Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 301

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 301
---
2129392. Published online 2021 Oct.22. doi: 10.1001/jamanetworkopen.2021.29392PMCID: PMC8536950. PMID: 34677596

“Assessing the Cost-effectiveness of a Hypothetical
Disease-modifying Therapy With Limited Duration for the Treatment of Early Symptomatic 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