Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 346

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 346
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 million and is estimated to reach 88.5 million by 2050. Studies from Harvard and Tufts Medical Center establish a high level of interest in early detection of AD and report that 66%–70% of respondents would like to be screened for AD even if no treatment is available [Harvard study: Alzheimer’s Research & Therapy2013, 5:43; telephone survey of 2,678 respondents from the US, France, Germany, Poland, Spain; Tufts study: Health Econ2012, 21:238; internet survey of 1,463 US respondents]. The Special Report titled “American Perspectives on Early Detection of Alzheimer’s Disease in the Era of Treatment” published by the Alzheimer’s Association in the first half of 2025 states: “Nearly 4 in 5 Americans surveyed would want to know if they had Alzheimer’s disease before having symptoms, or before those symptoms interfered with their activities” ( https: // www.alz.org / getmedia / 3d226bf2-
0690 -48d0-98 ac-d 790384f4ec2 /alzheimers -facts - and-figures - special-report .pdf). 208 The survey also highlighted reasons for seeking an early stage AD diagnosis: Initial focus Since DiamiR’s 24 -microRNApanel for risk assessment of Alzheimer’s disease, CogniMIR ®is now analytically validated, DiamiR’s miRNA panel can be used to screen patients for MCI and AD clinical trials. In order to satisfy CLIA requirements, for analytical validation, DiamiR performed studies to demonstrate the assay’s performance characteristics, including: •Accuracy •Precision •Reportable range •Reference intervals/range The results of this validation work were published in Journal Diagnostics, in July 2023: “Analytical Validation of a Novel MicroRNA Panel for Risk Stratification of Cognitive Impairment”. Kunwar et.al, Diagnostics 2023,13, 2170. DiamiR believes its test can be launched as an LDT under current FDA guidelines. Should the FDA guidelines change in the future and require FDA approval of DiamiR’s CogniMIR ®test, it will increase the time, costs, resources and risk of the test launch. In this study, intra -runCt correlation between the replicates obtained from two days for two operators was determined by creating a scatterplot and identifying the R2 value. For the intra -runanalysis, each graph