Beckman Coulter Gets FDA Breakthrough Status for Alzheimer’s Blood Test

Beckman Coulter Diagnostics, a global leader in clinical diagnostics, announced the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter’s Access p-Tau217/ß-Amyloid 1-42 plasma ratio. This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer's disease.

“We are honoured to receive Breakthrough Device Designation from the US FDA for our p-Tau217/ß-Amyloid 1-42 assay, a significant step forward in addressing the urgent need for earlier and more accurate detection of Amyloid pathology, a hallmark of Alzheimer’s disease,” said Kathleen Orland, senior vice president, general manager, clinical chemistry and immunoassay for Beckman Coulter Diagnostics. “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.""

“Focusing on shortening the time it takes to bring innovative assays to clinicians and patients is a core tenet of Danaher Diagnostics,” said Paul Beresford, Neurology Franchise Head, Danaher Diagnostics. “This exciting announcement that Beckman Coulter’s Access p Tau217/ß-Amyloid 1-42 Plasma Ratio blood test received Breakthrough Device Designation from the FDA is another proof point demonstrating our progress in developing a portfolio of clinical diagnostics tests for neurodegenerative diseases, starting with Alzheimer’s disease. We believe that by taking such a disease-focused approach, Danaher Diagnostics and its operating companies are able to develop more innovative and patient-friendly clinical solutions.”

The Access p-Tau217/ß-Amyloid 1-42 plasma ratio blood test measures the ratio of phosphorylated tau protein (p-Tau217) to ß-Amyloid 1-42, two key biomarkers implicated in the neurodegenerative processes of Alzheimer’s disease. A blood-based IVD test that can quantify these biomarkers in plasma could provide a non-invasive, accessible, and earlier method of detecting Alzheimer’s-related pathology, potentially before clinical symptoms manifest. This capability is important for improving early diagnosis, enabling timely intervention, and stratifying patients for therapeutic trials, ultimately accelerating progress in Alzheimer’s research and treatment.

Orland continued, “Beyond the Access p-Tau217/ß-Amyloid 1-42 plasma ratio blood test, Beckman Coulter is committed to developing a full suite of next-generation neurodegenerative disease tests. The aging global population combined with emerging drug treatments is expected to create widespread demand for Alzheimer’s disease testing, which will require accurate, high-throughput assays. The proprietary technologies on the Beckman Coulter DxI 9000 Immunoassay Analyzer coupled with its novel Lumi-Phos PRO substrate has enabled development of precise, clinically relevant assays and shown capability to detect targeted neurological biomarkers on an automated, high-throughput platform.”

The FDA Breakthrough Device Designation programme expedites the development and review of medical devices offering significant advancements in treating or diagnosing life-threatening or debilitating diseases. It provides prioritized review, enhanced communication, and regulatory support to help manufacturers bring innovative devices to market more efficiently, ultimately benefiting patients and public health.

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years.

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