Roche AD biomarker test panel granted breakthrough device designation by FDA


On 19 July, Roche announced that the US Food and Drug Administration (FDA) had granted a Breakthrough Device Designation to its Elecsys Amyloid Plasma Panel. The Roche panel is the first blood-based biomarker test for Alzheimer’s disease to receive this designation from the FDA, which opens the door to accelerated discussions and priority review by the regulator.

The goal of the FDA Breakthrough Devices Program is to provide patients with timely access to these medical devices by speeding up their development, assessment, and review. Breakthrough Device Designation means that manufacturers can obtain regular feedback on device development, and receive prioritised review for future regulatory submissions. Roche has previously been granted this FDA designation for two diagnostic tests that can be used to analyse biomarkers for Alzheimer’s disease (AD) in cerebrospinal fluid samples, which are obtained using lumbar punctures of the spine.

Conversely, the Elecsys Amyloid Plasma Panel is designed to be used for analysis of plasma samples, obtained via a minimally-invasive blood draw. The test panel measures pTau181, a protein that accumulates in the early stages of AD, and APOE4, which is the most common genetic risk factor for AD. The FDA Breakthrough Device Designation is for the use of this blood test in the treatment of symptomatic patients being assessed for AD and other causes of cognitive decline.