FDA/CDC

FDA clears new biomarker assays for early Alzheimer’s detection


 

Roche has received Food and Drug Administration 510(k) clearance for additional cerebrospinal fluid (CSF) assays for Alzheimer’s disease (AD), supporting timely diagnosis and treatment decision-making.

The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.

They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022.

A stamp saying "FDA approved." Olivier Le Moal/Getty Images

“An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.

Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.

“The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain,” Roche said.

“They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease,” the company added.

The previously approved Elecsys pTau181/Abeta42 ratio is currently available and the newly approved Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.

A version of this article first appeared on Medscape.com.

Recommended Reading

Blood biomarker may help predict who will develop Alzheimer’s
MDedge Internal Medicine
Muscle fat: A new risk factor for cognitive decline?
MDedge Internal Medicine
Cognitive decline risk in adult childhood cancer survivors
MDedge Internal Medicine
FDA panel unanimously endorses lecanemab for Alzheimer’s
MDedge Internal Medicine
Daily multivitamins boost memory in older adults: A randomized trial
MDedge Internal Medicine
Are periodontitis, stroke, and Alzheimer’s disease linked?
MDedge Internal Medicine
Altered gut bacteria a biomarker of preclinical Alzheimer’s?
MDedge Internal Medicine
No link between PPIs and dementia in new study
MDedge Internal Medicine
Regular napping linked to greater brain volume
MDedge Internal Medicine
No link between heartburn meds and dementia
MDedge Internal Medicine