MUNICH, Germany—Seeking to commercialize a genetic diagnostic test that can reduce the incidence of suicide in patients taking antidepressants, Boulder, Colo.-based Sundance Diagnostics has licensed technology from Germany’s Max Planck Institute of Psychiatry.
The financials are not being disclosed by the privately held Sundance, said company CEO Kim Bechthold, though she did say Sundance is taking over patent costs and will pay a sales-based royalty to the Planck Institute. The test will be ready within the next month or two, she said, adding that licensing agreements with commercial lab companies around the country are in the works.
Based on research published in Neuropsychopharmacology in 2011, the test looks at a patient’s full genome for 79 markers of risk of emergent suicidal ideation. Initial research identified those markers, but then the Planck researchers, led by Andreas Menke and Elisabeth Binder, sought insight into the predictive power of those markers.
“When they tested their markers against 500 new patients, they could actually predict about 90 percent correct,” Bechthold says. “For a laboratory test, it’s out of this world.”
There are some limitations on the results, including that the test was only applied to Caucasians and people over the age of 18, though Bechthold admitted “every age of child is being prescribed antidepressants.” She also noted that teens are among the least likely to seek additional help for their depression and are also at risk of not telling their parents what their true thoughts and feelings are.
But the promise is so strong, Bechthold said, that Sundance will work to extend the test results to greater numbers and more diverse populations (including people of Asian and African descent), as well as potentially people under 18. The company will also seek approval from the U.S. Food and Drug Administration, which will allow the company to make claims about the test’s predictive power. Bechthold expects that approval within 18 months.
In the Planck Institute research, people at low risk of emergent suicidal ideation were identified correctly 93 percent of the time, Bechthold said. Those at high risk were identified less successfully, but she said even that division could be very useful, allowing physicians to focus their attention on those patients who are likely to be more at risk.
The market is massive: According to the U.S. Centers for Disease Control and Prevention, 11 percent of Americans age 12 and up are already taking antidepressants, and 9 million new prescriptions are written each year in the United States (as of 2006, so current numbers are likely higher). A further 9 million new prescriptions are written worldwide each year. At $200 to $300 per test, Bechthold said, “the potential profit is $1.8 billion.”
And the test is attractive, because no studies have been able to identify clinical indicators for doctors to detect emergent suicidal ideation induced by antidepressant drugs, leaving them operating in the dark even as they write more and more prescriptions. Rather than putting millions at risk every year—it is estimated that between 6 percent and 13 percent of the population is susceptible to antidepressant-induced emergent suicidal ideation—they can screen patients with a rapid cheek-swab test administered in the office. Results come back from the lab within two days, an important factor since 97 percent of patients who develop this adverse reaction do so within the first 29 days.
“This is a window into something [the doctor] simply can’t guess and has no way of knowing,” Bechthold said.
Adding to the demand for the test may be an additional result of the Planck research. Since 2005, all antidepressant prescriptions in the U.S. have carried a suicide warning, and there is an additional warning targeting patients 25 and under, who have been deemed by the FDA to be at elevated risk as compared to older patients.
National Institute of Mental Health research has shown, however, that there is no age at which risk is higher or lower; the Planck research confirmed that finding in its population, which ranged in age from 18 to 75.
Bechthold said Sundance, which focuses on adverse drug response and genetics, knows that genetic tests are commonplace in treatments for cancers and infectious diseases and is looking forward to bringing the first genetic test into neuropsychiatry. The company will work with Planck on further research in this and other areas.