Roche Bags Fast Track Label for New Alzheimer’s Diagnostic

by Fujie Tham
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Swiss multinational Roche just received FDA Breakthrough Device Designation for its Elecsys Amyloid Plasma Panel, making it the first in-vitro panel to receive such a label. The minimally invasive test is designed to look for and quantify biomarkers of Alzheimer’s disease from blood samples, allowing the disease to be detected earlier.

Earlier in May, FDA approved the first in-vitro Alzheimer’s diagnostic, made by Fujirebio Diagnostics. Fujirebio’s in-vitro assay measures amyloid plaque concentration in the cerebral spinal fluid (CSF), however, Roche’s test will no doubt improve patients’ accessibility by just requiring blood plasma samples.

Alzheimer’s disease (AD) is the most common neurodegenerative disease with more than 50 million cases reported worldwide, characterized by the aggregation of beta-amyloid proteins in the brain, abnormal levels of this naturally occurring protein clump together to form plaques that disrupt brain cell function. Traditionally, AD is diagnosed using cognitive assessments, PET scans, or cerebrospinal fluid (CSF) tests.

Related article: Eisai and Biogen’s New Alzheimer’s Drug to Receive FDA Decision by January 


75% of People With Alzheimer’s Symptoms Go Undiagnosed


The Elecsys Amyloid Plasma Panel checks for phosphorylated Tau (pTau) 181 protein and apolipoprotein (APOE) E4 in patients’ plasma, a spike in pTau level usually occurs in early AD stages, while the presence of APOE E4 represents the genetic risk factor for the disease. If a patient is tested positive, further confirmation by PET scan or cerebrospinal fluid assay can be done. Besides this plasma-based diagnostic, Roche’s cerebrospinal fluid-based in vitro immunoassays also received FDA’s breakthrough designation previously.

“Key to transforming the life of people with Alzheimer’s disease is to diagnose as early as possible and intervene with the right care plans,” said Thomas Schinecker, Roche Diagnostics’ CEO.

In AD therapeutics, Roche and Eli Lilly are among the top competitors in the field with candidates that aim to neutralize amyloid-beta aggregates to slow down AD’s progression. Gantenerumab, one of Roche subsidiary Genentech’s candidates, has been in the works for several years. The company recently announced that it would begin a four-year Phase 3 clinical trial to study the safety and efficacy of Gantenerumab.


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