Biotech Values

[DewDiligence]

Re: Blood test for assessing trajectory of Alzheimer’s progression

https://www.prnewswire.com/news-releases/diadem-presents-data-at-2023-aaic-showing-its-alzosure-blood-test-can-identify-patients-at-high-risk-of-significant-cognitive-decline-due-to-alzheimers-disease-301880532.html

Diadem SpA, a [private] company developing the first blood-based test for the early prediction of clinical progression to Alzheimer's disease (AD), today announced that study data being presented at the Alzheimer's Association International Conference 2023 (AAIC) further strengthens the evidence supporting the prognostic value of Diadem's AlzoSure Predict blood-based biomarker test… The study data are included in a scientific poster that is being presented today at AAIC 2023.

…in identifying whether or not an individual was a rapid progressor who would cognitively decline to AD within 2 years [AlzoSure Predict had] a positive predictive value/negative predictive value (PPV/NPV) of greater than 90% and specificity of greater than 95%.

… AlzoSure Predict is a non-invasive biomarker blood test that uses a proprietary antibody (U-p53AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure Predict's Breakthrough Device designation from the U.S. Food & Drug Administration.

…"We expect to launch AlzoSure Predict in the U.S. within the next 12 months in partnership with a major diagnostics firm and look forward to working with healthcare decision-makers to ensure it is widely accessible to patients and their families."

The FDA Breakthrough Device designation means that this is a serious endeavor, although plenty of competition is surely coming.