NVL1 for Diagnosing PTSD
We are developing a companion diagnostic for our PTSD treatment program. To this end we have designed a GluA1 measurement process in the amygdala using radiation imaging technology with a novel tracer. Our patent-pending tracer, NVL-1, was developed in mid-2017. Optimization as well as pre-clinical validation are underway, with clinical trials expected to begin late 2018.
Currently, PTSD is diagnosed with checklists after symptoms have manifested. The checklist method (using either the Structured Clinical Interview for DSM (SCID) – PTSD Module, or the Clinical Administered PTSD Scale (CAPS)/Life Events Checklist) is subjective. Furthermore, the reliance on self-report and self-assessment leads to both under-diagnosis and mis-diagnosis.
By definition, the conventional PTSD diagnosis requires manifestation of symptoms. The diagnostic criteria (DSM-V) include Exposure to a traumatic stressor (criterion A), reexperiencing, avoidance/numbing, and hyperarousal symptoms (criteria B through D), duration of at least one month (criterion E), and clinically significant distress or impairment in social/occupational functioning (criterion F). American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders. (5th ed.). Washington, DC: Author.
We aim to diagnose PTSD far sooner based upon the GluA1 “biomarker.” This protein will provide an objective indication of PTSD in a patient, irrespective of manifestation of symptoms, and can be used as an enrollment tool for future treatment studies.
Our diagnostic tracer has potential applications beyond PTSD for use with other GluA1-implicated disorders, such as ALS, epilepsy, and Alzheimer’s.