Home 5 Clinical Diagnostic Insider 5 The Diagnostics Pipeline: FDA Approves First Ever Fentanyl Test Strips for OTC Use

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

by | Nov 24, 2023 | Clinical Diagnostic Insider, FDA-dtet

Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.

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.

FDA regulation of fentanyl detection tests

The FDA has cleared in vitro diagnostic (IVD) laboratory-based tests capable of detecting fentanyl in human specimens since 1989.3 But all of these tests are instrument-based. In December 2022, the agency cleared the first fentanyl test for use at the point of care, the Superbio Fentanyl Urine Detection Kit from Shenzhen Superbio Technology.4 The agency has also approved OTC use of non-urine tests that drug users can perform to monitor their own medications by crushing the pills into a powder. But it had never before given clearance for a urine fentanyl detection strip read visually for OTC use by healthcare professionals, law enforcement, and other forensic purposes in a non-CLIA setting.

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

TestManufacturerClearance Date
Alltest Fentanyl Rapid TestHangzhou AllTest Biotech Co.October 26, 2023
Superbio Fentanyl Urine Detection KitShenzhen Superbio TechnologyDecember 13, 2022
LZI Fentanyl II Enzyme ImmunoassayLin-Zhi International, Inc.August 7, 2020
ARK Fentanyl II AssayARK Diagnostics, Inc.February 26, 2020
Psychemedics Microplate EIA for Fentanyl in HairPsychemedics Corp.April 18, 2019
LZI Fentanyl ImmunoassayLin-Zhi International, Inc.December 3, 2018
ARK Fentanyl AssayARK Diagnostics, Inc.June 6, 2018
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corp.June 14, 2017
COAT-A-COUNT(TM) FENTANYL (TKFN1)Diagnostic Products Corp.September 28, 1989
Source: Based on information from the FDA

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

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

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

    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)

Manufacturer(s)Product
Cordance MedicalBreakthrough Device designation for NeuroAccess™ device for transiently opening blood-brain barrier to elevate concentration of cell-free DNA analytes in blood circulation
PaigeBreakthrough Device designation for Paige Lymph Node artificial intelligence (AI) software for detecting breast cancer metastases in lymph node tissue
Aria Diagnostics + SigTuple Technologies510(k) clearance for SigTuple AI100 with ShonitTM instrument to automate digitization of peripheral blood smear samples
AbbottClearance for Abbott RealTime IDH1 Assay as companion diagnostic for Servier Pharmaceuticals’ Tibsovo (ivosidenib) in patients with relapsed or refractory myelodysplastic syndrome
MAWD LaboratoriesEUA for MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR test
FloBioBreakthrough Device Designation for rapid bleeding test for determining clotting status at point of care
Foundation Medicine (Roche subsidiary)Clearance for FoundationOne®CDx and FoundationOne®Liquid CDx as companion diagnostics for Pfizer’s BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation
Foundation Medicine (Roche subsidiary)Clearance for FoundationOne®CDx as companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib) for treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or are following prior systemic treatment or who have no satisfactory alternative treatment options
Sanguina510(k) clearance for AnemoCheck Home self-test for those with anemia to monitor hemoglobin levels
EntroGenPremarket approval for CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix® (panitumumab), a targeted colorectal cancer therapy
ProciseDxDe Novo clearance for therapeutic drug monitoring  tests for adalimumab (Humira® and biosimilar Amgevita®) and infliximab (Remicade® and biosimilars Inflectra® and Renflexis®)
Tangen BiosciencesEUA for TangenDx SARS-CoV-2 Molecular Test
SD BiosensorEUA for STANDARD Q COVID-19 Ag Test 2.0 lateral flow immunoassay to detect nucleocapsid protein antigen from SARS-CoV-2
InvitaeDe Novo clearance for Common Hereditary Cancers Panel, DNA sequencing test identifying variants in 47 genes associated with elevated risk of various cancers

New CE marks and global certifications

Notable European CE certifications announced during the period: 

New Approvals in Europe

Manufacturer(s)Product(s)
AliveDx (formerly Quotient)MosaiQ® Centromere Protein B microarray immunoassay to detect autoantibodies to centromere protein B for diagnosing connective tissue diseases
AliveDx (formerly Quotient)MosaiQ® AiPlex CTD (connective tissue diseases) assay to detect autoantibodies to native, double-stranded DNA, Sm, U1RNP, SS-A (Ro-60), Trim-21 (Ro-52), SS-B, SCL-70, Jo-1, Sm/RNP, centromere protein B, and ribosomal P for diagnosing CTDs
AliveDx (formerly Quotient)Multiconstituent MosaiQ® AiPlex CTD Quality Controls
bioMérieuxVIDAS® TBI (GFAP, UCH-L1) blood test to help assess mild traumatic brain injury based on combination of two brain biomarkers: GFAP and UCH-L1
ELITechGroupPCR-based class B infectious disease assays, including gastrointestinal tests and a test for the bacteria Bordetella
Shanghai Kehua Bio-EngineeringDiagnostic Kit for HIV (1/2) Antibody (Colloidal Gold) V2
MasimoLiDCO® board-in-cable module to connect to multi-patient monitoring platforms for advanced hemodynamic monitoring
ZeptoMetrixIVDR certification for majority of firm’s CE-marked ZeptoMetrix NATtrol™ quality control products

Other international clearances announced during the period:

Manufacturer(s)Country(ies)Product(s)
Burning Rock BiotechChinaOverC™ Multi-Cancer Detection Blood Test
 Geneseeq Technology ChinaNon-Small Cell Lung Cancer Tumor Mutational Burden Test Kit (reversible terminator sequencing method) to measure efficacy of immune checkpoint inhibitor therapy
GencurixAustraliaDroplex POLE Mutation Test targeting endometrial cancer mutations

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