Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer’s Blood Test

Beckman Coulter Diagnostics, a global leader in clinical diagnostics, has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Access p-Tau217/β-Amyloid 1-42 plasma ratio test. This innovative blood test is designed to help healthcare providers detect amyloid pathology, a key indicator of Alzheimer’s disease, in a non-invasive and accessible manner.

Alzheimer’s blood test FDA breakthrough

The Access p-Tau217/β-Amyloid 1-42 plasma ratio test measures two critical biomarkers, p-Tau217 and β-Amyloid 1-42, which are directly associated with neurodegenerative processes in Alzheimer’s disease. Traditional diagnostic methods, such as PET scans and spinal fluid analysis, can be costly and invasive. A blood-based test offers a more efficient, patient-friendly, and scalable alternative for early diagnosis, helping clinicians identify at-risk patients sooner and improving access to potential treatments. This advancement is a true Alzheimer’s blood test FDA breakthrough.

“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.

Supporting Alzheimer’s research and patient care

The growing aging population and the development of new Alzheimer’s treatments are expected to drive demand for high-precision diagnostic tests. Beckman Coulter is committed to meeting this need by developing next-generation neurodegenerative disease tests that integrate seamlessly into existing clinical workflows.

“By taking a disease-focused approach, Danaher Diagnostics and its operating companies are able to develop more innovative and patient-friendly clinical solutions,” said Paul Beresford, Neurology Franchise Head at Danaher Diagnostics.

The Access p-Tau217/β-Amyloid 1-42 plasma ratio test is powered by Beckman Coulter’s DxI 9000 Immunoassay Analyzer and Lumi-Phos PRO substrate technology, allowing for high-throughput testing with unmatched precision. This technology ensures that healthcare providers can rapidly detect neurological biomarkers, improving the efficiency and reliability of Alzheimer’s diagnostics.

FDA breakthrough designation accelerates innovation

The FDA Breakthrough Device Designation program expedites the development and review of medical devices that provide significant advancements in diagnosing or treating life-threatening diseases. It offers:

• Priority review and enhanced communication with the FDA

• Regulatory support to accelerate product availability

• A streamlined approval process to bring life-changing innovations to patients faster

With this designation, Beckman Coulter is well-positioned to fast-track the commercialization of its Alzheimer’s blood test, making early detection more accessible to patients worldwide.

A leader in clinical diagnostics

For over 80 years, Beckman Coulter has been at the forefront of clinical innovation, providing cutting-edge diagnostic solutions for hospitals, reference laboratories, and healthcare providers worldwide. As part of Danaher, Beckman Coulter continues to drive progress in healthcare technology, applying science and innovation to improve patient outcomes and advance medical diagnostics.

For more information, visit www.beckmancoulter.com.