Colorado startup Sundance Diagnostics said it will work with Germany's famed Max Planck Institute of Psychiatry to develop and commercialize a diagnostic blood test that would gauge suicide risk for patients taking antidepressants.
"Our hope is that the new test will assist the physician in significantly reducing the risk of these tragic results and will provide patients and families with valuable personal information to use with their doctors in planning treatment," Sundance CEO Kim Bechthold said in a statement.
Both sides aren't discussing financial details. But the deal calls for Sundance to expand the Munich institute's initial clinical validation of 79 genetic markers that predicted with a 91% probability in an independent study which patients taking antidepressants were at risk of suicide. Another major finding: There was no age difference between patients taking antidepressants who developed suicidal thoughts and those who did not, even though the FDA warns that patients under age 25 face the highest risk.
Sundance said it envisions coming up with a laboratory-developed test for both the United States and Europe. There's a lot to get to before that point, however, including clinical studies to support FDA and CE mark clearance and insurance reimbursement. Plans call for announcing a timeframe in early 2014, Sundance said, with regulatory submissions within a year and a half.
Sundance's deal with the Max Planck Institute expands on an initial mission announced earlier this year to pursue the development of companion diagnostic blood tests to gauge a patient's suicide risk while taking certain antidepressant drugs already on the market. Bechthold told FierceMedicalDevices at the time that it would focus on developing tests to go with Forest Laboratories' ($FRX) Celexa (and generic citalopram) and Lexapro, after which it would target Paxil and Zoloft. Each test, she said, would use whole-genome sequencing of patients and controls.
There is a real market for a viable companion diagnostic in this space, considering that antidepressant drugs lead to an increased risk of suicidal behavior, particularly in the first few weeks of taking them. Also, doctors prescribe more than 9 million new antidepressant medications annually in the U.S. alone, Sundance has said, with 540,000 people out of that total at risk of suicidal thinking. Antidepressant use has jumped 400% from 1988 to 1994 through 2005 to 2008, according to National Center for Health Statistics data cited by the company.
A test that could screen for patients at risk for suicidal thoughts when they take a given drug, helping them steer preemptively toward another better-targeted treatment before problems erupt, would prevent suicide health crises and help manage healthcare costs at the same time.
Sundance launched in 2010.
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