Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 352

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 352
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 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 213 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 -statelaboratories that accept specimens from those states. For example, New York State requires a laboratory to hold a permit, which is issued after an on -siteinspection and approval of testing methodology, and has various requirements over and above CLIA. For development of DiamiR’s tests, DiamiR plans to partner with CLIA -certifiedlaboratories that are also licensed in all or almost all states, including New York. All DiamiR’s tests will be developed as laboratory -developedtests (LDTs). FDA The United States Food and Drug Administration, or FDA, regulates the sale and distribution in interstate commerce of medical devices under the Federal Food, Drug, and Cosmetic Act, or the FDCA, including in vitro diagnostic devices (IVDs), reagents and instruments used to perform diagnostic testing. Devices must undergo premarket review by FDA prior to commercialization unless the device is of a type exempted from such review by statute, regulation, or pursuant to FDA’s exercise of enforcement discretion. DiamiR cannot assure that CogniMIR ®and its future products will not require in the future FDA approvals outside of current guidelines for LDTs, or, in such an event, that such approval or clearance would be forthcoming. Regardless of the regulatory framework, DiamiR intends to conduct multiple clinical studies in support of the analytical and clinical validity claims of its diagnostic tests. These studies will continue after DiamiR’s tests are launched to accumulate additional data and further evaluate benefits for patients and to inform healthcare providers. The results of the clinical testing will be fully communicated to the medical and scientific communities. DiamiR plans on launching its products under Lab Developed Test (LDT) path to market under CLIA in accordance with the current FDA guidelines. For decades, the FDA considered a laboratory developed tests (LDTs) to be a test that is intended for clinical