration with CHOP to accelerate advanced pediatric diagnostics.

2. Apr 09

   Dividend declaration

   24h Move

   -0.5%

   Quarterly cash dividend of $0.72 per share announced for shareholders.

3. Mar 31

   Earnings date set

   24h Move

   +2.2%

   Announcement of schedule to release and discuss Q1 2026 financial results.

4. Mar 18

   Oncology collaboration

   24h Move

   -1.8%

   Expanded Illumina partnership to broaden access to precision oncology testing.

5. Feb 23

   Digital pathology rollout

   24h Move

   +0.9%

   Nationwide deployment of PathAI’s FDA-cleared digital pathology platform.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fentanyl, u.s. food and drug administration (fda), norfentanyl, metabolite, +4 more

8 terms

fentanyl medical

"Fentanyl exposure remains a concern across acute care and clinical settings."

Fentanyl is a very powerful synthetic opioid used medically to treat severe pain and, in illicit form, can be deadly at much smaller doses than other painkillers. Investors pay attention because its medical use, strict regulation, growing illegal market and related legal or public‑health actions can affect drugmakers, hospitals, emergency services and broader liability or demand for treatments—similar to how a single safety issue can reshape an entire industry.

u.s. food and drug administration (fda) regulatory

"the first U.S. Food and Drug Administration (FDA)-cleared rapid fentanyl test of its kind"

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

norfentanyl medical

"The test assesses fentanyl exposure by detecting norfentanyl, the primary fentanyl metabolite"

A breakdown product formed when the body processes the opioid fentanyl; think of it as a chemical “footprint” that shows fentanyl was present. It matters to investors because its presence in drug tests, clinical trials, or public-health reports can signal safety, regulatory, legal, or liability issues for companies making or handling opioids, and can affect market access, reputations, and potential remediation costs.

metabolite medical

"by detecting norfentanyl, the primary fentanyl metabolite, which can remain present in urine"

A metabolite is a chemical produced when the body or a drug is broken down or used by cells — think of it as the crumbs left after digesting a meal. For investors, metabolites matter because they can be harmless, active (helping or changing a drug’s effect), or harmful, and their behavior drives safety tests, regulatory decisions, patent scope and a drug’s commercial prospects.

clinical laboratory improvement amendments (clia) regulatory

"use by qualified professionals in Clinical Laboratory Improvement Amendments (CLIA)-certified settings."

Clinical Laboratory Improvement Amendments (CLIA) are U.S. federal rules that set minimum quality and safety standards for medical laboratories that test human samples, covering test accuracy, staff qualifications, equipment, recordkeeping and routine inspections. For investors, CLIA acts like a regulatory "health inspection" for labs: certification is often required to legally run and sell clinical tests, so it directly affects a lab’s ability to generate revenue, enter markets and avoid regulatory risk.

clia-certified regulatory

"The test is FDA-cleared for use by qualified professionals in Clinical Laboratory Improvement Amendments (CLIA)-certified settings."

CLIA-certified means a laboratory has passed U.S. federal standards for performing tests on human samples, showing its results are accurate, reliable and timely. For investors this matters because certification is often required to sell clinical test services, bill insurers, win hospital or physician partnerships and avoid regulatory penalties — much like a restaurant passing a health inspection or a car getting a safety sticker before it can be sold.

opioid use disorder medical

"nearly 10% of patients receiving opioid use disorder treatment tested positive."

Opioid use disorder is a medical condition where a person repeatedly seeks and uses opioid drugs despite harmful physical, social or mental effects, often involving strong cravings and withdrawal symptoms when stopping. It matters to investors because its prevalence, availability of effective treatments, regulatory responses, and legal or insurance costs can shift demand, revenue and risk across drug makers, treatment providers and insurers—like a widespread problem that reshapes an entire market.

screening tools technical

"highlights the importance of reliable screening tools in emergency care"

Screening tools are methods or software that quickly sort and evaluate a large set of items—such as stocks, clinical candidates, or regulatory filings—against a chosen list of criteria to highlight those worth closer attention. For investors, they matter because they turn overwhelming information into a manageable shortlist of opportunities or risks, much like using a search filter to find only the most relevant results in a large catalog.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• First FDA-cleared rapid fentanyl test of its kind made in the United States designed to help emergency department and hospital teams act quickly when every second counts
• Fentanyl Urine Visual Test is available through Labcorp Point of Care, previously known as MEDTOX Diagnostics

BURLINGTON, N.C., April 15, 2026 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the launch of the Labcorp Fentanyl Urine Visual Test, the first U.S. Food and Drug Administration (FDA)-cleared rapid fentanyl test of its kind manufactured in the United States. The test delivers results in just 10 minutes, giving healthcare providers fast, actionable answers when treating suspected fentanyl exposure in emergency departments, hospitals and clinics.

Fentanyl exposure remains a concern across acute care and clinical settings. Labcorp data show that between 2024 and 2025, approximately 4% of pre-employment screenings tested positive for fentanyl, and nearly 10% of patients receiving opioid use disorder treatment tested positive. Recent guidance from the Association for Diagnostics and Laboratory Medicine (ADLM) also highlights the importance of reliable screening tools in emergency care, particularly as synthetic opioids like fentanyl become more prevalent.

"When clinicians suspect fentanyl exposure, they need quick, dependable answers to inform care," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. "The Labcorp Fentanyl Urine Visual Test delivers results in minutes, helping teams respond quickly and confidently in emergency departments, hospitals and clinics—ultimately supporting better patient outcomes."

Features of the Labcorp Fentanyl Urine Visual Test
The test assesses fentanyl exposure by detecting norfentanyl, the primary fentanyl metabolite, which can remain present in urine up to 48 hours after initial exposure. This provides a longer detection window than fentanyl itself, which may clear within hours. The test is FDA-cleared for use by qualified professionals in Clinical Laboratory Improvement Amendments (CLIA)-certified settings. Results are intended for preliminary rapid screening purposes and should be confirmed using appropriate laboratory methods, per the standard practice for rapid testing.

Introducing Labcorp Point of Care
The Labcorp Fentanyl Urine Visual Test is available through Labcorp Point of Care, previously known as MEDTOX Diagnostics. Throughout 2026, product names, packaging and resources will transition from MEDTOX Diagnostics to Labcorp Point of Care.

For more information on the Labcorp Fentanyl Urine Visual Test, visit pointofcare.labcorp.com/fentanyl-test.

About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 71,000 employees serve clients in approximately 100 countries, provided support for more than 85% of the new drugs and therapeutic products approved by the FDA in 2025, and perform more than 750 million tests annually for patients around the world. Learn more at www.labcorp.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-launches-fda-cleared-fentanyl-test-delivering-results-in-10-minutes-302742562.html

SOURCE Labcorp

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is the Labcorp (LH) fentanyl urine test and how fast are results?

The Labcorp Fentanyl Urine Visual Test is an FDA-cleared rapid screen delivering results in 10 minutes. According to the company, it provides quick, preliminary answers for suspected fentanyl exposure in emergency departments and clinical settings to guide immediate care.

How does the Labcorp (LH) test detect fentanyl exposure and detection window?

The test detects norfentanyl, the primary fentanyl metabolite, offering up to a 48-hour detection window. According to the company, measuring norfentanyl extends detection beyond fentanyl itself, which may clear from urine within hours.

Is the Labcorp (LH) fentanyl test FDA-cleared and who can use it?

Yes. The Labcorp Fentanyl Urine Visual Test is FDA-cleared and authorized for use by qualified professionals in CLIA-certified settings. According to the company, it is intended for clinical professionals performing rapid screening, not for home use.

Will Labcorp (LH) test results need laboratory confirmation?

Yes. Results are intended as preliminary rapid screening and should be confirmed with appropriate laboratory methods. According to the company, confirmation follows standard practice for rapid tests to ensure diagnostic and legal accuracy.

How does the Labcorp (LH) launch address fentanyl prevalence in screenings?

The test aims to support rapid detection amid rising fentanyl prevalence; Labcorp data show about 4% positive in pre-employment screens and nearly 10% among patients in opioid use disorder treatment. According to the company, this underscores screening needs in acute care.

Where can hospitals and clinics obtain the Labcorp (LH) fentanyl test?

Hospitals and clinics can obtain the test through Labcorp Point of Care, previously MEDTOX Diagnostics, with branding transitioning through 2026. According to the company, ordering and product information are available via the Labcorp Point of Care website.