FAST>ER™ is a rapid biomarker platform designed to support time-critical clinical assessments when evaluating patients with stroke-like symptoms. By providing objective biochemical insight, it helps clinicians better identify patients who may be experiencing an acute stroke.
A Persistent Challenge in Time-Critical Care
In acute and rapidly evolving medical conditions, clinicians are often required to make critical decisions before complete information is available.
Several limitations can complicate early evaluation:
- Imaging reveals structural changes but does not always indicate biological timing
- Clinical assessments may vary and can sometimes be subjective
- Centralized laboratory testing may take too long in urgent situations
As a result, objective biomarker insight is often unavailable at the point of care precisely when rapid clinical decisions must be made.
Introducing FAST>ER™
FAST>ER™ is a rapid point-of-care biomarker assay designed to provide objective biochemical information during time-critical clinical evaluations.
The system measures GSTP, a biomarker associated with cellular stress and injury. By detecting GSTP levels quickly, FAST>ER™ aims to complement existing diagnostic tools by introducing molecular insight earlier in the patient care pathway.
Rather than replacing current clinical assessments or imaging technologies, FAST>ER™ is designed to add another layer of information that may help clinicians better understand the biological context of a patient’s condition.
Why Biomarkers Matter
Biomarkers provide a direct window into biological processes that may not yet be visible through imaging or physical examination.
In time-critical injuries and diseases:
- Cellular stress may occur before structural changes are visible
- Symptoms can be nonspecific and difficult to interpret
- Early biological signals may help inform downstream care decisions
Biomarker insight can help clinicians contextualize what is happening biologically in real time, supporting more informed clinical assessments.
A Biomarker Platform for Future Applications
FAST>ER™ represents the first clinical application of a broader biomarker platform currently under development.
Future research and development efforts are exploring potential applications across several areas of medicine, including:
- Acute neurologic injury
- Neonatal hypoxia
- Oncology
- Veterinary and animal health
Ongoing platform development will continue to follow scientific validation processes and applicable regulatory pathways.
How FAST>ER™ Works
- A small blood sample is obtained at the point of care
- GSTP is detected using a proprietary immunoassay
- Results are generated within minutes
- Biomarker insight becomes available to support clinical evaluation
FAST>ER™ is designed to integrate into existing clinical workflows without delaying patient care.
Clinical Validation & Regulatory Alignment
FAST>ER™ is being evaluated through established clinical validation and regulatory pathways appropriate for biomarker-based diagnostics.
- Clinical studies designed to align with standard reference methods
- European and U.S. regulatory strategies under evaluation
- Ongoing collaboration with clinical and academic partners
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