Look for Drugs and Conditions

Representative image

Roche Alzheimer’s disease cerebrospinal fluid tests receive USFDA premarket notification clearance

Swiss pharmaceutical and diagnostic MNC Roche has recently announced that it has received premarket notification clearance from the United States Food and Drug Administration (USFDA) for its Alzheimer’s Disease beta-Amyloid and Phospho-Tau cerebrospinal fluid and tests marketed as Elecsys.

In a statement, the company said that the clearance received under Section 501(K), has the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid in the brain.

Noting that the present option of an amyloid positron emission tomography (PET) scan, which measures the build-up of abnormal beta-amyloid protein in the brain, can be used as an adjunct to clinical evaluation is limited owing to the high-cost limited availability and exposure to radioactivity, Roche said that the assays achieve 90% concordance with the Amyloid PET scan imaging.

Commenting on the development, CEO of Roche Diagnostics, Thomas Schinecker, said, “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.”

“The Elecsys AD CSF assays have the potential to guide more people with suspected Alzheimer’s disease towards a diagnosis than ever before,” he added.

“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” Mr Schinecker stressed.

It may be noted that an early and accurate diagnosis allows those facing Alzheimer's an opportunity to take steps to preserve cognitive function, make better care plans, be guided by their physicians and get involved in clinical research that may lead to new treatments.

Pointing out that disease-modifying therapies are likely to be most beneficial when used in the earliest stages of the disease, Roche said that early and accurate diagnosis will be even more essential to ensure that people with Alzheimer’s receive the right treatment at the right time.

The diagnostic tests, which are still in development, are already registered in 45 countries, and the company announced in July 2022 that USFDA has already granted Breakthrough Device Designation to its Elecsys Amyloid Plasma Panel.


0 Comments
Be first to post your comments

Post your comment

Related Articles

Ad 5