A new blood test designed to detect Alzheimer's disease pathology received Breakthrough Device Designation from the US Food and Drug Administration, Beckman Coulter Diagnostics announced in a press release. The test measures the ratio of two key biomarkers: phosphorylated tau protein (p-Tau217) and β-Amyloid 1-42 in plasma.
The diagnostic tool, known as the Access p-Tau217/β-Amyloid 1-42 plasma ratio, aims to provide a less invasive method for identifying amyloid pathology, a characteristic hallmark of Alzheimer's disease. This development could significantly alter current diagnostic approaches, which often rely on more invasive or costly procedures.
"This designation reflects the potential of our test to transform how Alzheimer's disease is diagnosed and managed, ultimately leading to improved outcomes for patients and families affected by this devastating disease," said Kathleen Orland, senior vice president and general manager of clinical chemistry and immunoassay at Beckman Coulter Diagnostics in a press release.
With an aging global population and emerging drug treatments, the demand for accessible diagnostic tools is expected to increase. The test is designed to run on the DxI 9000 Immunoassay Analyzer platform, utilizing the company's Lumi-Phos PRO substrate technology to detect neurological biomarkers.
The technology's potential advantages include:
- Non-invasive sample collection through standard blood draw
- Earlier detection of Alzheimer's-related pathology
- Improved accessibility to diagnostic testing
- Potential for high-throughput screening
- Application in therapeutic trial stratification
Paul Beresford, neurology franchise head at Danaher Diagnostics, emphasized the importance of rapid innovation in this field, stating in the press release, "Focusing on shortening the time it takes to bring innovative assays to clinicians and patients is a core tenet of Danaher Diagnostics."
The company indicates this blood test is part of a broader initiative to develop additional neurodegenerative disease diagnostics, though a specific timeline for market availability was not disclosed.
SOURCE: Beckman Coulter Diagnostics
