Galleri Filing Shows the Line Between Lab-Developed and FDA-Approved Tests

GRAIL said on January 29 that it had submitted the final module of its premarket approval (PMA) application to the Food and Drug Administration for Galleri, its blood test that looks for signals of many cancers at once. The company's announcement said the filing focuses on results from 25,490 participants in the US PATHFINDER 2 study with one year of follow-up, and on the first screening round of the NHS-Galleri trial in England, plus a bridging analysis comparing the versions used in those studies with the updated version submitted for approval. FDA gave the test breakthrough device designation in 2018, the company said.

Galleri is not new to the US market. GRAIL has been selling it for more than four years without FDA review, as a laboratory developed test. The filing shows where the line between the two kinds of test sits.

What a laboratory developed test is

In its quarterly report for the period ended September 30, 2025, GRAIL described laboratory developed tests, or LDTs, as in vitro diagnostic tests "intended for clinical use" that are designed, manufactured and used within a single laboratory certified for high-complexity testing under the Clinical Laboratory Improvement Amendments, known as CLIA. Galleri was launched as an LDT in mid-2021, and "FDA approval is currently not required to market our test in the United States," the company wrote.

FDA historically took the view that LDTs are medical devices but did not enforce certain requirements for them, including premarket review, a policy known as enforcement discretion, GRAIL's filing explains, with exceptions such as tests sold directly to consumers or tests used in public health emergencies.

The rule that was struck down

On May 6, 2024, FDA issued a final rule adding the words "including when the manufacturer of these products is a laboratory" to the regulatory definition of in vitro diagnostic products, according to FDA's page on laboratory developed tests. GRAIL's report said the rule would have phased out enforcement discretion over four years. On March 31, 2025, a federal district court vacated the rule, and on September 19, 2025, FDA issued a final rule reverting to the regulation's earlier text, the FDA page says.

GRAIL's filing said the court reasoned that LDTs are not medical devices subject to the Federal Food, Drug, and Cosmetic Act, and that the decision was not appealed. The company told investors it remains uncertain how the ruling affects FDA's authority to review marketing applications for LDTs, and that it might have to change its application or laboratory processes so that FDA can treat Galleri as a device.

Why seek approval anyway

GRAIL's report links its PMA plans to payment. Galleri is covered by some self-insured employers and health plans, including TRICARE, but the company said it lacks broader coverage from Medicare or large commercial insurers, and that it believes FDA approval "could unlock coverage from large commercial payors." The company also said it supports proposed legislation that would allow Medicare to cover FDA-approved multi-cancer early detection tests.

GRAIL has cautioned that PMA approval "can take several years from the time an application is submitted, if at all." Until FDA acts, Galleri remains on the market under the same LDT status it has had since 2021.