**FDA Grants Breakthrough Device Designation to Diadem’s AlzoSure® Predict Prognostic Blood Test for the Early Prediction of Alzheimer’s Disease**
**—First Prognostic Blood Test that Can Predict Likely Progression to Alzheimer’s Disease Up to Six Years in Advance—**
**—Clinical Studies Show AlzoSure® Predict Can Identify with High Accuracy Whether Individuals with Early Cognitive Impairment Will or Will Not Progress to Alzheimer’s Disease—**
**San Francisco, CA – January 18, 2022**
**The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for AlzoSure® Predict, Diadem’s blood-based biomarker prognostic assay designed to identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer’s disease up to six years before definitive symptoms are apparent integrative biomarker. These include the many downstream interactions of p53 with p-tau and 1-40/1-42 amyloid, as documented in over 400 papers that have investigated the scientific rationale for these biomarkers. ...**
**The company’s technology uses an analytical method that includes a proprietary and patented antibody developed by Diadem and designed to bind to U-p53AZ and its target sequences. U-p53AZ is a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD in multiple studies. ...** [end quote]
As we all know, Alzheimer’s Disease (AD) is a huge and growing burden on the Macro economy. AD is being actively investigated. It’s hard to diagnose AD for sure since many other problems can mimic the symptoms. If a person is showing cognitive impairment but a blood test can show they don’t have AD, the doctor can look for and potentially cure the root cause.
Researchers are actively investigating many blood components seen in AD but they are analyzed in specialized research lab machines that aren’t available to doctors. This new blood test machine got accelerated FDA approval because having it available widely to neurologists could be a game-changer.
If AD is diagnosed early, it’s possible that it could be treated. The drugs that are available don’t work well but others are being investigated. Once AD is advanced, the damage has already been done.
I’m interested to see that the new machine uses an antibody that binds to a variant of p53. The p53 protein is a natural anti-cancer protein which isn’t one of the proteins usually associated with AD. (Those are amyloid and tau.) Apparently, p53 interacts with amyloid and tau to create a new shape which the antibody can detect. Very clever to look for this since it has been associated with AD in many studies.
Diadem is preparing for rapid commercialization of its initial Alzheimer’s prognostic via a global launch in collaboration with strategic partners. It will be interesting to follow this story since the design, manufacturing and marketing of this machine will be critical to its widespread use and (hopefully) eventual profitability.