Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 312

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 312
---
 There are a number of platform technologies (ELISA, Mass Spec, PCR) from various vendors that could be implemented in DiamiR’s lab. In 2023, DiamiR completed the analytical and clinical validation of its APOE Genotyping assay under CLIA guidelines. APOE4 is a known genetic risk factor for AD ( https://www.nia.nih.gov/health/genetics-and-family-history/alzheimers-disease-genetics-fact-sheet). As part of DiamiR’s bi-annual CLIA lab inspection, the supporting data for its APOE test were reviewed in June 2024 and passed all requirements for its CLIA license. As a result, DiamiR’s CLIA license is now valid until June 2026.

<div align='center'>178</div>

The totality of DiamiR’s
analytical validation work demonstrated the performance characteristics of the test method to ensure its accuracy, precision, Limit of
Detection, and reliability under CLIA guidelines, before it is used for clinical diagnosis or research purposes.

APOEGenotyping
test was validated and carried out at DiamiR’s lab by using the TaqMan assays for two SNP locations on the APOE gene,
to detect the presence of either APOE alleles (E2/E2, E2/E3, E2/E4, E3/E3, E3/E4 and E4/E4) in the samples. A total of
10 pre-identified samples were utilized in this validation study to determine precision, lower limit of detection (LOD), and accuracy
analysis of the APOE Genotyping test. Evaluation of precision was done by assessing the repeatability (within-run), and
reproducibility (multiple runs within the lab) of the generated results. Two different results (raw Ct data and APOE Genotype
calls) were analyzed for the test validation. Both results were found to be reproducible, repeatable, and accurate in all the experimental
settings, which demonstrated that the DiamiR lab developed APOE Genotyping test is accurate in detecting APOE genotypes
of a patient. This was further confirmed by a 100% accuracy measurement of the APOE Genotyping test carried out in the
lab. Furthermore, DiamiR’s APOE Genotyping test is highly robust as reproducible and accurate APOE genotypes
were obtained successfully in wide range of DNA concentrations (0.7ng-50ng