On September 23, Eastern Time, the Molecular and Clinical Genetics Panel, a subdivision of the FDA's Medical Devices Advisory Committee, convened a public meeting to review GRAIL's Premarket Approval (PMA) application for its Galleri multi-cancer detection product.

Galleri's decade-long journey reaches a review milestone Galleri is the first multi-cancer screening product globally to submit a PMA and enter the FDA advisory committee review stage. Ten voting experts cast separate ballots on safety, effectiveness, and overall benefit-risk profile: safety received unanimous support; effectiveness passed 6-4, with four experts voting against; and benefit-risk passed 7-2-1, with one abstention. The three votes collectively point toward recommending approval of Galleri for multi-cancer screening in individuals aged 50 and older. The advisory committee's vote is non-binding on the FDA, which retains sole authority over whether and when to grant approval. The significance of this vote lies in its role as a window into how the FDA evaluates this class of multi-cancer screening products, with the regulatory stringency directly influencing submission expectations for all subsequent similar products.

Galleri is a next-generation sequencing (NGS)-based blood test for multi-cancer early detection. Rather than directly identifying tumor cells, it isolates cell-free DNA (cfDNA) from peripheral blood and reads cancer-specific methylation patterns: DNA fragments shed by cancer cells carry methylation signatures distinct from normal cells, and differences exist across cancers of different tissue origins. As such, the test can determine whether a cancer signal is present in asymptomatic adults over 50, and when a signal is detected, predict the cancer signal origin (CSO) to guide imaging or biopsy pathways. Per its intended use, it covers dozens of cancer types, including pancreatic, ovarian, liver, and esophageal cancers that currently lack recommended screening methods. It is positioned as a complement to, not a replacement for, existing single-cancer screenings; a result of "no cancer signal detected" does not rule out cancer, and individuals should still undergo established screenings for breast, cervical, colorectal, and lung cancers per guidelines. The product is prescription-only, performed at GRAIL's own laboratory, with a list price of $949, and $799 out-of-pocket at some channels.

Evidence supporting the PMA submission primarily comes from two studies. First is the PATHFINDER 2 study: a prospective, multicenter, interventional study conducted in the United States (including Canada), enrolling approximately 35,000 individuals aged 50 and older who met guideline-based screening criteria. At the 2026 ASCO Annual Meeting, GRAIL reported results from 35,878 participants: adding Galleri to breast, cervical, colorectal, and lung cancer screening increased cancer detection by more than sevenfold within one year; when prostate screening was included in standard screening, the incremental increase was approximately threefold. Specificity was 99.6%, positive predictive value 60.3%, signal origin prediction accuracy 91.3%, and approximately 53% of new cancers were detected at Stage I or II. About 0.6% of participants underwent invasive diagnostic procedures, with a median time from positive result to diagnosis of 48 days. The PMA module submitted to the FDA incorporates data from 25,490 participants who completed one-year follow-up.

The other study is the NHS-Galleri study in the United Kingdom: according to the executive summary published by the FDA before the meeting, the project enrolled 142,826 asymptomatic individuals (142,250 randomized), making it the largest and only randomized controlled trial of an MCED test conducted in the intended use population to date. Its results are more complex. The primary endpoint, a reduction in the combined incidence of Stage III and IV cancers across 12 prespecified cancer types, was not met. However, on key secondary endpoints, Stage IV cancer was reduced by 14% after three years of screening (342 cases vs. 397 cases), with the reduction expanding by round: 9% in year one, 22% in year two, and 26% in year three. Stage I and II cancers increased by 16%. Across all cancer types, the intervention group had 3,637 diagnoses versus 3,400 in the control group; among screen-detected cancers, the intervention group had 1,173 cases versus 290 in the control group, an approximately fourfold difference; clinically detected cancers were reduced by 21% (per ASCO abstract LBA100). On test performance, the study reported specificity of 99.55%, positive predictive value of 52%, negative predictive value of 98.92%, sensitivity of 54.7% for the 12 prespecified cancers and 30.7% for all cancers, and signal origin prediction accuracy of 87% when a single site was reported, rising to 92.5% when the top two sites were reported.

A core controversy surrounding Galleri is that NHS-Galleri has not demonstrated that early detection translates into reduced mortality, i.e., it cannot prove a reduction in cancer deaths. Furthermore, because Galleri screens for more than 50 cancer types in a single test, it is highly prone to detecting indolent, low-aggressiveness tumors. Researchers acknowledge that it cannot be determined whether all cancers detected by Galleri would progress to clinically significant disease, and the risk of overdiagnosis cannot be excluded. Whether early detection improves ultimate survival outcomes will require longer follow-up.

Galleri's path to this point has been arduous. GRAIL was incubated by sequencing equipment leader Illumina in 2016. During funding rounds around 2017, Bill Gates and Jeff Bezos participated in early investments, with Illumina holding approximately 20% at the time. In September 2020, Illumina announced the acquisition of GRAIL for approximately $8 billion in cash and stock. In March 2021, the U.S. Federal Trade Commission (FTC) filed an administrative action to block the vertical merger; in July of the same year, the European Commission launched an in-depth investigation. On August 18, 2021, with neither review concluded, Illumina completed the acquisition for approximately $7.1 billion. What followed was over three years of legal battles: in October 2021, the European Commission ordered Illumina to keep GRAIL operationally independent; in September 2022, the European Commission prohibited the acquisition and ordered divestiture; in March 2023, the FTC unanimously determined the acquisition substantially reduced competition in violation of the Clayton Act and ordered divestiture; in July 2023, the European Commission fined Illumina €432 million for completing the acquisition without approval; in October 2023, the European Union required divestiture within twelve months; and in December 2023, the U.S. Fifth Circuit Court of Appeals denied most of Illumina's rehearing requests. On June 24, 2024, Illumina completed the divestiture via spin-off, making GRAIL (Nasdaq: GRAL) an independent publicly traded company; in August of that year, the FTC approved withdrawal of its complaint. In March 2026, then-CEO Bob Ragusa announced retirement, and the board appointed former President Josh Ofman to succeed him effective June 1. Ofman joined in 2019, having previously spent over 15 years at Amgen, where his final role was Senior Vice President of Global Value, Access, and Policy.

Financially, the company remains loss-making: total revenue for the second quarter of 2026 was $44.67 million, up 26% year-over-year, with Galleri revenue of $42.6 million and test volumes exceeding 61,000, up 35%. First-half Galleri revenue was $82.5 million, up 30%, with test volumes exceeding 117,000, up 42%. Net loss for the period was $110.2 million, with adjusted EBITDA at negative $90.3 million. As of June 30, cash and short-term marketable securities totaled $861.6 million. In June 2026, the company completed a $110 million equity financing with Samsung C&T and Samsung Electronics as investors, who also plan to collaborate on promoting Galleri in South Korea and explore expansion into other Asian markets.

Finally, on the payer front, the reimbursement door has effectively opened in advance. First is at the Congressional level. On February 3, 2026, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R.842) was signed into law as part of the 2026 Consolidated Appropriations Act, establishing a pathway for Medicare coverage of MCED: once a test receives FDA approval and demonstrates clinical benefit, CMS is authorized to include it in coverage, while retaining the authority to determine coverage parameters through an evidence-based process, and clarifying that such tests are complementary to, not replacements for, existing screenings, without affecting cost-sharing. Under prior rules, even if an MCED gained FDA approval, Medicare coverage could have taken more than a decade. Second is the FDA's regulatory stance on laboratory-developed tests (LDTs). In May 2024, the FDA issued a final rule bringing laboratory-developed tests under device regulation with a phased compliance timeline; on March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the rule, finding the FDA exceeded its statutory authority and that LDTs should remain governed by the Clinical Laboratory Improvement Amendments (CLIA) framework. The FDA did not appeal and on September 19, 2025, issued a rule reverting to the original text, returning LDTs to a state of "enforcement discretion"; the FDA estimates this saves approximately $1.44 billion annually. This backdrop explains GRAIL's position: Galleri has been sold in the U.S. as an LDT under the CLIA framework and does not require FDA approval for commercialization. Pursuing the PMA pathway voluntarily is a move to exchange stricter review for formal approval status, which is a prerequisite for unlocking Medicare coverage and private insurance reimbursement.

The next phase for domestic multi-cancer early screening, with pioneers like BGI Genomics Turning attention back to China. Currently, no pan-cancer early detection product has received NMPA approval for marketing. The industry is in a phase of parallel clinical validation and commercialization exploration. Single-cancer methylation-based products have reached relative commercial maturity, and multi-cancer combination tests for digestive system cancers have been launched densely in the past two years. Pan-cancer tests comparable to Galleri are generally in technical prototype and early clinical validation stages. The reference value of Galleri's regulatory review for domestic companies lies not in replicating its data, but in understanding what endpoints, populations, and follow-up durations the FDA uses to evaluate a multi-cancer early screening product. This evaluation framework is likely to inform subsequent domestic regulatory reviews.

Among domestic companies, a group of pioneers has been persistently exploring cancer early screening. Take BGI Genomics as an example. The company builds on multi-omics technologies including gene sequencing, mass spectrometry, and bioinformatics analysis. Its tumor early screening business is anchored on a DNA methylation detection platform, forming a product and service matrix covering colorectal, gastric, liver, cervical, and urothelial cancers among high-incidence cancer types. The clearest demonstration of large-scale deployment capability is the public health program model: a cancer screening program in Harbin covering 2.4 million permanent residents uses its stool-based DNA methylation detection solution, with residents completing sample collection at home and community institutions handling centralized specimen transport. At a time when the early screening industry generally struggles with screening adherence, this delivery scale has no publicly disclosed equivalent among domestic peers.

In the multi-cancer direction, BGI Genomics also initiated early布局 and has launched a five-cancer blood-based methylation early detection product for the digestive system, enabling risk assessment for colorectal, gastric, esophageal, liver, and pancreatic cancers from a single blood draw. Its more advanced pan-cancer detection technical prototype based on methylation markers has completed technology upgrades and is currently in clinical validation, with future plans to pursue application trials and commercialization exploration based on this foundation.

Drawing on Galleri's experience, the real dividing line for domestic companies is not the technology platform, as methylation detection combined with machine learning has become a convergent path across the industry. The critical factors are: first, whether prospective clinical studies at the scale of PATHFINDER 2 and NHS-Galleri can be executed; and second, whether the diagnostic pathway integration after detection and health economics evidence can form a closed loop. The questions Galleri faces in the U.S. will eventually be posed to every domestic MCED participant. For manufacturers like BGI Genomics, large-scale delivery has already been proven, constituting a genuine first-mover advantage in the industry. What remains to be addressed is the clinical evidence component. All in all, the future holds promise.