BOULDER, Colo. -- (BUSINESS WIRE) -- Sundance Diagnostics, Inc., a Boulder, CO diagnostics development company, announced today that it will focus on risk of suicide and the potential risk of acts of violence in development of its genetic tests designed to curb prescription drug side effects.
The first test to be developed is for the risk of medication-induced suicidal thinking and behavior—a known serious side effect of antidepressant drugs. Following that, Sundance plans to investigate genetic markers for risk of medication-induced acts of violence—a potential prescription drug side effect.
“The importance of genetic tests to curb the risk of suicide and risk of acts of violence has been heightened as governments and communities search for effective ways to halt tragic mass shootings,” said CEO Kim Bechthold.
David Healy, MD, FRCPsych, British psychiatrist, psychopharmacologist, scientist, author, and leading advocate of public reporting of drug side effects, said, "Somewhere around 90% of the school or other mass shootings that have happened in recent years in America or Europe have involved shooters on psychotropic drugs, usually anti-depressants…These are people in treatment whose doctors clearly failed to recognize the risks they [the medications] posed.”
The US Food and Drug Administration (FDA) and regulatory agencies in Canada and Europe have required a “black box” warning of antidepressant-induced risk of suicide for all classes of antidepressant medications since 2005. Canadian agencies warn of risk of antidepressant-induced violence as well. In 2007, the FDA modified its warning to include heightened antidepressant-drug risk during the first weeks of treatment.
If successful, the new tests will be available for each patient before a drug is prescribed. The physician can then take action appropriate for the patient throughout the course of therapy. Family members, who before now may not have been advised of antidepressant medications’ side effects, can be informed of the patient’s specific risk and can actively participate in ensuring the safety of the patient during treatment, helping to determine the level of monitoring that is warranted and making decisions on complementary therapies and alternatives to medication.
It is anticipated that the genetic tests will result in a reduction in healthcare costs and insurance costs and will significantly improve patient care.
There are over 9 million new prescriptions written per year for antidepressant medications in the United States. This figure means that annually an estimated 540,000 persons will be at risk for the medication side effect of suicidal thinking or behavior.
The SSRI drugs and the smoking cessation drug Chantix are the most strongly and consistently implicated drugs associated with reports to the FDA of acts of violence toward others.
About Sundance Diagnostics, Inc.
Sundance Diagnostics, Inc., based in Boulder, Colorado, is in the business of developing genetic companion diagnostic tests to curb the risk of side effects from major market, prescribed medications. The company has assembled a group of leading scientific and medical experts in genetics, next-generation sequencing technology, diagnostic test development and psychiatry.