FDA Gives Clearance for CSF Assays for Dementia Testing

Roche announced that the Food and Drug Administration (FDA) approved 2 new laboratory tests to measure 2 biomarkers: phosphorylated-tau (pTau181) and beta-amyloid (Abeta42) concentrations in cerebrospinal fluid (CSF). The tests, available commercially as Elecsys Phospho-Tau (181P) CSF and Elecsys β-Amyloid (1-42) CSF II), have been previously registered in 45 countries. Results from these tests can be used to calculate a pTau181/Abeta42 ratio value that may be helpful in the evaluation of individuals aged 55 and older at risk for dementia, including Alzheimer disease (AD). The Elecsys assays will be available on cobas modular analyzer systems. 

Data provided by Roche in their announcement indicate that the results from the Elecsys CSF assays were 90% concordant with results obtained through amyloid PET scan imaging tests. A number of other CSF and plasma biomarker tests for dementia have recently been approved for use in the United States. 

According to Thomas Schinecker, PhD, chief executive officer of Roche Diagnostics, “The Elecsys AD CSF assays have the potential to guide more people with suspected AD toward a diagnosis than ever before. As we are starting to see exciting results for new potential AD treatments, reliable tests that have been clinically validated will be critical in ensuring the right patients are identified and able to benefit from them.”