Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 326

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 326
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 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.

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.

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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 the FDA believes it can
impose regulatory requirements on LDTs, such as requirements for premarket review, de novo classification, or clearance of LDTs,
it has generally chosen not to enforce those requirements. The FDA has, on occasion, sent warning letters to laboratories offering LDTs
that the agency believed were not eligible for enforcement discretion because of how they were