Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 299

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 299
---
98ac-d790384f4ec2/alzheimers-facts-and-figures-special-report.pdf). 183 The survey also highlighted reasons for seeking an early stage AD diagnosis: Initial focus Since DiamiR’s 24-microRNA panel 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-run Ct 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-run analysis, each graph consisted of n = 192 Ct data points (4 samples × 24 miRNAs × 2 replicates). For each operator, the Cts from the first replicates were plotted against the Cts from the second replicates for Day 1 and Day 2. The R2 values were plotted against the Cts from the second replicates for Day 1 and Day 2. The R2 values between Replicate 1 and Replicate 2 on Day 1 and Day 2 for Operator 1 were 0.99 and 0.94. Similarly, the R2 values between Replicate 1 and Replicate 2 on Day 1 and Day 2 for operator 1 were .99 and .94, respectively. The R2 values between Replicate 1 and Replicate 2 on Day 1 and Day 2 for Operator 2 were both 0.95. The intra-run Ct correlation between the two replicates for the two operators on both days was R2 = 0.