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Roche Alzheimer's Disease Assays Obtain FDA 510(k) Clearance

NEW YORK – Roche announced on Thursday that two of its tests for Alzheimer's disease have received 510(k) clearance from the US Food and Drug Administration.

The Elecsys Beta-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF assays measure two biomarkers that are "hallmarks" for Alzheimer's disease, beta-amyloid and tau proteins, in patients 55 and older who are being evaluated for the disease and other causes of cognitive impairment, Roche said in a statement. 

The cerebrospinal fluid-based tests run on the Cobas fully automated immunoassay analyzer. The assays have also achieved 90 percent concordance with amyloid positron emission tomography scan imaging, one of the standard diagnosis tools for Alzheimer's, Roche said. 

The assays have received CE marking and are registered in 45 countries globally, the firm added. The tests are intended to be used in addition to other clinical diagnostic evaluations, it noted. 

"The Elecsys AD CSF assays have the potential to guide more people with suspected Alzheimer's disease towards a diagnosis than ever before," Roche Diagnostics CEO Thomas Schinecker said in a statement. "As we are starting to see exciting results for new potential Alzheimer's treatments, reliable tests that have been clinically validated will be critical in ensuring the right patients are identified and able to benefit from them."