Genotox Laboratories, Austin, Tex, has developed ToxProtect, which adds a cheek swab to the urine-collection process so that the DNA of the person being tested can be matched to the urine they provide.

According to the company, an entire industry has sprung up to help drug-test cheaters, with products such as substitute urine and synthetic urine easily available on the internet.

Photo McCarty Matt

Matt McCarty, MD, Genotox Laboratories.

“With a DNA test, there’s no maybe about it,” says Matt McCarty, MD, CEO and founder of Genotox Laboratories. “It either matches, or it doesn’t match.”

McCarty says the development of ToxProtect couldn’t have come at a more critical time, with the growing opioid epidemic in the United States. On an average day, 91 Americans die from an opioid overdose, and since 1999 the number of overdose deaths involving opioids has quadrupled, according to the US Centers for Disease Control and Prevention. Much of the problem involves prescription drugs rather than illicit drugs.

“But whether it’s a legal issue or a medical issue doesn’t matter,” McCarty says. “These are human beings who need help to get past an addiction. They are ruining their lives.”

McCarty, who specializes in chronic pain management, became intrigued with finding a way to outwit drug-test cheaters when he began using the tests to monitor his patients and immediately saw the weaknesses. In 2014, a year after Genotox Laboratories opened, he began the studies that would lead to ToxProtect.

“Our test will discover misuse, abuse, and relapse when other tests won’t,” McCarty says. “It’s especially helpful for physicians who will know for certain if a patient they test is using synthetic or substitute human urine.”

According to a company spokesperson, Genotox does not currently have plans to submit the test for FDA premarket review. While the test is not a diagnostic in its own right, it seeks to provide an essential means of authenticating patient specimens provided for testing.

For more information, visit Genotox.