Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 157

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 157
---
 for
their own use. Then, in 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA). These gave clinical laboratories
the ability to develop and perform their own tests to fill gaps in available testing and provided the framework for LDT regulation. Today,
all laboratories must have appropriate CLIA accreditation, overseen by the Centers for Medicare and Medicaid Services (CMS), to perform
LDTs. The regulatory agency oversees around 320,000 entities.

Historically, the FDA has
exercised enforcement discretion for LDTs, allowing labs to offer tests with little input from the agency. On May 6, 2024, FDA released
its long-awaited update to its LDT policy in the Federal Register. Under these new guidelines, the FDA will phase out enforcement discretion
in 5 stages over 4 years allowing labs to adjust to these new requirements in a timely and orderly manner. While grandfathering marketed
LDTs and creating a few other exceptions, the FDA will require all new LDTs to be launched according to its new guidelines.

On March 31, 2025, a Federal
Judge struck down FDA’s final rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food,
Drug, and Cosmetic Act (FDCA). The court ruled that the FDA lacked the statutory authority to classify LDTs—diagnostic tests
developed and used within a single laboratory—as medical devices, emphasizing that LDTs are professional medical services, not
tangible products subject to FDA regulation. This decision halts the FDA’s plan to phase out its general enforcement discretion over
LDTs, which would have introduced new compliance obligations over a four-year period. The court’s ruling underscores that oversight
of LDTs falls under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services
(CMS), not the FDA.

<div align='center'>74</div>

The FDA announced in May 2025
that it will not appeal this decision. If the FDA changes its position on this appeal, and wins on appeal, risks associated with the new
landscape of LDTs include but are not limited to:

| ● | DiamiR’s inability to implement quality standards included in the new guidelines |
| ● | DiamiR’s inability to implement all FDA requirements for LDTs                    |
| ● | Backlog at the FDA for review of submission                                      |
| ● | Additional regulations being adopted by