Sundance Diagnostics is pursuing a novel path for companion diagnostics development--blood tests that will gauge a patient's risk for suicide while taking certain antidepressant drugs already on the market.
The Colorado company made the initial announcement this week. CEO Kim Bechthold told FierceMedicalDevices via email that Sundance is first focusing on a companion diagnostic test for Forest Laboratories' Celexa (and generic citalopram) and Lexapro. After that, the company will focus on Paxil and Zoloft next. Sundance aims to have the test identify "all unique biomarkers by using whole genome sequencing of patients and controls," Bechthold explained.
Antidepressant drugs create an increased risk of suicidal behavior particularly in the first few weeks of taking the treatment, and regulators in the U.S. and Canada require warnings for all classes of the medications. Consider, also that doctors prescribe more than 9 million new antidepressant medications annually in the U.S. alone, according to statistics cited by the company, putting at least 540,000 people out of that number at risk of suicidal thinking.
That means a companion diagnostic arguably has enormous market potential and need. What the company hopes to have in the long run is a test that each patient could take before taking an antidepressant. If a person is at risk, then avoiding the drug would steer away from side effects, additional care needs and maybe even save insurance costs, the company believes.
At least one other group of researchers is focused on developing a diagnostic blood test relating to suicide risk. Scientists at the University of New South Wales in Australia, and Swedish colleagues are developing a diagnostic blood test that could gauge higher-than-normal levels of the neurotransmitter quinolinic acid, which has been linked to severe depression or suicidal states. It would not be paired with a specific drug, however.
Down the line, Sundance also wants to develop companion diagnostics for drugs that cause violent behavior in some patients. The company launched in 2010 and employs 11 people. As Bechthold told us, the company is "privately held by individual investors" and has "received one $250,000 research grant to date."
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