Spear Bio Inc. and Beckman Coulter Diagnostics have both received Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for their respective blood tests aimed at improving the early diagnosis of Alzheimer's disease. These designations highlight the potential of these tests to address the urgent need for more accessible and less invasive diagnostic methods for the millions of Americans living with undiagnosed Alzheimer's.
Spear Bio's pTau 217 Blood Test
Spear Bio's pTau 217 plasma assay is designed to measure levels of pTau 217, a key biomarker for Alzheimer's disease, in plasma. The test utilizes Spear Bio's proprietary Successive Proximity Extension Amplification Reaction (SPEAR) technology, enabling accurate measurements of protein biomarkers at concentrations as low as 1 fg/mL from just 1 microliter of diluted sample. This technology employs a 2-factor authentication mechanism to minimize background noise, maximizing binding specificity in a wash-free format. According to Feng Xuan, PhD, Co-Founder & CEO of Spear Bio, this designation marks an important milestone, reflecting the company's dedication to providing clinicians and patients with an affordable, accessible, and highly sensitive diagnostic solution.
The pTau 217 blood test is intended to aid in the diagnosis of Alzheimer's disease and distinguish it from other neurological conditions. Current diagnostic methods, such as PET scans and lumbar puncture cerebrospinal fluid (CSF) analysis, are invasive, costly, and logistically challenging. The new assay offers a convenient, accessible, and less invasive alternative for identifying or dismissing the presence of amyloid pathology, empowering clinicians to diagnose Alzheimer's disease earlier and more efficiently.
Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 Plasma Ratio
Beckman Coulter Diagnostics' Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test measures the ratio of phosphorylated tau protein (p-Tau217) to β-Amyloid 1-42, both key biomarkers implicated in Alzheimer's disease. This blood-based IVD test aims to provide a non-invasive and earlier method of detecting Alzheimer's-related pathology. Kathleen Orland, Senior Vice President, General Manager, Clinical Chemistry and Immunoassay for Beckman Coulter Diagnostics, stated that the designation reflects the potential of their test to transform how Alzheimer's disease is diagnosed and managed, ultimately leading to improved outcomes for patients and families affected by the disease.
Beckman Coulter is committed to developing a full suite of next-generation neurodegenerative disease tests, leveraging proprietary technologies on the Beckman Coulter DxI 9000 Immunoassay Analyzer coupled with its novel Lumi-Phos PRO substrate. These technologies enable the development of precise, clinically relevant assays capable of detecting targeted neurological biomarkers on an automated, high-throughput platform.
Impact of Breakthrough Device Designation
The FDA's Breakthrough Device Designation program is designed to expedite the development and review of medical devices that offer significant advancements in treating or diagnosing life-threatening or debilitating diseases. This designation provides prioritized review, enhanced communication, and regulatory support, helping manufacturers bring innovative devices to market more efficiently, ultimately benefiting patients and public health. With an aging global population and emerging drug treatments, the demand for accurate, high-throughput Alzheimer's disease testing is expected to increase, making these advancements crucial for improving patient care and accelerating progress in Alzheimer's research and treatment.
