Grail LLC announced that it secured US regulatory approval for a study of its Galleri multicancer early detection test in people enrolled in Medicare, a research project intended to see how well this product works in an older population.
More specifically, the Centers for Medicare and Medicaid Services (CMS) and US Food and Drug Administration (FDA) approved an Investigational Device Exemption study to determine whether the Galleri blood test can reduce late-stage cancer diagnoses for cancers that don’t have traditional screening approaches.
Getting FDA approval for this study is part of Grail’s ongoing work to try to secure the agency’s endorsement for Galleri, which can detect more than 50 types of cancer. The blood test, which has been sold in the US since 2021, is not currently FDA approved, but Grail is hoping that interim data from its study will help the test secure premarketing authorization from the FDA.
Receiving premarketing authorization — the most stringent process the FDA uses to evaluate the safety and effectiveness of a class III medical device — could qualify the blood test for coverage under Medicare. That means Medicare would pay for the Galleri test as well as related services, an important shift given that few health insurers have been willing to pay for the test, which has a list price of $949.
The study will track outcomes in as many as 50,000 Medicare beneficiaries who will receive annual Galleri tests alongside routine medical care compared with a matched group who will only receive usual care. Participants will include individuals from racial and ethnic minorities, and seniors from historically underserved communities. Overall, the company will assess whether the blood test can catch cancers earlier when they are less advanced and decrease the use of healthcare resources.
The current study will add to the existing data on Galleri from the NHS-Galleri trial and the PATHFINDER 2 Study, which also received Investigational Device Exemptions.
“We expect that the data collected from the Galleri-Medicare study will add to the growing body of evidence that [multicancer early detection] has the potential to change the future of cancer detection as we know it,” said Josh Ofman, MD, MSHS, Grail’s president, in a press release.
Kerry Dooley Young is a freelance journalist based in Washington, D.C., You can follow her on BlueSky.
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