Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 316

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 316
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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 -runreproducibility 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 -diseasedsamples) •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 insurance companies, as tests that are not reimbursed most likely will not gain uptake in the marketplace. To garner coverage and have a test deemed medically necessary, payors will typically require additional studies, including Clinical Utility studies aimed at demonstrating how a test changes patients’ treatment and/or physician behavior. For example, a test with high clinical utility may prevent unnecessary surgeries or help physicians choose the right therapeutic regimen for or recommend an important lifestyle change to a patient, when absent that test, a different treatment course, with worse results would be adopted.

186 While DiamiR plans on conducting Clinical Utility studies for its CogniMIR ®, at this time DiamiR has no assurances that insurance companies will cover