The assay measures enzyme activity in plasma to help clinicians identify acute ischemic stroke, which is often missed by standard imaging.
The Food and Drug Administration (FDA) granted Breakthrough Device Designation to TETmedical for its NSE-FAST assay, a rapid blood test designed to help diagnose acute ischemic stroke. The designation, issued by the FDA Center for Devices and Radiological Health, is intended to speed up the development and review of medical devices that treat or diagnose life-threatening conditions.
NSE-FAST is a rapid, enzyme-based luminescence assay that measures the functional enzymatic activity of neuron specific enolase in the blood plasma of a patient. The test is intended for use alongside other clinical information to assist in the diagnosis of acute ischemic stroke in adult patients.
Addressing Diagnostic Gaps
Stroke is a leading cause of death and long-term disability in the US, with approximately 840,000 Americans suffering an acute stroke annually. About 87% of these cases are ischemic, which occurs when blood flow to the brain is obstructed.
While computed tomography scans are effective at identifying hemorrhagic strokes, they frequently fail to detect acute ischemic strokes. According to a study published by the Agency for Healthcare Research and Quality, stroke is the top clinical condition associated with serious misdiagnosis-related harms, with an average of 17% of strokes missed.
“This designation represents an important recognition of NSE-FAST and its potential to address one of medicine’s most significant unmet diagnostic needs,” says David Fischell, Co-Founder and CEO of TETmedical, in a release.
Clinical Development Timeline
The Breakthrough Device Designation provides the company with prioritized access to FDA experts and the potential to align with clinical and regulatory requirements during the development process. The assay may also be considered for the Regulatory Alignment for Predictable and Immediate Device coverage pathway, an initiative designed to reduce the time between FDA authorization and Medicare coverage decisions.
“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,” says Fischell in a release. “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.”
TETmedical plans to initiate a multi-center pivotal study in the fourth quarter of 2026. The company anticipates completing patient enrollment in the second half of 2027, with plans to submit its marketing application to the FDA by the fourth quarter of 2027.
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