ABCDx
ABCDx specializes in the discovery, clinical validation, and commercialization of brain mobile diagnostic solutions with advanced blood-based biomarkers through its proprietary Software as a Medical Device platform. The company is dedicated to developing innovative diagnostic tools for brain injuries, stroke, and traumatic brain injury, aiming to improve patient outcomes through rapid, accurate, and accessible point-of-care diagnostics. With headquarters in Switzerland and Spain, ABCDx is committed to advancing medical technology and transforming emergency care for brain injury patients.
Industries
Nr. of Employees
small (1-50)
Products
Rapid point-of-care LVO stroke blood test (pre-hospital use)
A portable, finger-prick blood test designed to detect biomarker signatures associated with large vessel occlusion to support rapid triage in prehospital settings.
Point-of-care TIA biomarker test (H-FABP based)
A rapid point-of-care test designed to quantify heart fatty-acid binding protein levels to aid diagnosis of transient ischemic attack in emergency and primary care settings.
Point-of-care TBI rapid test (mild traumatic brain injury)
A rapid, portable blood test for early detection of mild traumatic brain injury using a panel of biomarkers intended for sports and clinical environments.
Regulated diagnostic decision-support app (CE marked)
A medical software application for collecting diagnostic data and supporting clinical decision-making at the point of care that has undergone CE conformity assessment.
Rapid point-of-care LVO stroke blood test (pre-hospital use)
A portable, finger-prick blood test designed to detect biomarker signatures associated with large vessel occlusion to support rapid triage in prehospital settings.
Point-of-care TIA biomarker test (H-FABP based)
A rapid point-of-care test designed to quantify heart fatty-acid binding protein levels to aid diagnosis of transient ischemic attack in emergency and primary care settings.
Point-of-care TBI rapid test (mild traumatic brain injury)
A rapid, portable blood test for early detection of mild traumatic brain injury using a panel of biomarkers intended for sports and clinical environments.
Regulated diagnostic decision-support app (CE marked)
A medical software application for collecting diagnostic data and supporting clinical decision-making at the point of care that has undergone CE conformity assessment.
Services
Biomarker discovery and IP generation
Discovery of blood-based brain injury biomarkers using proteomics and translational research to create patentable biomarker candidates.
Clinical study design and multi-center execution for POC diagnostics
Design and coordination of multi-center clinical protocols, patient recruitment and training of emergency teams for prehospital diagnostic validation.
Assay development partnerships and OEM coordination
Collaborative assay optimization and transfer to diagnostic OEMs for lateral flow or other POC formats, including reagent selection and feasibility testing.
SaMD development and digital platform integration
Development of regulated digital platforms and medical cloud solutions to integrate point-of-care test results, algorithms and workflows for clinical decision support.
Regulatory strategy and submission support
Regulatory planning and support for device and IVD approvals, including guidance on FDA pathways, CE marking, IVDR alignment and relevant ISO standards.
Biomarker discovery and IP generation
Discovery of blood-based brain injury biomarkers using proteomics and translational research to create patentable biomarker candidates.
Clinical study design and multi-center execution for POC diagnostics
Design and coordination of multi-center clinical protocols, patient recruitment and training of emergency teams for prehospital diagnostic validation.
Assay development partnerships and OEM coordination
Collaborative assay optimization and transfer to diagnostic OEMs for lateral flow or other POC formats, including reagent selection and feasibility testing.
SaMD development and digital platform integration
Development of regulated digital platforms and medical cloud solutions to integrate point-of-care test results, algorithms and workflows for clinical decision support.
Regulatory strategy and submission support
Regulatory planning and support for device and IVD approvals, including guidance on FDA pathways, CE marking, IVDR alignment and relevant ISO standards.
Expertise Areas
- Proteomics-driven biomarker discovery
- Point-of-care diagnostic development and validation
- Clinical trial design and multi-center study management
- AI-driven diagnostic algorithm development
Key Technologies
- Proteomics-based biomarker discovery
- Lateral flow immunoassay development
- Point-of-care testing for finger-prick whole blood
- AI-driven biomarker panel selection algorithms