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.