Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 325

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 325
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ptomatic Alzheimer Disease.” Boustani
et. al., Clinical Therapeutics. Volume 44, Issue 11, November 2022, Pages 1449-1462. https://doi.org/10.1016/j.clinthera.2022.09.008

https://cevr.tuftsmedicalcenter.org/publications/valuing-alzheimer-disease-therapies-considering-costs-and-benefits-beyond-the-patient

“Early intervention in
Alzheimer’s disease: a health economic study of the effects of diagnostic timing” Barnett et al. BMC Neurology 2014, 14:101].

Regulations

Clinical Laboratory Improvement Amendments of 1988 and State Regulation

In the United States,
as a diagnostic service provider, DiamiR is required to hold certain federal and state licenses, certifications and permits to conduct
its business. As to federal certifications, in 1988, Congress passed the Clinical Laboratory Improvement Amendments, or CLIA, establishing
quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of
where the test was performed. All DiamiR’s tests will be validated and performed at its laboratory, which is CLIA certified and
additionally accredited by the College of American Pathologists, or CAP, a CLIA approved accrediting organization.

Under CLIA, a laboratory is
any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis,
prevention or treatment of disease, or the impairment of, or assessment of health. CLIA also requires that a laboratory holds a certificate
applicable to the type of work performed and complies with certain standards. CLIA further regulates virtually all clinical laboratories
by requiring they be certified by the federal government and comply with various operational, personnel, facilities administration, quality
and proficiency requirements intended to ensure that their clinical laboratory testing services are accurate, reliable and timely. Laboratories
must register and list their tests with CMS, the agency that oversees CLIA; are subject to survey and inspection every two years
to assess compliance with program standards; and may be subject to additional unannounced inspections.

State Laboratory Testing— Several
states require the licensure of out-of-state laboratories that accept specimens from those states. For example, New York State requires
a laboratory to hold a permit, which is issued after an on-site inspection and approval of testing methodology, and has various requirements
over and above CLIA. For development