Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 283

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 283
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 Organ-enriched miRNAs as Biomarkers of Rett Syndrome), the microRNA panel effectively differentiated
study participants with Rett syndrome.

To develop a marketable RTT
diagnostic solution, DiamiR plans to offer both sequencing services (of the MECP2 gene) and its proprietary miRNA panel. DiamiR
is currently evaluating 3 party vendors to develop a custom NGS assay for Rett syndrome on a MiSeQ platform (Illumina).

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BEYOND BRAIN HEALTH: UNIVERSAL SCREENING TEST

DiamiR believes its core miRNA technology is robust
and applicable to early detection of disease pathology in different organs, not only in the brain, which enables a novel approach to screening
whereby a battery of screening tests relying on organ-enriched miRNAs detect the presence of pathology in a given organ; where the detection
of a pathology in an organ can result in more specific (and possibly expensive and or invasive) testing for a differential diagnosis of
the disease.

In a proof-of-concept study, miRNA pairs comprised
of select miRNAs enriched in the organs of the gastrointestinal (GI) and pulmonary systems effectively differentiated respective pathologies
of the GI (esophageal, gastric or colon cancers (stages I and II), and Crohn’s disease) and lung (pneumonia, asthma, and non-small
cell lung cancer (40% with stages I and II)) systems from age-matched controls and from each other with an overall accuracy of 90-96%.

The figure below summarizes the approach and principal
findings:

(Journal of Translational Medicine, 2013, 11:304)

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ANALYTICAL PLATFORM FOR PLASMA miRNA DETECTION

In 2023, DiamiR completed an analytical
validation of plasma miRNA detection in DiamiR CLIA laboratory. The platform is based on Qiagen’s LNA qPCR technology.

In this study, published
in a peer-reviewed publication and reported at several scientific meetings (below), DiamiR has demonstrated that the 24 miRNA biomarker
candidates comprising CogniMIR panel, as well as additional miRNAs showing promise as RTT biomarker candidates, can be
reliably and consistently detected in human plasma samples with the methods implemented at DiamiR CLIA laboratory. While stem-loop-based
TaqMan and locked