CEO SUMMARY: The urine drug testing industry is challenged every day to detect the large number of patients trying to cheat on their drug tests. GenoTox Laboratories of Austin, Texas, developed a DNA-authentication method for urine samples that allows the lab to detect when patients have used a substitute for urine when undergoing medication- and sobriety-monitoring. Called ToxProtect, the test authenticates samples and detects urine sample substitutions.
EVERY LABORATORY WANTS TO DIFFERENTIATE its lab testing services. The goal is to add value to the physicians and patients it serves while giving it a competitive advantage over other labs. A lab company in Austin, Texas, has developed a diagnostic service that it hopes will help it achieve both goals.
GenoTox Laboratories is a toxicology lab company that provides testing for medication monitoring in pain management and sobriety programs. It saw an opportunity to give its client physicians and other licensed providers a way to ensure that the urine specimen collected from a patient did, indeed, come from that patient.
Authenticity of Specimens
“Urine testing is the gold standard for monitoring for drug abuse and treatment compliance,” stated Shawn Lunney, COO of GenoTox. “So, it becomes a significant problem when the authenticity of the specimen is in question. It can threaten the integrity of the therapeutic treatment plan and compromise the trust crucial in the physician-patient relationship.
“Addiction is a disease of the brain and not a moral failing,” said anesthesiologist and board-certified pain specialist Matthew McCarty, MD, Founder and Chair of GenoTox. “By the time a patient is addicted, he or she will do anything to access the drug, including cheating on urine tests.”
Every clinical laboratory performing drugs of abuse testing knows that patients commonly attempt to fool these tests. Synthetic urine and similar products intended to corrupt the testing are a billion-dollar business. Using warmed substitute urine often is touted online as a fool-proof way to cheat a drug test.
GenoTox saw the opportunity to improve the integrity of urine drug testing. It believed many physicians would take advantage of a service that would scientifically confirm—with 100% accuracy—that the urine specimen submitted to the lab was from the patient being tested.
To give physicians confidence that the lab results come from the patient, GenoTox developed an assay, called ToxProtect, that uses DNA-authentication of urine samples. Company executives thought the test could revolutionize medication and sobriety monitoring. A patent is pending for this test.
“The test represents the first innovation in the science of urine testing in over a decade,” Lunney told THE DARK REPORT. “It’s disruptive technology aimed at significantly improving the value by overcoming the shortcomings of current validity testing in urine drug testing.”
Next-Generation Drug Test
GenoTox calls ToxProtect a next-generation urine drug test (UDT) that authenticates samples, reveals mislabeling errors, and detects urine sample substitutions. The test involves adding a one-time cheek swab to the urine collection process.
When a physician has questions about a sample’s authenticity or if there is a history of unexplained results in the presence of normal validity measures, a physician will order ToxProtect. GenoTox has used ToxProtect on more than 10,000 samples.
Based on its experience working with ToxProtect and clinical specimens, GenoTox learned that, each time ToxProtect reported a negative match (where the patient’s urine specimen and the patient’s DNA sample did not match), in 98% of these cases, the validity tests for the urine specimen had reported normal (that it was human urine). GenoTox concludes that these findings demonstrate how easily warmed substitute urine can fool validity testing methods.
GenoTox uses advanced technologies, such as Agilent 6460 liquid chromatography systems, for its urine testing. Its test detects more than 100 controlled substances and reveals the presence of synthetic or substitute human urine. Results are delivered via online physician portal, fax, or EMR interface, usually within 32 hours.
To develop the genetic ID with its ToxProtect assay, the lab uses genomic cross-verification to match a urine sample to its donor. The matching has been accurate in 100% of the cases.
The need for a way to positively confirm the authenticity of a urine specimen and that it does come from the patient is recognized by other health organizations. For example, in June, the American Medical Association issued a CPT code (0007U) for ToxProtect. This code will be added to CMS’ Clinical Laboratory Fee Schedule for 2018 as a proprietary laboratory assay.
In addition to CMS, other payers are interested as well. “GenoTox has been accepted as an in-network provider by Amerigroup and Blue Cross,” stated Michael Willoughby, GenoTox’ Chief Commercial Officer. “Insurers recognize that there is value in getting the earliest possible detection of illicit drug use.
“Discontinuing opioids when cheating occurs saves on future urine drug testing and other services,” he explained. “Also, recognizing relapse in addiction earlier than conventional drug testing allows doctors to start more aggressive treatment, such as medication-assisted treatment.”
Other laboratories have considered co-marketing the ToxProtect test. “We’re in active discussions across the country,” noted Willoughby. “We have 20 reps in various states and are looking at the possibility of strategic partnerships with larger labs that cover regions where we do not have reps and to partner with hospital outreach programs.”
Flagging Patients Who Cheat by Adulterating Their Samples
“WE HAVE MANY STORIES OF SUCCESS with our positive patient ID test,” stated Michael Willoughby, Chief Commercial Officer of GenoTox. “One physician using ToxProtect had 12 patients who did not match the specimens. This test enabled him to identify sample-adulterating issues that would otherwise have gone unnoticed.
“At another clinic, ToxProtect revealed 13 substitutions in the first 200 confirmations,” he added. “These physicians had the opportunity to consult with their patients who were substituting urine samples and place them on a revised treatment plan. They were able to discuss potentially life-threatening issues such as addiction and discontinue controlled substances or, by recognizing earlier relapse, recommend a higher level of addiction treatment.
“Another benefit to ToxProtect is that it doesn’t take long for a physician’s patients to learn about its ability to detect adulterated urine specimens,” he continued. “We’ve had feedback that ToxProtect becomes a deterrent against cheating, resulting in open conversations about what is truly going on with the patients in their treatment plans.
“Our client physicians tell us that ToxProtect has helped many of their patients get back on track,” explained Willoughby. “One doctor told us that a patient actually called in and admitted to submitting synthetic urine in a random test when faced with genetic matching. These are patients who previously slipped through the system without being detected.”
Willoughby also pointed out that another benefit of ToxProtect is how patients no longer have to go to a collection center to provide a urine sample. “They can do it at home and ship the specimen to the lab overnight. “This convenience factor can help patients stay on track and provide a truly randomized sample collection.”
Developed to Fill a Need
It was an actual incident in his clinic that motivated McCarty to develop a solution to counter patients who cheat on their drug tests. McCarty, board-certified in pain medicine, recounted the story of an overheard conversation between a mother and daughter in the lobby of his clinic, which caught his attention. “I heard the mother say to her daughter, ‘Make sure it’s the right temperature,’” recalled McCarty. “I knew that synthetic urine kits often include methods for warming the solution to mimic an authentic specimen. This episode motivated me to find a fail-safe way to match urine drug test specimens and donors.”
Recognizing the frustrations physicians have when prescribing pain medications because of all the “cheat on urine test” products for sale in the marketplace, McCarty asked his team at GenoTox if there was any way to match the specimen to the patient.
“It took us about two years to develop a method to accomplish this goal,” stated Lunney. “It can be difficult to isolate DNA from urine.”
Proliferation of Tox Labs
Another factor supports the need for a solution that positively confirms the authenticity of a urine specimen. It is the explosive growth in opioid prescriptions and the associated need to use drug tests to monitor patients’ compliance. That growth also brought with it a proliferation of new toxicology laboratories built around urine testing.
Many of these toxicology and pain management lab companies use questionable and even fraudulent business models and practices so as to quickly cash in on the profit boom of the confirmatory testing market.
“The toxicology world in general has built a reputation around urine drug testing that is less than credible,” McCarty told THE DARK REPORT. “At the same time, the opioid epidemic presents complex challenges for all stakeholders.
“That includes what we call the four P’s: patients, physicians, payers, and populations,” he added. “Payers are faced with questionable claims. Communities across all demographics are being affected. Patients are at risk of not getting the safety and therapeutic benefits of their treatment plan. Physicians face uncertainty regarding the authenticity of urine specimens.”
Lunney highlighted an associated industry which enables patients to cheat on their urine tests. “Today, hundreds of vendors are selling synthetic urine products designed to cheat the UDTs,” he observed. “This is now a $1 billion-dollar-year industry in the United States!
500 Fake Urine Products
“For example, Amazon.com currently features almost 500 products intended to prevent accurate UDT results and just four years ago only 120 products were offered,” observed Lunney. “Sadly, traditional validation measures—including pH, temperature, creatinine, and specific gravity—are not 100% reliable in uncovering this healthcare fraud
“Until now, there has been no solid authentication method capable of definitively matching the patient to the sample. That means that current estimates of drug diversion—12.8%—are likely low,” he continued. “It becomes very challenging for doctors to simultaneously balance legitimate patient needs against reasonable vigilance measures, including UDTs, while maintaining effective therapeutic relationships with patients.”
When asked how physicians were responding to the ToxProtect test, Willoughby was quick to respond. “Physicians tell us that ToxProtect is a valuable clinical tool in three primary areas,” he said. “First, it helps them protect a patient’s treatment plan by answering the nagging questions surrounding a particular sample’s authenticity.
Opioid Epidemic Fuels Need to Stop Drug Test Cheating
ACROSS THE NATION, OPIOID ADDICTION is now a major problem. The story of the opioid epidemic is steeped in tragedy, rooted in greed, and marked by a critical need for effective tools to address the problem.
The statistics of the opioid crisis are staggering—both in terms of the number of overdose deaths and the broader economic impact. According to the CDC’s website, between 2000 to 2015, more than 500,000 people died from drug overdoses. Overall, federal officials estimate that opioid abuse drains nearly $80 billion a year from the American economy.
In July, the President’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that the president declare the opioid-addiction crisis to be a national emergency priority.
Cheating Patients Identified
“Second, it uncovers patients who are cheating, making it possible to discontinue use of controlled substances or uncovering relapse earlier,” he added. “And, third, it protects both the physician and the medical practice from unnecessary liability.”
Within the clinical laboratory industry, the toxicology and pain management sector is recognized to have widespread problems with patient compliance, along with fraud and abuse by numerous lab companies. In order to differentiate itself in the marketplace as a legitimate lab company while delivering a useful benefit to referring physicians, GenoTox took the high road by developing a DNA-based test that matches the urine sample to the patient with an extremely high level of confidence.
Lab administrators, pathologists, and PhDs should consider GenoTox and its ToxProtect assay as examples of how innovative thinking and willingness to invest in developing a useful solution can pay dividends. It is why, in this highly competitive market segment—often marked by abusive sales practices—GenoTox is winning the loyalty of a growing number of physicians because it is helping them achieve better outcomes with their patients.
Contact Michael Willoughby at 512-600- 6601 or firstname.lastname@example.org.