The team at Boston Healthcare have heard from diagnostic innovators seeking information on the Diagnostics Accuracy and Innovation Act (“DAIA”), with specific regard to recent advice provided by the US Food and Drug Administration (FDA). In August, the FDA responded to the draft legislation with formal comments, which included the addition of a precertification program that would exempt certain diagnostics from the premarket approval pathway.

The DAIA would eliminate the distinction between FDA-approved or cleared tests and laboratory developed tests. Instead, all tests would be designated as vitro clinical tests (IVCT), which will include both finished products (e.g., test kits and platforms) and laboratory test protocols (i.e., LDTs). IVCTs will be a new category and regulatory structure under the Food, Drug, and Cosmetic Act, and will not be regulated as devices, drugs, or biologics. Under the DAIA, laboratory operations will be regulated exclusively by the Centers for Medicare & Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA), while the FDA will evaluate tests for market entry.

The potential changes could allow existing tests to be grandfathered, avoiding additional regulatory hurdles for LDTs that are already on the market. Under the draft bill, IVCTs will require a report stating the test was developed and first introduced 90 days prior to enactment of the legislation and has not been reviewed by the FDA. However, if the test is modified in such a way that it becomes a new test, it will not be eligible for ‘grandfathering’ and will need to be reviewed according to the new regulatory processes that will be established.

The risk-level of each assay will drive the approval pathway for that test: each assay will be designated as low, medium, or high risk, based on its potential impact on patient care. Lower risk assays could be exempt from approval or be eligible for a precertification pathway, whereas higher-risk assays will likely need to move through the premarket approval pathway.

The draft bill also outlines specific criteria for tests for rare diseases, and custom and low volume tests.

Even though the legislation is still in draft form, the likelihood that the current regulatory regime will change is high, given the heightened FDA coordination with Congress.

Diagnostics innovators should consider the bill and its implications on commercialization strategies for products that are currently available and those that are in development.