Beckman Coulter Achieves FDA Breakthrough Device Status for Alzheimer's Test
Beckman Coulter Diagnostics, a prominent name in clinical diagnostics, has made significant strides in Alzheimer's disease research by receiving the prestigious Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation was bestowed upon their innovative Access p-Tau217/β-Amyloid 1-42 plasma ratio test, designed to assist healthcare providers in identifying patients with amyloid-related pathology associated with Alzheimer's disease.
Kathleen Orland, Senior Vice President and General Manager of Clinical Chemistry and Immunoassay at Beckman Coulter, expressed pride in achieving this designation, highlighting the urgent need for improved detection methods. The test aims to enhance early diagnosis, allowing for timely intervention which could significantly improve patient care and management. This breakthrough underscores the potential of the Access p-Tau217/β-Amyloid 1-42 test to fundamentally change how Alzheimer's is diagnosed, leading to better outcomes for patients and their families.
In a statement, Paul Beresford, the Neurology Franchise Head at Danaher Diagnostics, emphasized the importance of innovation in clinical diagnostics. He noted that receiving the Breakthrough Device Designation reflects their commitment to focusing on neurological diseases, starting with Alzheimer's. This approach allows Beckman Coulter and Danaher to develop innovative and patient-friendly solutions that meet the critical demands of this area of healthcare.
The Access p-Tau217/β-Amyloid 1-42 plasma ratio test works by measuring the ratio of phosphorylated tau protein (p-Tau217) to β-Amyloid 1-42, both of which are key indicators in the neurodegenerative processes implicated in Alzheimer's disease. A blood-based In Vitro Diagnostic (IVD) test that quantifies these biomarkers could revolutionize the detection of Alzheimer's-related issues, providing a non-invasive and accessible diagnostic option. Early detection is vital, not only for improving future treatment outcomes but also for patient stratification in therapeutic trials, thereby facilitating advancements in Alzheimer's research.
Beyond this specific assay, Beckman Coulter is dedicated to expanding its capabilities within neurodegenerative disease diagnostics. With a rising aging population and new drug therapies on the horizon, the demand for accurate Alzheimer's testing is expected to grow. The company is poised to meet this demand with its advanced diagnostic technologies, embodied in the Beckman Coulter DxI 9000 Immunoassay Analyzer and the Lumi-Phos PRO substrate.
The FDA's Breakthrough Device Designation program is designed to expedite the development of medical devices that provide significant improvements in the treatment or diagnosis of life-threatening or debilitating conditions. This means that manufacturers of such devices receive prioritized review, enhanced communication, and overall regulatory support to expedite their products to market. Such support ultimately benefits public health by ensuring that useful and life-saving innovations reach patients faster.
Beckman Coulter has been an innovator in advanced diagnostics for over 80 years. With a mission entrenched in reimagining healthcare, the company is committed to leveraging science and technology to enhance patient health outcomes. Their solutions are globally utilized across hospitals, laboratories, and other medical settings. Beckman Coulter continues to strive toward accelerating patient care and providing efficient diagnostic solutions, reflecting their ongoing commitment to healthcare improvement. Their headquarters are based in Brea, California, where more than 11,000 employees work towards advancing healthcare diagnostics globally.
Kathleen Orland, Senior Vice President and General Manager of Clinical Chemistry and Immunoassay at Beckman Coulter, expressed pride in achieving this designation, highlighting the urgent need for improved detection methods. The test aims to enhance early diagnosis, allowing for timely intervention which could significantly improve patient care and management. This breakthrough underscores the potential of the Access p-Tau217/β-Amyloid 1-42 test to fundamentally change how Alzheimer's is diagnosed, leading to better outcomes for patients and their families.
In a statement, Paul Beresford, the Neurology Franchise Head at Danaher Diagnostics, emphasized the importance of innovation in clinical diagnostics. He noted that receiving the Breakthrough Device Designation reflects their commitment to focusing on neurological diseases, starting with Alzheimer's. This approach allows Beckman Coulter and Danaher to develop innovative and patient-friendly solutions that meet the critical demands of this area of healthcare.
The Access p-Tau217/β-Amyloid 1-42 plasma ratio test works by measuring the ratio of phosphorylated tau protein (p-Tau217) to β-Amyloid 1-42, both of which are key indicators in the neurodegenerative processes implicated in Alzheimer's disease. A blood-based In Vitro Diagnostic (IVD) test that quantifies these biomarkers could revolutionize the detection of Alzheimer's-related issues, providing a non-invasive and accessible diagnostic option. Early detection is vital, not only for improving future treatment outcomes but also for patient stratification in therapeutic trials, thereby facilitating advancements in Alzheimer's research.
Beyond this specific assay, Beckman Coulter is dedicated to expanding its capabilities within neurodegenerative disease diagnostics. With a rising aging population and new drug therapies on the horizon, the demand for accurate Alzheimer's testing is expected to grow. The company is poised to meet this demand with its advanced diagnostic technologies, embodied in the Beckman Coulter DxI 9000 Immunoassay Analyzer and the Lumi-Phos PRO substrate.
The FDA's Breakthrough Device Designation program is designed to expedite the development of medical devices that provide significant improvements in the treatment or diagnosis of life-threatening or debilitating conditions. This means that manufacturers of such devices receive prioritized review, enhanced communication, and overall regulatory support to expedite their products to market. Such support ultimately benefits public health by ensuring that useful and life-saving innovations reach patients faster.
Beckman Coulter has been an innovator in advanced diagnostics for over 80 years. With a mission entrenched in reimagining healthcare, the company is committed to leveraging science and technology to enhance patient health outcomes. Their solutions are globally utilized across hospitals, laboratories, and other medical settings. Beckman Coulter continues to strive toward accelerating patient care and providing efficient diagnostic solutions, reflecting their ongoing commitment to healthcare improvement. Their headquarters are based in Brea, California, where more than 11,000 employees work towards advancing healthcare diagnostics globally.
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