Clinical trials are underway for what could be a first-of-its-kind blood test that would help doctors determine what caused a patient to have a stroke.
Developed by Cincinnati-based Ischemia Care, the test isolates RNA from whole blood and examines immune responses, with the goal of differentiating where an ischemic stroke originated in a patient’s body.
Stroke is normally diagnosed through physical examinations and diagnostic imaging. But in about one-third of cases, doctors aren’t able to identify a cause. Being able to determine whether the stroke originated in the heart or in the blood vessels could have a huge impact on how patients are treated and on preventing recurrent strokes, said CEO Jeff June. About a quarter of the 800,000 Americans who have a stroke each year will go on to have another one, which carries a higher risk of death and disability.
The idea behind Ischemia Care’s test, ISCDX, is that a physician would order it for patients who present with stoke symptoms. They would draw a vial of blood, send it to the company’s CLIA-certified lab and expect results within four to five days. That’s a critical time frame because most patients who have a stroke are hospitalized for five to 12 days, June said, so if physicians know what caused the stroke within that time frame, they can get a patient started with the proper treatment regimen before leaving the hospital. The ultimate goal of the company is to develop a point of care test that can stratify patients within hours of an event.
“We have a much better understanding of the market and the uptake,” June said, recalling the last time he talked to MedCity News about the company nearly two years ago. “Before, we looked at ischemic stroke and could discern between originating in the heart and blood vessels. Now we also look at patients who come in the door with suspected stroke, a transient ischemic attack or some perceived neurological deficit.”
Another important feature the company has added to its test is the ability to differentiate between ischemic strokes that originate in the heart and are caused by atrial fibrillation, and those that originate in the heart but aren’t caused by AF.
“This is often missed in early clinical assessment of patients because many times when patients are evaluated for stroke, they’re not in A-fib,” June said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
While other blood tests might provide hints that a patient has had a stroke, June said this is the first technology he’s aware of that identifies immune response based upon the cause of stroke. It’s being evaluated in a 600-patient clinical trial already underway at Cleveland Clinic and The Medical University of South Carolina, with plans to bring three other sites onto the study, he said. He’s hoping to have results by the third quarter of this year.
Ischemia Care is focusing its early efforts toward clinical adoption on the nearly 800 U.S. hospitals designated as Primary Stroke Centers. Although it’s taking the CLIA-lab approach initially, June said the long-term strategy involves a blood test that could be done at the point of care.
Ischemia Care, founded in 2009, has designed the study and the test with help from partners including Medtronic and Affymetrix. It’s been financed both by grants and by investors — most recently a $750,000 round in December. Previously, the company raised a $1.1 million round led by Cincinnati’s Queen City Angels. June said the company is actively looking for a corporate partner or for venture investors.
