Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer ' s disease diagnosis

The Elecsys ® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and CompanyOnce approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer ’s diseaseRoche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer ’s diagnosisBasel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer ’s disease on people and society.“The incidence of dementia is growing worldwide, with 75 percent of cases remaining undiagnosed1. Consequently, there is a critical role for Diagnostics to play in addressing this global health challenge, ” said Matt Sause, CEO of Roche Diagnostics. “We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease, a condition where Roche Diagnostics is committ...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news