A startup that’s developing a blood test to diagnose the cause of stroke is planning a clinical study that could pave the way to commercial sales of the test.
Cincinnati-based IschemiaCare plans to begin the study in the second half of this year, and the young company has attracted some big-name partners to help it get there — medical device giant Medtronic and genetic analysis company Affymetrix.
“They’ve been helping us develop a sound clinical and operational strategy about how we approach the cryptogenic stroke market,” said IschemiaCare CEO Jeff June.
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IschemiaCare’s blood test, called ISCDX, uses gene expression profiles to differentiate strokes that originate in the heart from those that originate in large blood vessels that lead to the brain.
Typically, a stroke’s cause is diagnosed by a combination of a physical examination, basic lab tests and imaging tools. However, research papers have shown that around 30 percent of strokes are cryptogenic, which means there’s no identifiable cause. The idea behind IschemiaCare’s test is that identifying the cause of stroke will help doctors prescribe therapies that better prevent reoccurrence.
IschemiaCare’s lab will complete the CLIA certification process in the next month and be able to process and analyze blood samples sent by hospital customers. Beginning with the CLIA approach will enable early clinical adoption of the test, while the company’s longer-term goal is to develop a point-of-care test that will require regulatory clearance. Obtaining regulatory clearance from the U.S. Food and Drug Administration would enable IschemiaCare’s customers to perform the blood test in their own labs.
Affymetrix is helping IschemiaCare with the process of transitioning its test from a research lab to a commercial lab. The basic goal is to ensure that test results obtained in the research lab match those obtained in the CLIA lab while maintaining regulatory compliance, said Roger Schaller, Affymetrix’s senior director of global business development in molecular diagnostics.
Schaller sees promise in personalized tests like IschemiaCare’s that tailor treatment based on a patient’s genetic profile. “With these types of tests, they’ll be able to rifle shot what type of treatment plan a patient should get,” he said.
Medtronic is helping IschemiaCare design protocols for the pilot study, said Jaimie Mattson, a marketing manager with the Minneapolis-area device company.
IschemiaCare plans to conduct the pilot study at up to six major stroke centers, according to June.
Aside from the study, IschemiaCare has another looming milestone it’s aiming at: June hopes to secure a $6 million series C investment by the end of the year. Cincinnati angel group Queen City Angels led IschemiaCare’s $800,000 series B round last year.
“Working with partners like Medtronic and Affymetrix is like skipping raising a round of capital, and it also aligns us with commercial channels more effectively than a round of capital would,” June said.
