Roche Granted FDA Clearance for Additional Alzheimer's Disease Cerebrospinal Fluid (CSF) Assays, Enabling Timely Diagnosis and Treatment Decision-Making

Wednesday, June 28, 2023

Roche, a pharmaceutical company listed as RO and ROG on the SIX Swiss Exchange and RHHBY on the OTCQX, has announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) have received clearance from the U.S. Food and Drug Administration (FDA) through the 510(k) pathway. These assays are designed to measure beta-amyloid and tau proteins, which are biomarkers associated with Alzheimer's disease, in individuals aged 55 and older who are undergoing evaluation for the disease.

At present, diagnosing Alzheimer's disease typically involves ruling out other potential causes of symptoms through various assessments, including cognitive exams, laboratory tests, and neuroimaging. However, this process can be time-consuming and may not always yield an accurate diagnosis based on clinical criteria. Additional evaluations utilizing Alzheimer's-specific biomarkers can enhance medical decision-making by identifying early pathological changes associated with the disease.

Roche's newly cleared Alzheimer's tests in the United States include two ratios comprising three assays. Both ratios involve the measurement of Abeta42. The Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays, which received FDA 510(k) clearance in 2022, and the Elecsys beta-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF assays (the tTau/Abeta42 ratio) collectively cover the primary Alzheimer's pathologies, enabling clinicians to establish a more comprehensive biological definition of the disease and facilitate accurate diagnosis.

Obtaining an early and precise diagnosis is crucial for patients, caregivers, and physicians to determine appropriate treatment strategies. The Elecsys CSF assays support early-stage disease diagnosis, when interventions are most effective. Furthermore, these assays have demonstrated concordance with amyloid PET scan imaging, providing a potentially more accessible and cost-effective option for confirming the presence of amyloid pathology in the brain. Unlike PET scans, which require multiple appointments and expose patients to radiation, the Elecsys CSF assays can detect Alzheimer's biomarkers from a single sample, offering a less invasive alternative.

Roche has also announced that the FDA has granted Breakthrough Device Designation to its Elecsys Amyloid Plasma Panel, an innovative solution that allows for the measurement of Alzheimer's biomarkers from a blood sample. Although still in development, this panel has the potential to streamline the confirmation of amyloid pathology using the Elecsys CSF assays once it becomes available.


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