About ISCDx Testing
About ISCDx Testing
The ISCDx test uses gene expression to identify the cause of stroke during the hospital admission following acute treatment, to enable a targeted and personalized approach can be implemented to minimize the risk of recurrence.
The ISCDx test reports the likely cause of stroke (cardioembolic versus large artery atherosclerosis) based upon a blood draw, collected when a patient presents within 30 hours of symptom onset, and intended to be used in the normal course of care to aid in the diagnosis and treatment of stroke for secondary prevention.
ISCDx is the first blood test for stroke to complete the CLIA analytical process and is available today. Ischemia Care testing is offered under the Clinical Laboratory Improvements Amendments program (CLIA) as a Laboratory Developed Test (LDT). The CLIA program oversees clinical testing in over 264,000 US laboratories, with oversight from the Centers of for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC).
ISCDx provides a new source of information that empowers clinicians to streamline patient workflow to confirm the most likely cause while eliminating other more invasive, high cost, or low yield testing.
Implement blood testing in standard hospital workflow
Ischemia Care has developed an implementation program to assist each hospital in understanding the clinical and economic impacts of ISCDx test adoption. The goal of this program is to inform hospital decisions about patient selection, testing logistics, and possible changes in workflow balanced with economic impact.
A common approach to implementation is to include ISCDx as part of Basic evaluation for ischemic stroke patients that frequently includes CT, MRI, vessel imaging, telemetry, and basic blood labs. The ISCDx test indicates the likely cause of an ischemic stroke (i.e. cardioembolic versus large artery atherosclerosis) to be used in guiding additional Advanced or Specialized testing.
To send a sample, Ischemia Care will provide a hospital laboratory with an ISCDx collection kit that requires a blood draw performed within 30 hours of symptom onset. The hospital laboratory will then send this sample to Ischemia Care for processing and reporting.
The ISCDx test results are considered alongside the current standard of care diagnosis (TOAST, CSS) to determine appropriate advanced diagnosis at treatment pathway that will lead to optimal guideline directed care for secondary prevention.
Examples of the ISCDx test when used in the routine course of care:
Increase likely success of additional tests that otherwise would not have been considered because it is traditionally "low yield" or expensive.
Reduce marginally effective and invasive procedures.
Reduce length of stay.
Increase confidence in the early diagnosis.
Reduction in the number of crytogenic patients, including those due to undetected atrial fibrillation which convey a high recerrence rate.
Please contact us to walk through scenarios specific to your patient populations and challenges so we may provide you with very specific examples. With any new technology there are always questions, which we look forward to addressing.
Over fifteen years of NIH funded research created the foundation for Ischemia Care's testing and intellectual property. Early clinical data demonstrated unique patterns of gene activity measured in RNA isolated from whole blood, known as gene expression, changed in response to a stroke and could be used to uniquely identify cause.
Ischemia Care conducted the Biomarkers of Acute Stroke Etiology (BASE) clinical trial to further develop and validate blood based diagnostic testing for stroke. The BASE trial concluded enrollment in late 2019 and recruited over 1700 subjects from 20 stroke centers. Ischemia Care applies advanced machine learning to analyze the large data sets generated from the BASE clinical trial. BASE data is published and presented by leaders in the field of stroke.
For hospitals interested in adding this advanced molecular testing to their portfolio, our team will work closely with your clinicians to understand existing protocols and discuss the potential impact on both patient outcomes and cost of care.
Please contact our team to make the test available at your facility