Oral Statement of Dr. Diana Zuckerman at the FDA Advisory Panel Meeting on the Galleri Multi-Cancer Screening Test on September 24, 2026

September 23, 2026: NCHR’s Diana Zuckerman testifies at FDA panel meeting on Galleri multi-cancer screening test, stating that the test fails to accurate predict early cancers. The test misses more early cancers than a coin toss, and those false negatives can lead to patients delaying medical visits when symptoms appear. Those delays can be deadly. Though the test is less likely to tell people they have cancer when they don’t, those who are misinformed will undergo many weeks of anxiety as well as additional, often invasive tests. Most important, there is no evidence that the test saves lives or improves quality of life, since most cancers detected are late stage.

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Stakeholders Letter from National Center for Health Research, Doctors for America, Generation Patient, and U.S. PIRG to FDA PDUFA Negotiators

April 17, 2026: National Center for Health Research and Stakeholder partners wrote to FDA PDUFA user fees negotiators to express our concerns that FDA had ignored our repeated requests for PDFUA to include performance goals aimed at improving scientific standards and evidence that will ensure that drugs and biologics have meaningful benefits for patients that outweigh any risks.

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NCHR Written Comment on FDA’s Review of the Galleri Multi-Cancer Early Detection Test

September 8, 2026: In response to a request for public comments, NCHR urged the FDA not to approve Galleri multi-cancer screening blood test until it is proven to help patients live longer or improve their quality of life. Its accuracy must be improved to show its benefits outweigh the physical, emotional, and financial burdens of inaccurate results and follow-up testing. NCHR also emphasized Galleri’s limited sensitivity, particularly for early-stage cancers, and warned that it should not replace recommended cancer screenings.

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