The U.S. Food and Drug Administration (FDA) recently approved a new blood test that could be the future of cancer screening. This biomarker, known as the Lumipulse G Beta-Amyloid Ratio (1-42/1-40), was created by Fujirebio Diagnostics. Together with our partners, this test represents a significant advance in the effort to help diagnose Alzheimer’s disease earlier. Today, nearly 7 million Americans are living with this debilitating condition, and projections indicate that figure may double to nearly 13 million by 2050.
The Lumipulse test measures the concentration ratio of Beta-amyloid 42 to 40 proteins in human cerebral spinal fluid (CSF). Most notably, it has achieved astounding specificity in the prediction of amyloid pathology related to Alzheimer’s. In both clinical and analytical evaluations, the test produced indeterminate results in less than 20% of patients tested. Additionally, 91.7% of participants that received positive results from the Lumipulse test provided evidence of amyloid plaques. This was corroborated by either a PET scan or a CSF analysis indicating the presence of amyloid pathology. In contrast, 97.3% of those who tested negative were found to have a negative amyloid PET scan or CSF test result.
FDA Commissioner Martin A. Makary, MD, MPH, highlighted the significance of this development, stating, “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined.” He further added, “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
In 2022, the FDA granted market authorization to the Lumipulse G Beta-Amyloid Ratio. Approval of this diagnostic tool continues FDA’s efforts to expand diagnostic capabilities for Alzheimer’s disease. By speeding up the diagnosis process, the hope is this new test will enable quicker intervention, leading to better patient outcomes.
Michelle Tarver, MD, PhD, emphasized the importance of the Lumipulse test in addressing the growing challenges posed by Alzheimer’s disease. “These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired,” she remarked. Tarver noted that the introduction of such medical products marks “an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease.”
Leave a Reply