Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 373

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 373
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 is also studying the feasibility of offering protein biomarker testing, including but not limited to, pTau -181, pTau -217, Neurofilament Light (NfL), A β42/40 and TDP43 in it lab. 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 -annualCLIA 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. 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 APOEgene, to detect the presence of either APOEalleles (E2/E2, E2/E3, E2/E4, E3/E3, E3/E4 and E4/E4) in the samples. A total of 10 pre -identifiedsamples were utilized in this validation study to determine precision, lower limit of detection (LOD), and accuracy analysis of the APOEGenotyping 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 APOEGenotype calls) were analyzed for the test validation. Both results 214 were found to be reproducible, repeatable, and accurate in all the experimental settings, which demonstrated that the DiamiR lab developed APOEGenotyping test is accurate in detecting APOE genotypes of a patient. This was further confirmed by a 100% accuracy measurement of the APOEGenotyping test carried out in the lab. Furthermore, DiamiR