FDA grants 510(k) clearance for CSF assays to aid early Alzheimer’s diagnosis

The FDA has granted 510(k) clearance to Roche for its Elecsys beta-amyloid CSF II and total-tau CSF assays, designed to aid in the diagnosis of adults aged 55 and older being evaluated for Alzheimer’s disease.

According to a press release from Roche, both assays can detect pathology in the early stages of AD, such as mild cognitive impairment, as changes in levels of amyloid beta and tau are two key biomarkers of the disease.

Elecsys AD CSF assays can be used with amyloid positron emission tomography and may provide a more affordable and accessible option to confirm presence of amyloid pathology in the brain, while offering detection of both amyloid and tau biomarkers from a single blood draw, without the need for radiation, the company said.

“Now is the time for health care professionals and institutions to prepare to meet the demand for diagnostic methods to streamline and accelerate the path to the right treatment, at the right time, for people with Alzheimer’s,” Brad Moore, president and CEO of Roche Diagnostics North America, said in the release. “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.”

While the Elecsys pTau181/Abeta42 ratio is currently available, Roche expects the new Elecsys tTau/Abeta42 ratio will be available in the last quarter of 2023.

Editor’s note: On Sept. 21, 2023, this article was corrected to indicate that the news refers to the 510(k) status. Healio regrets the error.