Grail Seeks FDA Green Light for Pioneering Multi-Cancer Blood Test, Paving Way for Broader Insurance Coverage
This analysis is based on reporting originally published by MedTech Dive.
In a pivotal move for the cancer diagnostics field, Grail announced it has filed for U.S. Food and Drug Administration (FDA) premarket approval (PMA) of its Galleri multi-cancer early detection (MCED) blood test. Securing FDA clearance is viewed as a crucial gateway to achieving broad coverage from commercial health insurers and Medicare, potentially transforming access to the test for millions of Americans.
The filing caps a tumultuous period for the company, which launched Galleri as a laboratory-developed test (LDT) in 2021. At that time, its parent company, sequencing giant Illumina, was pursuing a controversial $8 billion acquisition. The deal proceeded without required antitrust approvals, leading to a protracted regulatory battle that ultimately forced Illumina to divest Grail in 2023.
Throughout the corporate upheaval, Grail pressed forward with ambitious clinical trials. The submission to the FDA is bolstered by data from the U.S.-based PATHFINDER 2 study, involving over 25,000 participants, and the massive UK NHS-backed Galleri trial, which enrolled more than 140,000 asymptomatic individuals. The company included a bridging analysis to demonstrate equivalence between the test version used in these trials and the one submitted for regulatory review.
Notably, Grail is seeking approval ahead of final peer-reviewed publications from these studies. Company executives indicated that full data from the UK trial and a complete analysis of a 35,000-participant U.S. cohort are expected around mid-2024.
The commercial stakes are high. Grail reported preliminary 2023 U.S. revenue for Galleri between $136 million and $137 million, with more than 475,000 tests sold commercially as of January. The company projects revenue growth of 22% to 32% by 2026, a forecast likely contingent on favorable regulatory and reimbursement decisions.
The market for multi-cancer screening is heating up. Exact Sciences, itself the target of a $21 billion acquisition by Abbott, launched a competing MCED LDT in late 2023. Meanwhile, Guardant Health has begun offering optional multi-cancer signal detection alongside its FDA-approved Shield colorectal cancer screening test.
Expert Commentary:
"This FDA submission is the moment the entire field has been waiting for," said Dr. Anya Sharma, an oncologist and director of cancer prevention at a major academic medical center. "Robust regulatory scrutiny is essential to validate the clinical utility of these tests and ensure they deliver on the promise of reducing cancer mortality at a population level."
"The potential is enormous, but so is the cost burden," noted Michael Torres, a healthcare policy analyst. "If Medicare agrees to cover Galleri, it could set a monumental precedent and open the floodgates. Payers will need very clear data on whether early detection translates into meaningful, cost-effective improvements in survival outcomes."
"Let's not forget this company's chaotic history—rushed buyouts, regulatory defiance, and now a push for approval before full trial data is public," argued Lisa Chen, a patient advocate and outspoken critic. "It reeks of putting shareholder returns before scientific rigor. We're talking about screening healthy people; the standard of evidence must be impeccable, not expedient."
"As a survivor of a late-stage cancer that lacked routine screening, I see this technology as a beacon of hope," shared David Park, a founder of a patient support network. "The faster we can get validated tools into the hands of doctors, the more lives we can save. The FDA process is there to ensure safety and efficacy, and we should trust it."