INDUSTRY TRENDS

Diagnostics Industry Responding to Opioid Epidemic

Prescription opioids are among the most common drugs prescribed and are the most effective treating for pain, whether it is debilitating, chronic pain or temporary pain, such as after surgery.

While effective at pain relief, opioids can cause severe complications, are highly addictive, and are frequently misused. The numbers behind the opioid epidemic are staggering. The Substance Abuse and Mental Health Services Administration says that in 2014, almost 2 million Americans abused or were dependent on prescription opioids. The U.S. Centers for Disease Control and Prevention found that 91 Americans die every day from an opioid overdose and since 1999, the number of overdose deaths involving opioids (both prescription opioids and heroin) quadrupled.

Clinicians must finely balance between working to control rising rates of opioid abuse, while adequately managing patients’ pain. Clinical laboratory tests have an important role in helping to support efforts aimed at curbing abuse and the diagnostics industry is responding to an eager market with new tests. It is estimated that there are 116 million people with chronic pain worldwide. But pain management specialists are only a fraction of the whole opioid-related testing market. Worker’s compensation programs, oncologists, rheumatologists, orthopedists, and sports medicine providers are all opioid prescribers and potential users of screening or risk assessment tests.

DTET examined a sampling of tests aimed at opioid surveillance, screening at the point-of-care, and assessing risk of addiction using genetic factors.

Testing for Surveillance
Quest Diagnostics’ (Madison, N.J.) 2017 analysis of its annual workplace drug testing shows that drug use in the American workforce, fueled by illicit drugs, reached the highest positivity rate in 12 years. The annual analysis of the Quest Diagnostics Drug Testing Index examines more than 10 million workforce drug test results across three categories of workers: federally-mandated, safety-sensitive workers; the general workforce; and the combined U.S. workforce.

The annual analysis breaks down positivity rate by drug category, including opioids. In 2016, following four years of increases, urine-testing positivity for heroin, remained steady in the general U.S. workforce and declined slightly among federally-mandated, safety-sensitive workers. Prescription opiate positivity declined in urine testing among the general U.S. workforce, indicating that state and federal efforts to more tightly control opiate prescribing may be having an impact. Continued surveillance and screening testing will be necessary to assess the impact of opioid policy on use and misuse.

Point-of-Care Testing
While workforce drug testing is important to ensuring safe, accident-free environments, point-of-care testing is important to clinicians prescribing opioids to enable early detection of misuse and ensure patient compliance with prescribed therapies.

This summer Alere (Waltham, Mass.) released two new FDA-cleared point-of care tests. The iCUP Rx Drug Screen, is a lateral flow chromatographic immunoassay that tests for five of the most commonly abused opioid-derived drugs — benzodiazepines, buprenorphine, methadone, opiates, and oxycodone. The iCup test builds the five assays into a single, self-contained urine collection cup and results are available in less than five minutes. iCup results are considered preliminary, and the company says they must be confirmed with more laboratory-based methods such as gas chromatography-mass spectrometry or liquid chromatography-tandem mass spectrometry.

"Frequent in-office monitoring is an essential strategy to address opioid abuse, a threat which has become a menacing epidemic," said Robert DuPont, M.D., director of the National Institute on Drug Abuse, in a statement on behalf of Alere. "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."

The second new test, the Sefria Drug Screening Kit, is the first in-office product capable of screening for fentanyl; a super-powerful opioid that is 50- to 100-times more potent than morphine. The company says that the test was previously available for forensic use, but this clearance enables it to be used in clinical settings.

Multi-Drug Testing
A new biochip array can simultaneously screen for 20 drugs of abuse in urine, according to a study presented by Randox Toxicology (United Kingdom) at the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo (San Diego, July 30 to Aug. 3).

Biochip array technology enables maximal output through the detection of multiple analytes from a single sample. The company’s DOA Ultra Urine biochip array is run on the Evidence Evolution analyzer, which is a fully automated, high-throughput system. Additionally, the platform offers random access with STAT capability.

The assay is based upon competitive semi-quantitative chemiluminescent technology, with signal output inversely proportional to the concentration of drug in the sample. Cutoff values and limits of detection were determined for each of the 20 analytes. The cutoff values were further validated by assessing inter-assay precision.

The company says that time to first result is 36 minutes, and that 60 samples can be loaded per hour. No sample preparation is required and toxicology tests can be run alongside other clinical tests making, making "this system a new reliable multi-analytical tool for test consolidation," the company says.

Assessing Genetics of Addiction
It is suspected that genetic factors play a role in addiction, but they are currently not widely evaluated in clinical practice. Researchers believe that identifying these genetic factors can enable improved opioid management and tailored prescribing to better prevent abuse and addiction.

Autogenomics (Carlsbad, Calif.) has a commercially available multivariant genetic panel and prediction algorithm that it says can distinguish diagnosed addicts from those with lower risk of addiction. The company made two presentations at the AACC annual meeting.

AutoGenomics researchers compared the frequency of 16 single nucleotide polymorphisms involved in the brain reward pathways in 37 patients with and 30 matched controls without opioid addiction. Results were used to design the predictive model scored one to 100. Any score over 52 represents an elevated risk of addiction.

Use of the Addiction Risk Assessment Panel and prediction score algorithm was then validated on an additional 138 patient samples—70 patients diagnosed with prescription opioid and/or heroin addiction and 68 non-affected individuals. Of the 70 addicts tested, 53 had an addiction risk score greater than 52, while 49 of the 68 healthy controls scored under 52, yielding a 76 percent sensitivity and 72 percent specificity. Both the positive and negative predictive values of this model were 74 percent.

Despite the desire for a sure-fire solution to guide opioid prescribing decisions, Autogenomics is realistic about the capabilities of a test to predict the genetic risk of addiction.

"Right now we need to make better use of tools to address opioid management. It is very clear that genetics is a very good tool, but it is not the only tool," Fareed Kureshy, the CEO of AutoGenomics tells DTET. "It depends on one’s genetic makeup to determine how the body will respond to and metabolize the drug. But, a physician is in charge and they cannot strictly use genetics to reach a conclusion. When starting opioids they can look at a panel to advise them on dosage and if a patient shows addictive tendencies. But, they have to use their judgment, too."

Caution Urged for Tests of Addiction Risk Prediction
Despite urgent need for opioid-related testing products and industry’s desire to capitalize on ripe market conditions, some experts are questioning the quality of evidence surrounding these emerging tests, particularly in the realm of risk prediction, The diagnostics industry has been cautioned to maintain its high standards in test development and validation, including the need for validation of laboratory-developed tests in large studies.

One company receiving intense scrutiny is Proove Biosciences (Irvine, Calif.). This summer the Stat News late last year and early this year that questioned the Federal Bureau of Investigations raided the company’s office in a health care fraud investigation, centered around the company’s practice of allegedly providing kickbacks to doctors for enrolling patients in its research studies.

While the investigation is focused on fraud, addiction experts have raised concerns regarding emerging tests’ abilities to predict opioid addiction risk. Joel Gelertner, M.D., from Yale University, has publicly raised concerns that both Proove’s and Autogenomics’ tests’ accuracy claims are based upon small studies. He additionally raised concerns that the genetic markers included in the panels were derived from literature searches, rather than more comprehensive genome-wide association studies.

Takeaway: The diagnostics industry is taking an active role in helping to curb the opioid epidemic. However, the industry has been cautioned to maintain its high standards in test development and validation, despite the overwhelming need for new products.

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