Rapid Blood Test Aids Diagnosis of Acute Ischemic Stroke

In the U.S., emergency departments evaluate an estimated 2.3 million patients each year for stroke-like symptoms, while a recent study found that approximately 17% of strokes are initially missed. To help address this diagnostic gap, a new rapid blood test has received U.S. FDA Breakthrough Device Designation to aid in the diagnosis of acute ischemic stroke.

The NSE-FAST (Neuron Specific Enolase — Functional Activity Stroke Test) from TET Medical (Fair Haven, NJ, USA) is positioned as the first rapid test designed to aid in the diagnosis of acute ischemic stroke. On June 15, 2026, the U.S. Food and Drug Administration (FDA) granted the test Breakthrough Device Designation through the Center for Devices and Radiological Health, Division of Immunology and Hematology Devices. The company is a clinical-stage medical diagnostics developer focused on near-patient tools for acute neurological injury.

NSE-FAST is a rapid, enzyme-based luminescence assay that quantifies the functional enzymatic activity of neuron specific enolase in blood plasma. The assay leverages TETmedical’s patented Tethered Enzyme Technology to directly measure this activity as a biomarker of acute ischemic stroke. It is intended for use in adult patients alongside other available clinical information to support diagnostic decision-making.

The Breakthrough Devices Program is intended to speed development and review of technologies that may offer more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions with no approved alternatives. The designation provides prioritized access to FDA expertise and enhanced interactions to help align clinical and regulatory requirements, but it does not change marketing authorization standards or guarantee clearance or approval.

TETmedical plans to begin a multicenter pivotal study of NSE-FAST in the fourth quarter of 2026, with anticipated completion of patient enrollment in the second half of 2027 and a planned marketing submission by the fourth quarter of 2027. The designation may also position the test for consideration under the emerging FDA-CMS Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which requires additional criteria and is not guaranteed.

“This designation represents an important recognition of NSE-FAST and its potential to address one of medicine’s most significant unmet diagnostic needs. Acute ischemic stroke remains the leading missed diagnosis causing serious harm in emergency medicine. We are gratified that the FDA has recognized the potential of the NSE-FAST to help address this longstanding challenge. We are fortunate that the NSE-FAST needs but a single additional small tube of blood collected under IRB approvals with a waiver of patient informed consent,” said Dr. David Fischell, Co-Founder and Chief Executive Officer of TETmedical.

“We look forward to working closely with the agency as we advance the NSE-FAST through our pivotal study toward our goal of bringing the first rapid blood test for ischemic stroke to patients and physicians,” said Dr. Fischell.

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