Spear Bio Secures FDA Breakthrough Device Designation for its Novel pTau 217 Blood Test, Advancing Scalable Solutions for Early Alzheimer’s Disease Diagnosis | PR Newswire [Video]

, /PRNewswire/ — Spear Bio Inc., a biotechnology company pioneering next-generation ultra-sensitive immunoassays, today 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 …