The Diagnostics Pipeline: FDA Approves First Ever Fentanyl Test Strips for OTC Use

There were more than 105,000 drug overdose deaths in the United States in 2022, according to the US Centers for Disease Control and Prevention (CDC). Continuing recent patterns, use of fentanyl, a synthetic opioid drug that is roughly 50 times more potent than heroin, caused an increasing number of those deaths.¹ In many cases, the victims did not realize that the drugs they were taking—whether legally or illegally—contained fentanyl. While fentanyl test strips can minimize this risk, they are not widely available. On October 27, the US FDA took a step to combat opioid drug overdoses by announcing its first ever clearance for an over-the-counter (OTC) test strip to detect the presence of fentanyl in urine.²

The Alltest fentanyl urine test

Developed by Hangzhou AllTest Biotech Co., Ltd., the Alltest Fentanyl Rapid Test (called the Alltest Fentanyl Urine Test Cassette in the FDA release) is a kit consisting of a test cassette containing a fentanyl test strip.

Users place three drops of fresh urine onto the cassette and within five minutes get a visual readout containing colored lines indicating whether fentanyl is present. Test results are preliminary only and must be confirmed by laboratory testing. The kit includes a pre-addressed box that allows users to ship the sample to the manufacturer’s laboratory for confirmatory testing. Other limitations apply, the FDA notes:²

• • the test does not distinguish between drugs of abuse and certain medications,

• • the test may produce a false result if it is contaminated with bleach or another substance, and

• consumption of certain foods or food supplements may lead to a false positive.

Significance of clearance for OTC fentanyl urine test

There’s an emerging market for lab testing products capable of detecting trace amounts of fentanyl in an individual’s system for clinical and forensic purposes, notes veteran lab market consultant Lawrence Worden of IVD Logix. This market includes:

• • hospitals and reference labs that use fentanyl testing for acute treatment decision-making;

• • testing for purposes of law enforcement;

• • testing performed by drug addiction counsellors at non-CLIA settings, including prior to admission to rehab clinics and centers; and

• employer drug testing, where urine specimens are typically collected away from the lab and shipped to the facility for testing.

The FDA had previously approved the Alltest fentanyl assay for prescription use. The newly issued 510(k) clearance for OTC use expands the test’s accessibility and convenience.

Being able to perform the test without a prescription should be especially useful for drug addiction counsellors, Worden says. “Most of the current OTC urine tests on the market detect natural opioids and synthetic opioids other than fentanyl.” About 93 percent of fentanyl tests done in these settings are urine screens, he adds.

In the longer term, FDA OTC approval for a urine test could be a significant step toward adding fentanyl to the standard menu of immunoassay analyzers for the performance of opioid screening tests. Worden points out that current immunoassay options are based on the federal Substance Abuse and Mental Health Center Administration (SAMHSA) 12-drug urine screening test for drugs of abuse, which does not include fentanyl. Worden adds that this omission is significant and out of touch with the spike in fentanyl drug overdose deaths of the past five years.

“While legislation has been proposed to add fentanyl to the SAMHSA panel, FDA approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could go a long way in expanding accessibility,” he says.

G2 Intelligence also reached out to Mayo Clinic, one of the nation’s leading providers of fentanyl testing, for comments on the FDA clearance, but did not receive a response before the deadline for this article.  

Fentanyl Detection Kits with 510(k) Clearance

The fact that the FDA issued 510(k) clearance for the new Alltest fentanyl strip within 16 days after receiving the submission underlines the agency’s urgency in dealing with the opioid overdose crisis. “Opioid abuse, misuse, and addiction is one of the most profound public health crises facing the US today,” noted FDA Center for Devices and Radiological Health director Jeff Shuren, MD, JD, in the press release announcing the clearance. “This test is an example of the FDA’s continued commitment to authorize tools that can reduce deaths associated with overdoses.”¹

One barrier to widespread adoption of fentanyl test strips is that they are illegal in some states. Because strips are associated with illegal drug use, they are contained in laws that states began adopting in the late 1970s to ban drug paraphernalia. In 2018, Rhode Island became the first state to decriminalize fentanyl testing strips. Since then, over 30 other states and the District of Columbia have followed suit.⁵ Technically, fentanyl testing strips remain illegal in Arkansas, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Missouri, Montana, North Dakota, South Dakota, and Texas.

References:

1. 1. https://blogs.cdc.gov/nchs/2023/05/18/7365/

1. 1. https://www.fda.gov/news-events/press-announcements/fda-roundup-october-27-2023

1. 1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K891605

1. 1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220046

1. https://www.networkforphl.org/wp-content/uploads/2023/01/Legality-of-Drug-Checking-Equipment-in-the-United-States-August-2022-Update.pdf

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Here are the other key new laboratory testing and diagnostics products clearances that were announced in October 2023:

New FDA Approvals and Emergency Use Authorizations (EUAs)

New CE marks and global certifications

Notable European CE certifications announced during the period: 

New Approvals in Europe

Other international clearances announced during the period: