Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Thursday, April 25, 2024

FDA grants breakthrough device designation to blood-based Alzheimer’s biomarker assay

 You likely want this because of your risk of dementia post stroke, that way your doctor can implement those EXACT DEMENTIA PREVENTION PROTOCOLS that don't exist because of your doctor's incompetence!

Your risk of dementia, has your doctor told you of this?  Your doctor is responsible for preventing this!

1. A documented 33% dementia chance post-stroke from an Australian study?   May 2012.

2. Then this study came out and seems to have a range from 17-66%. December 2013.`    

3. A 20% chance in this research.   July 2013.

4. Dementia Risk Doubled in Patients Following Stroke September 2018 


The latest here:

FDA grants breakthrough device designation to blood-based Alzheimer’s biomarker assay

Key takeaways:

  • The in vitro immunoassay is being developed by Roche in partnership with Eli Lilly & Co.
  • Blood-based biomarker assays aid health care providers in more rapidly identifying amyloid pathology.

The FDA has granted breakthrough device designation to a blood-based biomarker test to more quickly detect amyloid presence in individuals with suspected Alzheimer’s disease, according to the manufacturer.

In a press release, Roche said its Elecsys phospho-tau 217 assay, which is being developed in collaboration with Eli Lilly & Co., is intended to be an in vitro diagnostic immunoassay to quantitatively determine presence of the disease-specific protein taken in human plasma from individuals aged 60 years and older.

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The FDA granted breakthrough device designation to a blood-based biomarker assay intended for rapid detection of Alzheimer’s-related tau pathology. Image: Adobe Stock

“We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease, a condition where Roche Diagnostics is committed to improving the lives of patients worldwide,” Roche Diagnostics CEO Matt Sause said in the release.

A phosphorylated fragment of the protein tau, p-tau 217 has previously demonstrated the ability in research settings to distinguish AD from other neurodegenerative disorders, along with strong performance relative to other biomarkers, per the release.

Breakthrough designation for Roche’s assay comes just over a month after the FDA granted the same status for a similar p-tau 217 biomarker assay from Quanterix.

“Blood-based tests for Alzheimer’s can be run inexpensively and at scale in large populations,” Brad Moore, president and CEO of Roche Diagnostics North America, told Healio in an email. “Roche is working to ensure worldwide access to timely Alzheimer’s diagnosis for patients and [health care providers].”

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