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The best medtech innovations of 2023

October 30, 2023 By Jim Hammerand

2023’s best medtech innovations

Category: Best Medical Technology
Nominee: Roche Elecsys Beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (p-Tau181) assays

Roche’s Elecsys cerebrospinal fluid assays can detect biomarkers of Alzheimer’s disease. [Photo courtesy of Roche]

Roche won FDA 510(k) clearance for its Elecsys Beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (p-Tau181) cerebrospinal fluid assays in 2022. Used together, they measure two biomarkers of Alzheimer’s pathology — beta-amyloid and tau proteins — in adults ages 55 and older being evaluated for the disease.

“The abnormal phosphorylation of tau protein leads to formation of intracellular neurofibrillary tangles,” Roche says. “Together with the amyloid plaques, these modifications constitute the hallmark pathologies in [Alzheimer’s disease] and changes in these biomarkers were shown to occur before clinical symptoms.”

Roche Diagnostics said the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective.

“Globally, up to 75% of people living with Alzheimer’s disease have not been diagnosed, and those who have often report a long and complicated process5,” Roche Diagnostics CEO Thomas Schinecker said in a news release. “The Elecsys AD CSF assays have the potential to guide more people with suspected Alzheimer’s disease towards a diagnosis than ever before. 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.”

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