Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 289

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 289
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DT are
often the same as the uses of FDA-cleared or approved in vitro diagnostic tests, some labs may choose to offer their own test. For example,
a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market.”

While DiamiR’s plan is to validate the CogniMIR ®miRNA panel in its lab, DiamiR is also studying the feasibility of offering protein biomarker testing, including but not limited to, pTau-181, pTau-217, Neurofilament Light (NfL), Ab42/40 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-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.

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