Alere Launches Alere iCup® Rx Drug Screen for Detecting Commonly Misused and Abused Prescription Drugs

WALTHAM, Mass., July 19, 2017 /PRNewswire/ -- Alere Inc. (NYSE: ALR), a global leader in rapid diagnostics, today announced the availability of its point-of-care Alere iCup^® Rx Drug Screen, a rapid urine test that detects five of the most commonly misused and abused prescription drugs. The test enables physicians and addiction specialists to screen patients for benzodiazepines, buprenorphine, methadone, opiates and oxycodone in a clinically actionable timeframe – facilitating early detection of abuse and ensuring patient compliance with legitimately prescribed therapies.

The Alere iCup Rx was developed in response to the rapid and alarming rise in abuse of prescription therapies (such as Vicodin^® and OxyContin^®) that treat pain and addiction. Unlike other drug tests that combine illicit and prescription drug detection, the Alere iCup Rx is the first rapid urine test that tests and validates five of the most clinically relevant prescription drugs at one time – streamlining testing and monitoring of patients in medical and addiction management settings.

"Frequent in-office monitoring is an essential strategy to address opioid abuse, a threat which has become a menacing epidemic," said Robert L. DuPont, M.D., Clinical Professor of Psychiatry at the Georgetown University School of Medicine and first Director of the National Institute on Drug Abuse (NIDA). "An easy-to-use test that provides actionable results during a patient visit is a valuable first-line tool to detect potential opioid abuse and, when it occurs, to get these patients the specific addiction treatment they need."

Point-of-Care Monitoring: A Key Strategy in Addressing Prescription Drug Abuse
Abuse of prescription analgesics and other drugs has grown so significantly that the Centers for Disease Control and Prevention (CDC) has officially declared it an epidemic.^[1] As of 2012, there were almost 17,000 fatal overdoses of prescription opioid analgesics a year in the United States,^[2] and opioid-related deaths now exceed deaths involving heroin and cocaine combined.^[3] Over time, prescription opioid abuse may lead to the use of heroin, which can be easier to obtain. In many cases, misuse and abuse begins when patients are legitimately prescribed opioids for severe acute or chronic pain. It is essential, therefore, that physicians and addiction treatment professionals conduct regular in-office drug testing to assess outcomes, identify relapses, and adjust therapies in real time.

"Arming clinicians with a rapid test that screens only the most relevant prescription drugs not only helps determine whether patients are misusing a drug that was not prescribed, but also helps ensure adherence to legitimately prescribed therapies," said David Green, Ph.D., RP and Laboratory Director, Alere. "The Alere iCup Rx addresses an important unmet market need for real-time testing of these drugs that are essential to effective pain and addiction management but frequently abused."

About the Alere iCup Rx
The Alere iCup Rx is a 510(k)-cleared and CLIA-waived, lateral flow chromatographic immunoassay for the qualitative detection of benzodiazepines, buprenorphine, methadone, opiates and oxycodone in urine. The Alere iCup Rx features a self-contained collection cup plus test device, and provides auto-activated results in 5 minutes with no tipping of the cup. The Alere iCup Rx also features a specimen validity test (SVT) to help monitor specimen tampering and adulteration, with a lower opiate cutoff level (300 ng/mL) than most other urine drug assays. The drug assays provide only preliminary analytical test results, which must be confirmed with more specifi­c chemical methods, such as gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS). Alere laboratories provide laboratory confirmation services with a high standard of compliance, superior analytical methods and state-of-the technology.

About Alere
Alere believes that when diagnosing and monitoring health conditions, Knowing now matters.™ Alere delivers on this vision by providing reliable and actionable information through rapid diagnostic tests, enhancing clinical and economic health outcomes globally. Headquartered in Waltham, Mass., Alere focuses on rapid diagnostics for infectious disease, cardiometabolic disease and toxicology. For more information on Alere, please visit www.alere.com.

^[1] Centers for Disease Control and Prevention (CDC). Glossary. The CDC defines "epidemic" as "[t]he occurrence of more cases of disease than expected in a given area or among a specific group of people over a particular period of time." Available at https://www.cdc.gov/vaccines/terms/glossary.html.
^[2] CDC, National Center for Health Statistics. CDC WONDER Online Database, 2012. Beletsky LB, Rich JD, Walley AY. Prevention of fatal opioid overdose. JAMA. 2013;308(180): 1863–1864
^[3] CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers --- United States, 1999—2008. MMWR. 2011; 60(43):1487-1492. Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm.

SOURCE Alere Inc.