NeuroMark Launches Suicidal Ideation Dx For Investigational Use Pending Final Study | GenomeWeb
NeuroMark this week clarified that its Mark-C genetic test for suicidal ideation in patients treated with citalopram will be launched for investigational use only, pending positive results from two confirmatory trials. The firm will initially debut the test as a homebrew assay, which will likely make it the first genetic test for suicidal ideation.
The company said it plans to submit the test for FDA approval in 2008, but has not yet determined whether to submit under a 510(k) or for premarket approval.

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