Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 269

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 269
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, 5003-5008 (2011); Sun, et al., Clin. Chem.
Lab. Med. 50, 2121-2126 (2012)).

In October 2024, the
Nobel Assembly at Karolinska Institutet awarded the 2024 Nobel Prize in Physiology or Medicine jointly to Dr. Victor Ambros and Dr.
Gary Ruvkun for the discovery of microRNA and its role in post-transcriptional gene regulation. The press release regarding this
award stated that the recipients “groundbreaking discovery revealed a completely new principle of gene regulation that turned
out to be essential for multicellular organisms, including humans. It is now known that the human genome codes for over one thousand
microRNAs. Their surprising discovery revealed an entirely new dimension to gene regulation. MicroRNAs are proving to be
fundamentally important for how organisms develop and function.” (The Nobel Prize in Physiology or Medicine 2024 -
NobelPrize.org). Although Dr. Ambros and Dr. Ruvkun are not associated with DiamiR, their discovery laid the foundation for the
diagnostic approach developed by DiamiR team.

In vitro analysis of miRNAs as potential biomarkers

Investigators typically use one of two methods
to discover whether miRNAs correlate with a disease, and each method has its limitation: first, expression patterns of hundreds of miRNAs
in a bodily fluid from patients with a pathology of interest and from control subjects are compared using RT-qPCR, miRNA array or next
generation sequencing (NGS). NGS is a technology for DNA and RNA sequencing and variant/mutation detection. This technology combines
the advantages of unique sequencing chemistries, different sequencing matrices, and bioinformatics technology. Such a combination allows
a massive parallel sequencing of various lengths of DNA or RNA sequences or even whole genome within a relatively short period of time.
NGS involves several major steps in sequencing: DNA fragmentation, library preparation, parallel sequencing, and bioinformatics analysis,
and variant/mutation annotation and interpretation.

Second, analysis of disease-specific miRNAs is
performed by comparing miRNAs isolated from pathologic and normal tissue, organ, or cells (MicroRNA profiling: approaches and considerations.
Colin C. Pritchard et. al., Nature Reviews Genetics volume 13, pages 358–369 (2012)). Both approaches hold promise; however,
because the identified biomarkers are not restricted to a particular organ or tissue, they