Source Details

{
    "source_type": "extension",
    "content_hash": "84a62f728bc56f99712e43454230afe7c07941894081be33662b49e59ef95503",
    "submitted_via": "chrome_extension",
    "extension_version": "1.0.18",
    "original_url": "https:\/\/www.nytimes.com\/2026\/09\/23\/well\/fda-cancer-blood-test-galleri-grail.html?emc=edit_hh_20260925&nl=well&segment_id=227037",
    "parsed_content": "U.S. Health PolicyMedicaid Drug PricesKennedy Assures Vaccine SkepticsHealth Panel OverhauledDelayed Child Covid VaccinesFall Vaccine GuidanceAdvertisementSKIP ADVERTISEMENTSupported bySKIP ADVERTISEMENTF.D.A. Advisory Panel Endorses Controversial Cancer Blood TestThe panelists expressed reservations about the evidence supporting Grail\u2019s Galleri test, which is designed to detect cancers early.Listen \u00b7 5:33 min Share full articleCredit...Misha Friedman for The New York TimesBy Nina AgrawalSept. 23, 2026An advisory committee to the Food and Drug Administration recommended on Wednesday that the agency approve a blood test designed to detect various cancers in the early stages, despite concerns among doctors about the test\u2019s efficacy.The test, which is called Galleri and is manufactured by Grail, is one of a handful of so-called early detection blood tests that claim to be able to find multiple cancers at early stages. The idea of catching cancers sooner with a simple blood test has generated tremendous hope. But oncologists and screening experts have expressed concerns that Grail\u2019s test has not been shown to reduce cancer deaths, and they have warned that the possible risks, including harm to patients and increased health care costs, may outweigh any potential benefits.The test works by analyzing DNA fragments in the blood for certain patterns indicative of cancer. While it has not yet been approved by the F.D.A., it has been available to people in the United States since 2021 through a regulatory exception. Hundreds of thousands of people have taken a Galleri test, including 117,000 in the first half of this year. (That number does not count those who have taken the test as part of research.)But there is no data from randomized controlled trials that shows that Galleri or any similar test reduces cancer deaths \u2014 the gold standard for cancer screening. Grail conducted a large randomized trial in the United Kingdom to assess whether the test shifted cancer diagnoses earlier, with the thinking being that earlier-stage cancers have better prognoses. But the company announced in February that the test failed to reduce Stage 3 and 4 cancer diagnoses.AdvertisementSKIP ADVERTISEMENT\u201cThat\u2019s why nobody in the oncology community is recommending this test,\u201d said Dr. Scott Ramsey, the director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center in Washington. Dr. Ramsey is leading a study funded by the National Cancer Institute, or N.C.I., to assess the feasibility of using multi-cancer detection tests.Currently, most patients must pay out of pocket for Grail\u2019s test, which has a list price of $949. But the company spent millions successfully lobbying for legislation that would authorize Medicare to cover the test beginning in 2028 if the F.D.A. approves it. Other insurers could also choose to cover the test if it were to be approved.At the meeting, Grail executives emphasized that the test produced a low false-positive rate and that a majority of the cancers it detected were at Stage 1, 2 or 3. The company also said the test detected cancers for which there is no current guideline-recommended screening, such as liver and pancreatic cancer.But F.D.A. representatives noted at the meeting that, across both the U.K. trial and a U.S. study, the test only detected one out of every three cancers diagnosed by doctors within a 12-month period.\u201cThat\u2019s not as good as a coin toss,\u201d Diana Zuckerman, the president of the National Center for Health Research, a nonprofit health policy research group, said in a public comment session during the meeting.AdvertisementSKIP ADVERTISEMENTThe detection rate was higher among more advanced cancers.Philip Castle, the director of the cancer prevention division at the N.C.I., said during the meeting that the test\u2019s ability to detect cancers in the early stages, \u201cwhere intervention matters the most, remains poor.\u201dBeyond the questions of efficacy, experts have warned of other risks, including that the test could lead to overdiagnosis, which occurs when screening detects cancers that may be slow-growing or not aggressive enough to cause symptoms. This can create costs for patients and the health system without delivering any clear benefit.They have also expressed concern that false-positive results could lead to anxiety and distress among patients.F.D.A. representatives, panelists and members of the public also said at the meeting they were worried that patients who receive negative results may forgo evidence-based cancer screenings like mammograms or colonoscopies \u2014 even if the test labeling indicates that they should continue.\u201cWhen they start having symptoms, there will be a tendency to avoid going to the doctor, just delaying a little bit,\u201d Dr. Zuckerman said. \u201cAnd that could be deadly.\u201dAdvertisementSKIP ADVERTISEMENTThe panelists appeared to be swayed by the findings that the test detected cancers that don\u2019t have routine screenings, though they acknowledged that the clinical benefit of that detection remained unknown. They also cited the low rate of false-positive results and small number of invasive procedures performed among those patients as favorable safety signs.But the panelists generally concurred that they couldn\u2019t confidently say Galleri could be described as an \u201cearly\u201d detection test, and a number of them said that without data on patients\u2019 clinical outcomes, they couldn\u2019t be sure of the test's effectiveness.\u201cAs an oncologist, I generally look at that as outcomes, and we don\u2019t have that data,\u201d said Dr. Stanley Lipkowitz, chief of the women\u2019s malignancies branch at the N.C.I. and a member of the panel.\u201cIf we approve this without that,\u201d he added, \u201call the subsequent tests won\u2019t need that either. We need to set the bar here higher because it is the first one.\u201dAdvertisementSKIP ADVERTISEMENT",
    "published_at": "2026-09-23T22:45:41+00:00",
    "author_name": "Nina Agrawal",
    "site_name": "The New York Times",
    "section": "U.S. Health Policy",
    "publisher": "The New York Times Company",
    "ai_headline": "F.D.A. Advisory Panel Endorses Controversial Cancer Blood Test",
    "ai_simplified_title": "FDA Panel Endorses Controversial Cancer Blood Test Despite Efficacy Concerns",
    "ai_excerpt": "An FDA advisory committee recommended approval for Grail's Galleri blood test, designed to detect various cancers early, despite concerns from doctors about its efficacy and lack of data showing reduced cancer deaths. The test has been available since 2021, but experts warn of risks like overdiagnosis and false positives.",
    "ai_subject_tags": [
        "FDA",
        "Cancer Screening",
        "Blood Tests",
        "Medical Technology",
        "Health Policy",
        "Oncology",
        "Grail Galleri"
    ],
    "ai_context_type": "News",
    "ai_context_details": {
        "tone": "informative",
        "perspective": "neutral",
        "audience": "general",
        "credibility_indicators": [
            "expert_quotes",
            "data_cited",
            "regulatory_body_discussion"
        ]
    },
    "ai_source_vector": null,
    "ai_confidence_score": 0.9999999999999999,
    "ai_extraction_metadata": {
        "extracted_at": "2026-09-25T01:04:05.906410Z",
        "ai_model": "gemini-2.5-flash",
        "extraction_method": "automated",
        "content_length": 5917,
        "metadata_prompt_body_chars": 5917,
        "metadata_prompt_truncated": false,
        "url": "https:\/\/nytimes.com\/2026\/09\/23\/well\/fda-cancer-blood-test-galleri-grail.html",
        "existing_metadata": {
            "author_name": null,
            "published_at": null,
            "domain_name": "nytimes.com",
            "site_name": null,
            "section": null,
            "publisher": null
        },
        "openai_refusal_gemini_fallback": false
    }
}

{
    "extracted_at": "2026-09-25T01:04:05.906410Z",
    "ai_model": "gemini-2.5-flash",
    "extraction_method": "automated",
    "content_length": 5917,
    "metadata_prompt_body_chars": 5917,
    "metadata_prompt_truncated": false,
    "url": "https:\/\/nytimes.com\/2026\/09\/23\/well\/fda-cancer-blood-test-galleri-grail.html",
    "existing_metadata": {
        "author_name": null,
        "published_at": null,
        "domain_name": "nytimes.com",
        "site_name": null,
        "section": null,
        "publisher": null
    },
    "openai_refusal_gemini_fallback": false
}