Spear Bio Secures FDA Breakthrough Device Designation for its Novel pTau 217 Blood Test, Advancing Scalable Solutions for Early Alzheimer's Disease Diagnosis

Spear Bio Inc., announced that its pTau 217 blood test has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognizes the test's potential to address a critical unmet need for the millions of Americans living with Alzheimer's disease and not yet diagnosed.

Early diagnosis of Alzheimer's disease, a progressive and life-altering condition impacting both patients and caregivers, is essential for improving outcomes and enabling timely access to emerging treatments. Current diagnostic methods, such as PET scans and lumbar puncture cerebrospinal fluid (CSF) analysis, are invasive, costly, and logistically challenging. Plasma pTau 217 has been endorsed as an Alzheimer's disease "Core Biomarker" by the National Institute on Aging, the Alzheimer's Association, and leading researchers and clinicians. However, accurately measuring the very low levels of pTau 217 in plasma requires sensitivity and specificity beyond the reach of conventional immunoassay platforms.

Spear Bio's pTau 217 plasma assay uses a wash-free workflow building on well-established and robust real-time PCR technology as the readout method. The test is intended to be used as an aid in the diagnosis of Alzheimer's disease and help distinguish it from other neurological conditions. It will provide a convenient, accessible, and less invasive alternative for identifying or dismissing the presence of amyloid pathology. This will empower clinicians to diagnose Alzheimer's disease earlier and more efficiently, broadening patient access to critical interventions.

"Receiving FDA Breakthrough Device Designation for our pTau 217 blood test marks an important milestone for Spear Bio." said Feng Xuan, PhD, Co-Founder & CEO of Spear Bio. "We are dedicated to providing clinicians and patients with an affordable, accessible, and highly sensitive diagnostic solution that enables timely and accurate decision-making."

Powering this breakthrough is Spear Bio's proprietary Successive Proximity Extension Amplification Reaction (SPEAR) technology. It employs a unique 2-factor authentication mechanism to minimize background from non-specific interactions, enabling accurate measurements of protein biomarkers at concentrations as low as 1 fg/mL from just 1 microliter of diluted sample. Its wash-free format allows free antigen-antibody interactions in a homogeneous solution, maximizing binding specificity.

The FDA Breakthrough Device Designation reinforces Spear Bio's next-generation approach to measuring protein biomarkers at exceptionally low concentrations. This highlights the ability of SPEAR Technology to meet the rigorous demands of neurodegenerative disease research and diagnostics, as well as improve patient management.