Company: PSTV
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047698
Chunk: 90

Company: PLUS THERAPEUTICS, INC.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 90
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 or withdrawal of regulatory approvals;

•suspension or termination of any of our ongoing clinical trials;

•refusal to permit the import or export of our product candidates;

•refusal to approve pending applications or supplements to approved applications that we submit;

•product seizure;

•injunctions; or

•imposition of civil or criminal penalties.

43 

The future regulatory processes that will be applicable to Laboratory Developed Tests (LDTs) are uncertain and may prevent us from obtaining required authorizations for the commercialization of our products and/or introduce additional costs associated with those products. 

Within the laboratory, most tests can be divided into two categories: in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). IVDs are commercially manufactured assays and make up the majority of clinical laboratory tests, such as those in a comprehensive metabolic panel (CMP) and a complete blood count (CBC). LDTs, on the other hand, are developed by individual laboratories and overseen by highly trained and qualified laboratory directors. We plan to offer an LDT in the U.S. beginning in 2025. 

In 1976, Congress passed the Medical Device Amendments to the FDCA. These amendments gave the FDA explicit authority to regulate medical devices. These included tests developed by manufacturers sold for commercial purposes to laboratories around the country. However, the amendments did not specifically include tests developed by laboratories 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. 

Historically, the FDA has exercised enforcement discretion for LDTs, allowing labs to offer tests with little input from the agency. However, on May 6, 2024, the FDA issued a final rule in which it announced it was phasing out its general enforcement discretion approach so that LDTs manufactured by a laboratory will generally fall under the same enforcement approach as medical devices.  If implemented, this phase out of enforcement discretion will take place over several years. 

Congress is also working on legislative language that would clarify the FDA’s authority with respect to LDTs – and if enacted, would potentially supersede the final rule. In this regard, the “Verifying Accurate Leading-edge IVCT Development Act,” or