Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 302

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 302
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; 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 of DiamiR’s tests, DiamiR plans to partner with CLIA-certified laboratories that are also licensed
in all or almost all states, including New York. All DiamiR’s tests will be developed as laboratory-developed tests (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.

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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 use and that is developed, validated, and performed within a single laboratory
that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA
to perform high complexity testing. The FDA has historically asserted its authority to regulate LDTs as medical devices under the FDCA,
but it has generally exercised enforcement discretion with regard to LDTs. This means that even though