RAPID-Dx: Research Alliance for PTSD/TBI Innovation and Discovery Diagnostics
NEW SCIENTIFIC TOOLS OFFER A COMPREHENSIVE VIEW OF GENE, PROTEIN AND METABOLIC ACTIVITY, BRAIN CIRCUITS, AND PHYSIOLOGY – AND MAY ENABLE US TO DISCOVER NEW BIOMARKERS FOR PTSD OR TBI AND DEVELOP PRECISION DIAGNOSTIC TESTS.
The Challenge: PTSD diagnosis is subjective, based solely on symptoms experienced by the individual and assessed through interview
Our Goal: Discover and validate biomarkers and develop diagnostic tests to guide diagnosis and treatment of PTSD and related disorders
Our Solution: The RAPID-Dx Alliance
RAPID-Dx is CVB’s flagship biomarker discovery collaborative – fast-tracking the advancement of objective diagnostics for PTSD and TBI.
A biomarker is a characteristic that is objectively measured and evaluated as an indicator of a normal or pathologic biological process or a response to a therapeutic intervention.
Developing biomarker-based diagnostics is essential to shifting diagnosis & treatment of PTSD and TBI from a syndromic, symptom-based approach to a biological, mechanistically-based one that targets the effects of trauma at their molecular roots. Many potential biomarkers of PTSD & TBI published in the literature have not been independently replicated or advanced through a qualification process for regulatory approval and use.
RAPID-Dx is collecting data and performing studies necessary to discover and replicate biomarkers and qualify successful and relevant candidates for development as clinical diagnostics.
RAPID-Dx is bringing together large, well-characterized cohort studies of PTSD and TBI. To accelerate the biomarker discovery process, investigators will collaborate and share large biomarker and imaging legacy datasets in a centralized, cloud-based data platform, the BRAIN Commons, for interrogation by a multi-disciplinary group of experts in clinical, biomarker, and computational research. RAPID-Dx will also support the large-scale analysis of stored biosamples on high-precision, bioassay platforms to generate data for well-powered, multi-modal biomarker discovery and fuel systems biology modeling efforts of disease. Key stakeholders in the biomarker development and qualification process, including regulatory experts and industry affiliates, have been engaged early on to ensure impactful biomarker discoveries can be translated to clinical application.
Establish and advance a Roadmap for discovery, replication and qualification of biomarkers for PTSD and TBI diagnostics (and co-morbid conditions).
Evaluate the performance of the most advanced, validated bioassay platforms
Identify the most promising bio-fluid and imaging biomarkers in PTSD and trauma-related disorders based on published literature
Leverage legacy PTSD & TBI biomarker datasets and bio-fluid samples that are available for analysis
Develop statistical analysis plans for biomarker discovery and replication based on context of use and informed by regulatory guidance
Utilize the Brain Commons for advanced analytics and to share results with the community
Develop and disseminate best practice approaches for biomarker discovery, replication and validation.
Identify gaps in the biomarkers & diagnostics portfolio requiring new research & investment.
“The fastest way to help Veterans living with TBI and PTSD is to break down the traditional silos of science and scientific resources. By joining RAPID-Dx, we are affirming our commitment to a new type of radically collaborative science de ned by data sharing and coordination of efforts toward our shared goal of finding clinically-useful diagnostics and treatments for these invisible wounds of war. There is no doubt in my mind that coordinated team science will accelerate progress toward diagnosis and treatments. We are thrilled to be working with Cohen Veterans Bioscience.” – Rachel Ramoni, DMD, ScD, Chief Research and Development Officer at the Veterans Health Administration
Cohen Veterans Bioscience is a nonprofit 501(c)(3) research organization dedicated to fast-tracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders.