State of the art CLIA laboratory providing information leading to clinical evidence-based care
Ischemia Care testing has completed the Clinical Laboratory Improvement Amendments (CLIA) analytical validation process. The rigorous CLIA standards oversee clinical testing in 260,000 US laboratories. The CLIA program receives oversight from the FDA, CMS, and CDC.
BASE - a major clinical trial to validate the use of blood biomarkers in stroke care
The Biomarkers of Acute Stroke Etiology (BASE) was a 1,700 patient prospective IRB approved observational multisite clinical trial (NCT02014896) that concluded enrollment in 2020 designed to validate the use of biomarkers in the acute hospital setting to determine the (i) if a stroke occurred, (ii) the cause of the stroke so the appropriate diagnosis and secondary prevention protocols may be adopted, (iii) identify significant comorbidities such as atrial fibrillation, and (iv) determine if an acute neurological presentation is a stroke, transient ischemic attack, or a transient neurological event.
Clinical Need
Blood testing for stroke patients as a clinical workflow tool to improve patient care and reduce hospital costs, by empowering clinicians with new information.
Products
ISCDx, differentiates cardioembolic from large artery atherosclerosis cause of stroke to improve secondary prevention and reduce cryptogenic or "unknown" cause of stroke.
Pipeline
The BASE clinical trial recruited patients to develop and validate blood tests covering 2 million US hospital presentations for ischemic stroke, atrial fibrillation, transient ischemic attacks, and transient neurological events.
Science
Ischemia Care is an artificial intelligence company pioneering diagnostic blood tests for stroke using RNA expression based on strong clinical data.
ABOUT
Ischemia Care (ISC) uses blood testing for stroke patients as a clinical workflow tool to improve patient outcomes and reduce hospital costs, by empowering clinicians with new information.
Identifying, diagnosing, and treating stroke is difficult. 2M patients arrive in US hospitals annually with suspected stroke. 800,000 of these patients will be diagnosed with a stroke. 250,000 stroke patients never have cause determined (“cryptogenic”) resulting in patient anxiety, clinician frustration, increased costs, and potential higher risk of a recurrent stroke. Recurrent strokes are more massive, debilitating, and costly. Identifying cause enables guideline directed patient care to reduce recurrent stroke risk.
In Sept 2019, ISC launched the first clinically available stroke blood test, ISCDX, a “in hospital” test using gene expression (RNA) to differentiate major stroke causes, including cardioembolic strokes due to atrial fibrillation. ISCDX is a CLIA registered LDT governed under CMS. Future tests will focus on emergent stroke care in emergency room and ambulatory settings.
ISC completed BASE (Biomarkers of Acute Stroke Etiology NCT02014896), a 1700 patient, 20 site, clinical trial resulting in patient data supporting a pipeline of multiple tests answering key clinical questions in stroke care, that today are difficult and expensive to answer. BASE clinical trial data is published and presented at major conference.
CONTACT
Administrative Offices
Inquiries
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CLIA Laboratory
Administrative Offices
347 South College Avenue, Suite B
Oxford, OH 45056
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Tel: 877.490.5067
Fax: 866.437.2899
CLIA Laboratory
100 Campus Loop Drive
Middletown, OH 45005
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Tel: 877.490.5067
Fax: 513.795.5034