Gaining 510(k) clearance from the Food and Drug Administration, two new drug screening tests offer practitioner rapid, in-office results for the most commonly abused opioid-derived drugs.
By Kathleen Doheny
Interviews with Scott Taille and Michael R. Clark, MD, MPH, MBA
Physicians who are treating patients for pain now have two new urine screening options available for in-office use to detect for opioid misuse and abuse, and one of these tests will screen for the presence of fentanyl.1,2
The iCUP Rx Drug Screen, launched by Alere (Waltham, Massachusetts), delivers drug levels for five of the most commonly abused opioid-derived drugs. The second new test, the Sefria Drug Screening Kit, is the first and only available in-office product to enable physicians to monitor for the presence of fentanyl; the Sefria kit is available from Immunalysis Corporation, a division of Alere.
Both urine drug-screening tests received 510(k) clearance from the Food and Drug Administration (FDA),1 and will be covered for reimbursement by health insurers, said Scott Taille, vice president of global channel markets for Alere’s toxicology division.
Expanding the Ability of Practitioners to Screen for Fentanyl
In recent years, the mixing of illicitly produced fentanyl, a synthetic opioid, with heroin has become increasingly common and sought after on the street. It has played a key role in leading to the epidemic of opioid-related overdose deaths, as reported in the Centers for Disease Control and Prevention (CDC) trends report on deaths from 2006-2015.3 In the last five years of the report, heroin overdose deaths quadrupled with sharp increases in the supply of heroin and IMF as likely contributors.2 During this time, fentanyl’s popularity has been attributed to its low cost, high potency, and easy access.
The fentanyl test ”is the first and only test [for fentanyl] that has gained FDA clearance,” said Mr. Taille. Previously, the test was available only “for forensic use, used primarily in the criminal justice system,” he told Practical Pain Management, but we have made it possible to extend its use to the clinical setting. The cost to doctors will be about $8 each.
The SEFRIA test, which will be sold to doctors for $1.50 per kit, has the ability to detect the presence of fentanyl in urine with a cutoff of 1 ng/mL. Clinical performance studies show it compares favorably to liquid chromatography-mass spectrometry (LC-MS) analysis, both for sensitivity and specificity.2
We expect the primary users will most likely be hospital laboratories and physician offices that have onsite labs, according to Mr. Taille, as such, we anticipate that larger group practices, not solo practitioners, will be early adopters of these new tests.
How Does This Rx Urine Drug Screen Work?
Alere’s iCup Rx Drug Screen will deliver rapid results from the urine analysis that is capable of detecting five of the most commonly misused and abused pain medications—benzodiazepines, buprenorphine, methadone, opiates, and oxycodone. The goal is to provide pain practitioners will a tool to enable early detection of abuse. The aim is to establish a mechanism to improve patient compliance with legitimately prescribed therapies, according to the company
“What is unique about the iCup Rx is that it was the first point-of-care test that zeroed in on the most frequently prescribed medications in order to give clinicians an on-the-spot answer to [possible abuse] and filtered out the noise,” Mr. Taille told Practical Pain Management.
Similar urine analysis screens, he said, may test for 13 or 14 drugs in all. Our screening test focuses solely on pain-related drugs that pain practitioners are most concerned about most in terms of what needs to be monitored.2 The iCup test comprises five unique assays built into a single urine collection cup, said Taille, with results available in no more than five minutes. This will permit the prescriber to evaluate the status of the drug levels in the patient immediately, facilitating the appropriate dialogue with regard to renewing or denying a refill of the prescription.
“Each test strip is calculated to a particular cut off,” Mr. Taille said, for opioids, it is 300 ng/mL, which is lower than most other urine drug assays, according to the company.
The assays for this test provide only preliminary analytical test results. They must be confirmed with more robust methods such as gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS). Alere’s lab offers such confirmation services.
A Clinician’s Response to Rapid Opioid Urine Testing
The new tests will offer wider options for physicians caring for pain patients, said Michael R. Clark, MD, MPH, MBA, director of the Chronic Pain Treatment Program and an associate professor of psychiatry and behavioral sciences at Johns Hopkins University.
“Every pain doctor who is prescribing chronic opioid therapy will benefit from the ability to screen for drug abuse,” Dr. Clark told Practical Pain Management.
In particular, the fentanyl test could be potentially useful to screen for while the patient is present to assist in making a clinically informed decision, he said, about whether or not to prescribe oxycodone, for instance. If fentanyl is detected in the urine, there is a high likelihood that the patient has been using heroin, since much of it is mixed with fentanyl, according to Dr. Clark.
As reported by the CDC,4 early 90% of unintentional overdose deaths examined in 24 Ohio counties in January and February 2017 involved fentanyl, fentanyl analogs, or both with heroin identified in only 6% of cases.
So this new test ”may be another viable option but it depends on what the current point-of-care testing is able to detect. It can give the practitioner greater specificity or indicate that the patient is using illicit substances since most fentanyl use is obtained on the street, not prescribed,” said Dr. Clark.
Whether the other new test for the prescription drug screening is useful to a specific physician, Dr. Clark said, may depend partly on the patient population, and what prescription drugs they are likely to be taking.
Scott Taille is an Alere employee; Dr. Clark has no financial conflicts of interest.
- US Food and Drug Administration. 510(k) Premarket notification. Medical Devices. Available at: accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161216. Accessed on September 8 2017.
- Alere launches Alere iCup Rx drug screen for detecting commonly misused and abused prescription drugs. PRNewsire. July 19, 2017. Available at: prnewswire.com/news-releases/alere-launches-alere-icup-rx-drug-screen-for-detecting-commonly-misused-and-abused-prescription-drugs-300490440.html
- O’Donnell JK, Gladden RM, Seth P. Trends in Deaths Involving Heroin and Synthetic Opioids Excluding Methadone, and Law Enforcement Drug Product Reports, by Census Region—United States, 2006-2015. MMWR, 1, 2017. Available at: www.cdc.gov/mmwr/volumes/66/wr/mm6634a2.htm?s_cid=mm6634a2_w. Accessed on September 8, 2017.
- Daniulaityte, R. et al. Overdose Deaths Related to Fentanyl and Its Analogs—Ohio, January-February 2017. Sept. 1, 2017. Available at: www.cdc.gov/mmwr/volumes/66/wr/mm6634a3.htm. Accessed September 8, 2017.