Central labs and rapid testers both find a place in the drugs of abuse testing m

By Nicholas Borgert

Drug testing in the United States has continued to increase, with IVD manufacturers responding to demands to test for new substances and offer more rapid results. From pro athletes to pilots to production workers, in the ER, on the job and at schools, random and routine drugs of abuse testing (DAT) has become a part of the landscape of American life. Both large central labs and small rapid test providers are gaining ground in the DAT marketplace.

Despite objections from varied sources about aspects of school and workplace drug testing, these market segments have spurred demand for new products. Overall, employment drug testing among large firms is up 300 percent since 1987, according to a survey by the American Management Association. There are financial incentives, too. A number of states offer discounts on workers’ compensation insurance to companies whose drug-free workplace program includes drug testing. When the economy tightens, employees become more willing to accept drug testing as a condition of their hiring and/or employment. Court decisions, likewise, have enabled broader testing for drugs as a condition of participation in school extracurricular activities. To date, however, fewer than 5 percent of school districts are involved in drug testing.

Emergency Departments in hospitals have also seen a demand for more rapid tests, including those able to detect newer drugs of choice.

Biosite
Biosite’s flagship product is the Triage Drugs of Abuse Panel. In just 10 years, Biosite’s expertise in rapid drug testing has earned it a market share that the company estimates at nearly 35 percent of the clinical drugs of abuse testing market. Its Triage Drugs of Abuse test has been adopted by nearly half of U.S. acute care hospitals, said Scott Thomas, senior product manager for drugs of abuse testing. Thomas believes the DAT trend is toward rapid testing with a shorter turnaround time, and faster diagnosis. Biosite offers two different platforms: the Triage qualitative platform for rapid screening of multiple analytes using a hand-held device, and a Triage Panel that tests for up to eight abused drugs simultaneously with results in 10 minutes with visual yes/no display.

This year, Biosite introduced the Triage TOX Drug Screen for toxicology screening of urine for up to eight classes of commonly abused drugs in 15 minutes. Based on the Biosite Triage MeterPlus, Triage TOX is a rapid point-of-care drug test that enables hospitals to store patient results and provides data management capabilities between laboratory information systems (LIS) and hospital information systems (HIS) from remote locations.

American Bio Medica Corporation
American Bio Medica’s flagship product is the Rapid Drug Screen, and the company is projecting growth of up to 50 percent for the year. Founder and Executive Vice President Stan Cipkowski said his company used Biosite as its model, believing that rapid testing for drugs of abuse in hospitals would grow faster and made more economic sense than traditional lab testing.

“We focused on workplace drugs of abuse testing, with a plan to grow into criminal justice markets and then clinical markets,” Cipkowski said. “We’re there now.” This year, American Bio Medica will be profitable for the first time. The criminal justice segment will account for about half the company’s business ($6 million) and the company soon takes its Rapid Drug Screen to the hospital market with assistance from a major clinical partner.

Cipkowski sees lots of speculation about saliva testing and a variety of new and recycled technologies. “There’s a place for saliva testing,” he said. “Urine is the gold standard, however. I don’t believe that saliva will amount to any more than 20 percent of the entire market. Hair testing is going in the other direction.”

His company has benefited from the Supreme Court’s June 2002 decision to uphold school drug testing for students participating in extracurricular activities. “We’ve made an investment in marketing our product to schools over the past couple of years and now will put even more emphasis on this area,” Cipkowski said.

OralStat 6 is a one-step saliva test with results in 10 to 15 minutes. RapidTec 5 is a single stick with up to 5 tests on one test strip. American Bio Medica has also just released a cup-based product called StarTox Cup.

Cipkowski said testing diversity is key. “Saliva, multiple on one stick, in a cup, whatever the market wants for delivery method, but it has to be fast and accurate,” he said.

Roche Diagnostics
Roche Diagnostics has offered DAT products for 30 years, but has moved more robustly into the market with its point of care products, the OnTrak TesTcup and TesTstik. While growth projections for the desktop market are flat, they are healthy for the rapid DAT segment.

According to Jim Linehan, Roche DAT product manager, central labs currently perform about 95 percent of DAT. Linehan puts the Roche market share for the non-clinical (criminal justice and workplace testing) segment at over 50 percent, with revenues from that sector in the $30 million range.

Small- and medium-sized hospitals have been able to use point of care drug testing meters without having to purchase a general chemistry analyzer. Also, Linehan said, the portable meters have given larger hospitals the ability to streamline their workflow and decrease turnarond time by taking DAT reagents off their benchtops. But until recently, this type of testing involved five labor-intensive steps, all of which needed to be performed within 15 to 20 minutes. New lower-cost, single-step alternatives have begun surfacing in the last year. Roche’s own OnTrak TesTcard 9 panel is a single-step test with results in three minutes.

According to Linehan, TesTcard 9 starts with the same antibodies, the Abuscreen OnLine reagents, used on Roche’s Hitachi and Integra analyzers. These antibodies are combined with Roche’s patented Latex Particle Inhibition technology, which Roche hopes will position TesTcard 9 as a new standard in rapid testing.

Sales of Abuscreen OnLine reagents (for Roche chemistry platforms) to reference laboratories such as LabCorp and Medtox, represent about 11 percent of the automated clinical market.

Linehan said Roche is responding to customer requests for DAT that are faster and easier to use. TesTcard 9, with its nine panels, separates Methamphetamines from Amphetamines.

“AMP/METH assays … have been hampered by the high rate of Methamphetamines false positives,” he said. “By separating METH from AMP, we give the ER physician greater confidence in the results for amphetamines,” he said. High crossreactivity helps detect newer drugs of abuse, specifically MDMA.

Dade Behring’s flagship product is the Syva RapidTest System. Kelli Ryzewski, Syva Director of Marketing, said the Syva line continues to expand, adding more multi-drug panels that increase the number of drugs it can screen. Syva has been testing for drugs of abuse since 1967. Dade Behring acquired the Syva brand seven years ago.

Because of high interest in point of care drug testing for most ED STAT requests, the hospital segment has been growing significantly for her company, Ryzewski said. The single-use hand-held urine RapidTest provides results in five minutes. Highlights include the release of the Syva Emit reagents in the Dimension Flex and the Syva partnership with Olympus for higher volume toxicology labs.

Syva multi-drug panels detect up to eight drug classes, including Amphetamines/Methamphetamines, barbituates, benzodiazepines, cocaine, methadone, PCP, opiates, THC and Tricyclic antidepressants.

Ryzewski says customers continue to demand assays that are more sensitive and able to detect more of the newer drugs of use and abuse, including designer drugs, GHB and ketamine. Also specimen validity testing has become an important part of drug testing, Ryzewski said. “Outside the clinical market, drug testing is increasing dramatically, especially in drug courts,” she said.

Cost efficiency, demand for menu expansion and the proposed guidelines of the Substance Abuse and Mental Health Services Administration (SAMHSA), Ryzewski said, are driving the market right now.

Olympus America Inc.
The Olympus flagship products are the AU5200 and AU5000 instruments and DAT reagents. Susan Watanabe, Ph.D, senior product manager for Olympus Diagnostic Systems Group, said POC testing has expanded over the last 10 years to address STAT situations. Centralized drug testing is typically done in non-acute cases such as insurance testing, forensic cases or long-term care. In contrast to POC, she said, centralized lab results are produced in a more cost-effective, controlled and documented environment.

DAT business has grown sharply for Olympus in large part because of its partnership with leading reagents supplier Dade Behring. While the Olympus AU5200 and AU5000 have long been popular instruments for high volume toxicology sites, new business the last three years has come in moderate- to high-volume labs using new Olympus bar-coded DAT reagents and the company’s instruments for low to very high throughputs.

“An ongoing concern is the validity of the result, especially with the use of adulterants,” Dr. Watanabe said. “An advantage of centralized testing is the ability to perform multiple tests for drugs and adulterants on the same specimen in a controlled environment that can guard against specimen tampering and provide appropriate documentation.”

Accuracy and low cost, Dr. Watanabe believes, are the two forces driving centralized DAT testing. Olympus/Dade Behring efforts have launched several new products that reduce errors and labor. Dade Behring has released new liquid and ready-to-use DAT reagents to replace older formulations that required operator time for solubilization.

“Olympus’ new AU400, AU640, AU2700 and AU5400 instruments provide advanced reagent and data management and new ease-of-use,” Dr. Watanabe said. “As a net result, labs benefit through a reduction in operating costs with additional safeguards for accuracy.”

Faster TAT
The industry in general has responded to demands for faster turn around times for drugs of abuse tests, whether the testing is done on clinical chemistry analyzers in the central lab, or at the point of care. At Beckman Coulter, for example, drugs of abuse panels can be run on the Synchron series of analyzers.

The Synchron CX9 clinical chemistry system can deliver results for a seven-test drugs of abuse profile in 30 minutes. Prior to the CX9, the same test profile took an hour and involved a number of manual steps. Consolidating testing for general chemistry, therapeutic drug monitoring and DAT, all from a single sample, may offer advantages depending on the testing needs of the laboratory.

Beckman’s new Synchron LXi 725 Clinical System helps decrease preanalytical process steps and improve turnaround time, as well as increasing safety, which can be particularly important in drugs of abuse testing. The system features automation and closed-tube aliquotting (CTA) and closed-tube sampling (CTS) technology. Closed-tube sampling (CTS) technology reduces sample-processing time. The test menu for the LXi includes approximately 150 assays, including basic critical care, drugs of abuse, therapeutic drug monitoring, cancer, cardiac, fertility, thyroid tests and more. The system accommodates 65 analytes onboard at once, including 24 immunoassay and 41 chemistry.

The Synchron LX20 Pro Clinical System also uses closed-tube sampling (CTS) technology, and an NPIA detection system which operates at 940 nm. Currently, the Synchron LX20 Pro test menu includes more than 100 reagents comprised of general chemistries, critical care chemistries, proteins, serologies and esoteric chemistries as well as therapeutic drug monitoring (TDM) and drugs-of-abuse testing (DAT) reagents. The Synchron LX20 Pro processes 1,440 tests per hour. Other features include continuous auto-loading, closed-tube obstruction detection/correction, automatic critical sample rerun and default panel testing so that users can program specific test parameters.

Abbott Laboratories offers drugs of abuse tests on its Axym Plus and Aeroset platforms. Ten new drugs of abuse assays are now available for the Aeroset clinical chemistry analyzer. These assays include: amphetamines, cannabinoids, barbituates, benzodiazepines, cocaine, methadone, PCP, propoxyphene, opiates and ethanol.

Abbott’s drugs of abuse product line includes FPIA assays on the Axsym platform, and the new liquid ready-to-use Optimized Multiplied Enzyme Chemistries (OMEC) assays for the Aeroset analyzer. These products feature excellent methods correlation. Assays run on the Aeroset platform feature optical throughput of 1,600 photometric tests per hour. In addition, Abbott has introduced the Signify ER drug screen test.

Trends in Drugs of Abuse in the ED
Identification of drugs of abuse is a critical factor in emergency care. In the year 2000, there were 601,563 drug-related ED episodes, with 1,099,306 total drug mentions, for an average of 1.8 drugs per episode. Table 1 shows the top 50 most frequently mentioned drugs whose abuse was a factor in a visit to the emergency room.

The drugs of abuse that are making current news headlines are relatively small in absolute numbers, but have seen dramatic percentage growth in visits to the emergency room. As Table 2 shows, “designer” or “club” drugs had extremely low numbers in 1994, but enormous percentage increases through 2000. There were also emergency room increases in the narcotic analgesics receiving so much attention in the news: hydrocodone and oxycodone, as well as methadone and morphine. As further evidence of the growing problems with hydrocodone and oxycodone, there are approximately 8 ED mentions of hydrocodone and 4 of oxycodone for every 1 mention of morphine. Although hydrocodone appears to be the most greatly abused drug in this category, it is oxycodone, or OxyContin, that is the larger media story.

Overall, 80 percent of ED drug mentions come from only 7 categories: alcohol-in-combination, cocaine, heroin, marijuana, antidepressants, benzodiazepines and analgesics. Cocaine is the most frequently mentioned illicit substance, present in 29 percent of ED episodes. Almost a quarter of these cocaine episodes are attributable to crack, though crack use has remained stable over the past several years. Cocaine type substances are the main problem drugs in the Americas, responsible for the majority of treatment demand and most drug-related crime and violence. By contrast, opiates are a larger problem in the rest of the world.

Unlike the stable levels of cocaine usage, heroin has been on the rise. Heroin mentions increased 50 percent over the 7-year period from 1994 to 2000, with a 15 percent increase from 1999 to 2000 alone. Large increases in that single year period, the most recent in the DAWN data, are also seen for MDMA or Ecstacy at 58%, PCP at 48%, Amphetamines at 37%, and Methamphetamines at 29%. The use of the muscle relaxant carisoprodol (sold as Soma or Rela) also increased.

The rates of abuse of other particularly worrisome drugs have remained stable, including GHB, LSD, inhalants and ketamine.

Drugs to watch
Soon after a therapeutic drug receives FDA clearance and emerges in the marketplace, the potential for its abuse begins. Part of the function of the DAWN is to identify drugs that move from obscurity to emergency in a short time period. Several new drugs had no mentions in 1994, but over 1,000 mentions by the year 2000. There were three antidepressants: citalopram, mirtazapine and nafazodone. Two antipsychotics also saw a marked rise: olanzapine and quetiapine. And, two central nervous system agents appear on the list: celecoxib and tramadol. Several other antidepressants also saw very large increases between 1994 and 2000, particularly bupropion, venlafaxine, risperidone and zolpidem.

A place in the testing market
The ever-changing range of compounds to be identified, together with increasing demand to identify major drugs of abuse more rapidly, assures a time of product development in this segment of the IVD industry.

Nicholas Borgert is a freelance writer in Charlotte, N.C.