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  • Roche Alzheimer's...

Roche Alzheimer's disease Cerebrospinal Fluid assays get USFDA clearance

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-12-11T12:00:22+05:30  |  Updated On 11 Dec 2022 12:00 PM IST
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu
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The Elecsys AD CSF assays achieve 90% concordance with the Amyloid PET scan imaging.

Basel: Roche has announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and pTau181 assays (used as a pTau181/Abeta42 ratio) measure two biomarkers that are hallmarks of Alzheimer's pathology, beta-amyloid, and tau proteins, in adults ages 55 and older being evaluated for the disease.

Currently, the diagnosis of Alzheimer's is a diagnosis of exclusion, largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan). Clinical criteria are currently limited and lead to an accurate diagnosis in only 70-80% of cases. To increase diagnosis accuracy, an amyloid positron emission tomography (PET) scan, that measures the build-up of abnormal beta-amyloid protein in the brain, can be used as an adjunct to these evaluations. However, the high cost, limited availability, and exposure to radioactivity limit its use. The Elecsys AD CSF assays achieve 90% concordance with the Amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid in the brain. They also offer the detection of multiple biomarkers from one draw, with no radiation and potential to detect Alzheimer's pathology in early stages of disease.

"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 process," said Thomas Schinecker, CEO of Roche Diagnostics. "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."

An early and accurate diagnosis allows those facing Alzheimer's, under the guidance of their physician, an opportunity to take steps to preserve cognitive function, make better care plans, and get involved in clinical research that may lead to new treatments. Research suggests that disease-modifying therapies are likely to be most beneficial when used in the earliest stages of the disease. Therefore, early and accurate diagnosis will be even more essential to ensure that people with Alzheimer's receive the right treatment, at the right time. Due to the large installed base of instruments, the Elecsys AD CSF assays are easily scalable to meet the imminent demand that these therapies will generate as they become available.

Roche's Elecsys AD CSF assays are already registered in 45 countries worldwide, including those accepting the CE Mark. In July, Roche also announced that the FDA granted Breakthrough Device Designation to its Elecsys Amyloid Plasma Panel, an innovative, minimally invasive and easily accessible solution which enables the measurement of Alzheimer's biomarkers from a blood sample. These assays are still in development but once they are available, they could be used to streamline patients toward confirmation of amyloid pathology using the Elecsys AD CSF assays.

Read also: Roche Gets CDSCO Panel Nod To study Ophthalmic Drug Faricimab

RocheRoche newsElecsys beta AmyloidElecsys Phospho TauUSFDAAlzheimers disease
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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