Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 268

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 268
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 Proof-of-Concept                                                                                                                              
 Study. In this phase, potential target analytes are identified and a plan for their detection is developed. In DiamiR’s case, DiamiR          
 focuses on miRNAs, and through literature searches and its own accumulated knowledge base identifies target miRNAs for a specific indication. 
 Once the target list is finalized, DiamiR checks the feasibility of testing for the expression of the target miRNAs and use synthetic         
 controls to develop a working assay.                                                                                                          |

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| Step 2: | Analytical                                                                                                                      
 Validation Study. In this step DiamiR’s goal is to determine key analytical validation metrics, as required by CLIA guidelines, 
 for the pipeline product. Using synthetic controls and/or call lines and clinical samples DiamiR establishes:                   |

| ● | Accuracy |

| ● | Precision |

| ● | Reproducibility; and |

| ● | Reportable ranges for the assay. |

DiamiR will also run the assay by multiple operators over different days to establish the test’s inter and intra-run reproducibility metrics. Test optimization refers to finalizing the testing parameters and locking in the Standard Operating Procedures (SOPs) and finalizing algorithms used to analyze the raw data from DiamiR’s runs.

| Step 3: | Clinical                                                                                                                              
 Validation Study. In this step, the tests’ performance characteristics will be determined using clinical samples with known outcomes. 
 By comparing DiamiR’s test results with clinical outcomes, DiamiR determined the assays:                                              |

| ● | Clinical 
 Accuracy |

| ● | Area Under the Curve (AUC, a measure of difference between 
 diseased and non-diseased samples)                         |

| ● | Sensitivity (a measure of Test’s ability to designate 
 an individual with disease as positive)               |

| ● | Specificity (a measure of Test’s ability to designate  
 an individual who does not have a disease as negative) |

| ● | Negative Predictive Value (NPV) |

| ● | Positive Predictive Value (PPV) |

A test with robust Clinical Validation results can be made commercially available. Once a test has successfully completed all three steps noted above, it can be commercialized. However, a producer/manufacturer may decide not to move to commercialize the test until it receives sufficient reimbursement coverage. Validating a test to ensure it is ready for launch requires clinical evidence and FDA clearance; commercializing a product requires reimbursement from CMS/Medicare and private