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Labcorp Launches FDA-Cleared 10-Minute Rapid Fentanyl Urine Test

New point-of-care test detects fentanyl metabolite norfentanyl, extending detection up to 48 hours to support faster clinical decisions in acute care settings

Written byToday's Clinical Lab
| 2 min read
Fentanyl remains a leading driver of drug overdose deaths in the US, yet detection in clinical practice remains inconsistent.
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Labcorp has launched a new FDA-cleared rapid test designed to improve detection of fentanyl exposure in clinical settings where timely decision-making is critical. The Labcorp Fentanyl Urine Visual Test delivers results in 10 minutes and is intended for use in emergency departments, hospitals, and other CLIA-certified care environments. 

The test is now available through Labcorp Point of Care, the company’s rapid diagnostics portfolio previously known as MEDTOX Diagnostics.

Fentanyl remains a leading driver of drug overdose deaths in the US, yet detection in clinical practice remains inconsistent. According to Labcorp, only about 1 in 5 overdose patients are tested for fentanyl, and conventional testing approaches may fail to capture exposure due to short detection windows. The new test is designed to address these limitations by improving both speed and detection sensitivity.

Detecting exposure beyond fentanyl alone

A key feature of the test is its ability to detect norfentanyl, the primary metabolite of fentanyl. This extends the detection window up to approximately 48 hours after exposure, compared to fentanyl itself, which may clear from the body within hours. The company notes that this broader detection window is intended to improve clinical visibility in suspected exposure cases.

The test is FDA-cleared for use by qualified professionals in CLIA-certified settings. Results are intended for preliminary rapid screening and are meant to be confirmed using standard laboratory methods, consistent with established practices for point-of-care testing.

“As 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.”

Designed for rapid clinical decision-making

The test provides results in 10 minutes, allowing healthcare providers to act during the same patient encounter. Labcorp emphasized that this rapid turnaround is intended to support immediate clinical decisions in acute care environments, where time-sensitive intervention may be required.

In addition to clinical use, Labcorp highlighted broader public health relevance, noting that fentanyl exposure is increasingly seen in both intentional and unintentional contexts due to contamination of other substances. 

The company cited internal data showing that between 2024 and 2025, approximately 4 percent of pre-employment screenings tested positive for fentanyl, while nearly 10 percent of patients in opioid use disorder treatment tested positive.

Read More: Can Pharmacogenetic Testing Optimize Pain Management?

Expanding point-of-care diagnostics

The Fentanyl Urine Visual Test is the first FDA-cleared rapid fentanyl urine test of its kind manufactured in the US, according to Labcorp. It also marks the launch of the product under the Labcorp Point of Care brand, which will transition from the former MEDTOX Diagnostics identity throughout 2026.

Labcorp positions the test as part of a broader effort to expand rapid diagnostic tools that support faster identification of drug exposure and improved clinical response in high-risk settings.

Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.

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