TETmedical Receives FDA Breakthrough Device Designation for First Rapid Blood Test to Aid Ischaemic Stroke Diagnosis

TETmedical has received Breakthrough Device Designation from the US Food and Drug Administration for NSE-FAST®, a rapid in vitro diagnostic test designed to aid in the diagnosis of acute ischaemic stroke. The designation recognises the potential of the technology to improve the early detection of one of the most common and serious neurological emergencies.

Acute ischaemic stroke occurs when blood flow to the brain is blocked and accounts for the majority of stroke cases. Early diagnosis is essential to improve treatment outcomes, yet conventional imaging methods, such as CT scans, may not always detect the condition during its initial stages. Delayed diagnosis can lead to missed treatment opportunities and increased risk of long-term disability.

NSE-FAST® is an enzyme-based luminescence assay that measures the functional activity of neuron-specific enolase, a biomarker associated with acute ischaemic stroke. 

Using TETmedical’s patented Tethered Enzyme Technology, the test analyses a patient's blood plasma and is intended to support clinical assessment alongside other diagnostic information. 

The rapid blood-based approach aims to help clinicians identify stroke earlier and make faster treatment decisions in emergency care settings.

The FDA's Breakthrough Devices Program is intended to accelerate the development and review of technologies that address life-threatening or irreversibly debilitating conditions where effective diagnostic or treatment options are limited. 

The designation provides TETmedical with increased regulatory support during product development and review.

The company plans to begin a multi-centre pivotal clinical study in the fourth quarter of 2026, with patient enrolment expected to conclude in 2027 before submitting the technology for FDA marketing authorisation.