University of Colorado Develops Comprehensive New Drug Assay
The University of Colorado School of Medicine has developed a sweeping new toxicology panel it claims will detect the presence of drugs at a much lower levels and with significantly less labor than existing assays. If true, the test could potentially be a game-changer in the highly competitive drug testing segment, which has seen significant […]
The University of Colorado School of Medicine has developed a sweeping new toxicology panel it claims will detect the presence of drugs at a much lower levels and with significantly less labor than existing assays. If true, the test could potentially be a game-changer in the highly competitive drug testing segment, which has seen significant growth among laboratories in recent years. Several enterprises that focus specifically on drug testing have become labs with extensive regional or even a national presence. According to university officials, the test can detect more than 500 different drugs in 19 separate categories via a single urine sample undergoing mass spectrometry and molecular analysis. Secondary testing to provide accurate data, or to focus on the detection of specific drugs, is unnecessary. The test can also detect drugs such as codeine at levels of 10 nanograms per deciliter, compared to many other assays, which cut off detection at 300 nanograms per decileter. As a result, officials claim the new assay will detect five times the level of drug use than other tests on the market. In one comparison test, the assay detected twice as many positives for cocaine, and three times as many positives for codeine, compared to other screening techniques. The test was developed by the university about four years ago as a research project, with clinical sample assays beginning in late 2011. About 10,000 test assays were performed to confirm accuracy, officials said, and there have been no known false positives. Although data from Quest Diagnostics, the nation’s largest laboratory, indicate that positive drug tests have been on the decline in recent years, positives for prescription painkillers have been on the rise. Data from the Centers for Disease Control and Prevention also indicate deaths from that category of drugs have surpassed overdose deaths from illicit narcotics. And positives for multiple drugs in a single test occur up to 11 percent of the time, according to data from Ameritox. “Polypharmacy, or the use of multiple drugs at once, is the newest American epidemic; more than one in five U.S. citizens are using three or more prescription drugs, and more than one in 10 are using five or more,” said Jeffrey Galinkin, M.D., a professor of anesthesiology and pediatrics at the University of Colorado School of Medicine. “Combine that with the fact that drug overdose death rates in the U.S. have more than tripled since 1990, and it’s clear the industry is in crisis and desperately needs a more comprehensive urine drug test.” The university appears assured of the test’s success: It launched a not-for-profit company, CU Toxicology, to distribute the test, with Galinkin serving as its chief medical officer. It already has 25 employees and two dozen clients in Colorado, Pennsylvania, and Michigan, including Kaiser Permanente’s Colorado division. Testing takes place at an 8,000 square-foot lab on the School of Medicine campus in Aurora, Colo. The test retails for between $100 and $200 depending on how results are structured, according to Blair Whitaker, CU Toxicology’s director of business operations. Turnaround times are between 24 and 48 hours depending on what time of the workday a sample is received. Test data is provided electronically. Samples must be mailed in by clients; there is no courier or outreach service. Current test volume is relatively low, at about 2,000 assays per month. But Whitaker projects it will more than double, to 5,000 a month, by the end of the year.
“We believe in the area of drug abuse, and the discovery of abuse, we have a very novel technology,” Whitaker said. Takeaway: A new drug test developed by the University of Colorado could raise the bar for sensitivity of testing—as well as market competition.