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HealthResurging · day 3

FDA panel votes on Grail's Galleri multi-cancer blood test

An independent FDA advisory panel decides whether to recommend Grail's 50-cancer blood test, a call that could open the door to Medicare coverage.

newest coverage 5h agosummary written 14h ago27 pieces1 likes & upvotes NewswiresGoogle NewsMastodon

What to know

  • An FDA advisory panel, the Molecular and Clinical Genetics Panel, is voting on whether to recommend approval of Grail's Galleri blood test, which screens for signals of up to 50 cancers.
  • Grail shares surged 33% after the FDA posted meeting documents that appeared to signal a favorable view ahead of the vote.
  • A large NHS-linked trial showed Galleri increased detection of early-stage cancers but did not reduce the total number of late-stage diagnoses compared with a control group, a point of dispute between supporters and critics.
  • FDA approval would not require insurance coverage but is widely seen as a step toward Medicare and private-payer reimbursement for the test, which currently costs $799 out of pocket.

“The multi-cancer blood test is proven to increase early detection that can save lives.”

WSJ Editorial Board, Opinion board · WSJ Opinion ↗ · Sep 19

Grail Inc. Maker of the Galleri multi-cancer blood testFDA Molecular and Clinical Genetics Panel Independent advisory panelVinay Prasad Former FDA biologics chiefWSJ Editorial Board Opinion commentator

FDA panel votes on Grail's Galleri multi-cancer blood test
STAT News

How it unfolded 6 developments, newest first · click a bar or a number to jump articlesposts

Peak 7 pieces in one hour at Yesterday, 8 AM; 27 pieces over 3 days (18 articles · 9 posts) Sep 20, 3 PM — 1 piece · 1 article — Newswires 1Sep 20, 4 PM — quietSep 20, 5 PM — quietSep 20, 6 PM — quietSep 20, 7 PM — quietSep 20, 8 PM — quietSep 20, 9 PM — quietSep 20, 10 PM — quietSep 20, 11 PM — quietSep 21, 12 AM — quietSep 21, 1 AM — quietSep 21, 2 AM — quietSep 21, 3 AM — 1 piece · 1 article — Newswires 1Sep 21, 4 AM — quietSep 21, 5 AM — quietSep 21, 6 AM — quietSep 21, 7 AM — quietSep 21, 8 AM — quietSep 21, 9 AM — quietSep 21, 10 AM — quietSep 21, 11 AM — quietSep 21, 12 PM — 1 piece · 1 article — Newswires 1Sep 21, 1 PM — quietSep 21, 2 PM — quietSep 21, 3 PM — 3 pieces · 3 articles — Google News 3Sep 21, 4 PM — quietSep 21, 5 PM — quietSep 21, 6 PM — quietSep 21, 7 PM — quietSep 21, 8 PM — quietSep 21, 9 PM — quietSep 21, 10 PM — quietSep 21, 11 PM — quietSep 22, 12 AM — quietSep 22, 1 AM — quietSep 22, 2 AM — quietSep 22, 3 AM — quietSep 22, 4 AM — quietSep 22, 5 AM — quietSep 22, 6 AM — quietSep 22, 7 AM — quietSep 22, 8 AM — quietSep 22, 9 AM — quietSep 22, 10 AM — quietSep 22, 11 AM — quietSep 22, 12 PM — quietSep 22, 1 PM — quietSep 22, 2 PM — quietSep 22, 3 PM — quietSep 22, 4 PM — quietSep 22, 5 PM — quietSep 22, 6 PM — quietSep 22, 7 PM — quietSep 22, 8 PM — quietSep 22, 9 PM — quietSep 22, 10 PM — quietSep 22, 11 PM — quietYesterday, 12 AM — quietYesterday, 1 AM — quietYesterday, 2 AM — quietYesterday, 3 AM — quietYesterday, 4 AM — quietYesterday, 5 AM — 6 pieces · 2 articles · 4 posts — Mastodon 4, Newswires 2Yesterday, 6 AM — quietYesterday, 7 AM — 1 piece · 1 article — Newswires 1Yesterday, 8 AM — 7 pieces · 5 articles · 2 posts — Newswires 5, Mastodon 2Yesterday, 9 AM — quietYesterday, 10 AM — quietYesterday, 11 AM — quietYesterday, 12 PM — quietYesterday, 1 PM — quietYesterday, 2 PM — quietYesterday, 3 PM — 2 pieces · 1 article · 1 post — Mastodon 1, Newswires 1Yesterday, 4 PM — 1 piece · 1 article — Newswires 1Yesterday, 5 PM — 3 pieces · 2 articles · 1 post — Google News 2, Mastodon 1Yesterday, 6 PM — 1 piece · 1 post — Mastodon 1Yesterday, 7 PM — quietYesterday, 8 PM — quietYesterday, 9 PM — quietYesterday, 10 PM — quietYesterday, 11 PM — quiet 1234–6
Sep 21Sep 22yesterdaynow · 12:58 AM ET
  1. 6

    Molecular and Clinical Genetics Panel weighs clinical evidence

    Quartz identifies the reviewing body as the FDA's Molecular and Clinical Genetics Panel, which is assessing Galleri's clinical evidence with Medicare coverage potentially following approval.

    1. 1 outlet FDA advisers are voting on Grail's multicancer blood test as Medicare coverage hangs in the balance

      first by Quartz, 15h ago

    • Grail’s Multi-Cancer Blood Test Gets FDA Committee Vote for Premarket Approval https://www. wsj.com/health/healthcare/grai ls-multi-cancer-blood-test-gets-fda-committee-vote-for-premarket-approval-24f5aa90?mod=Flipboard&utm_source=flipboard&utm_medium=activitypub Posted into Latest From the WSJ @ latest-from-the-wsj-WSJ

      WSJ@flipboard.comMastodon6h agoview on Mastodon ↗
    1 more of the top 2 · 2 posts in this stretch

    • FDA panel endorses first-of-a-kind cancer blood test from Grail https:// apnews.com/article/grail-test- cancer-fda-dna-8fc5480be365b59c450043daa38cad30?utm_source=flipboard&utm_medium=activitypub Posted into U.S. News @ u-s-news-AssociatedPress

      AssociatedPress@flipboard.comMastodon5h agoview on Mastodon ↗
    all of them →
  2. 5

    Wire reports frame review as high-stakes first hurdle

    AP wire coverage describes the panel review as the first major U.S. regulatory hurdle for a blood test designed to hunt signs of multiple cancers in healthy people by detecting DNA fragments shed by tumor cells.

    1. 7 outlets Grail’s cancer blood test faces high-stakes FDA review

      first by Chicago Tribune, 8h ago · also STAT News, NPR, Baltimore Sun, Mercury News, Orlando Sentinel, Philadelphia Inquirer

      2 more headlines

    • Get the most important and interesting news from the global economy delivered to your inbox. https:// qz.com/fda-advisers-grail-gall eri-multicancer-blood-test-092326?utm_source=flipboard&utm_medium=activitypub Posted into Business News @ business-news-quartz

      quartz@flipboard.comMastodon15h agoview on Mastodon ↗
  3. 4

    Medicare coverage floated as approval's likely payoff

    Coverage notes that FDA approval could pave the way for Medicare reimbursement, even though a major study of the test failed to prove it could detect later-stage cancers.

    1. 1 outlet FDA advisers are reviewing a multicancer-detection test. Medicare coverage could follow.

      first by MarketWatch, 16h ago

  4. 3

    FDA's outside expert panel meets to vote on Galleri

    An independent panel of experts convenes to decide whether the Galleri multi-cancer blood test, which Grail says can detect up to 50 forms of cancer, should be recommended for FDA approval.

    1. 2 outlets Will FDA advisers recommend a multi-cancer blood test for approval? They'll vote

      first by NPR Health, 18h ago · also NPR News

    2. 1 outlet Blood test for multiple cancers clears crucial hurdle on track to FDA approval

      first by Scientific American, 6h ago

  5. 1 day quiet
  6. 2

    Grail shares surge 33% on FDA meeting documents

    Grail's stock jumped after the FDA posted documents ahead of the advisory committee meeting that suggested the agency may take a favorable view of the Galleri test; the FDA is not bound by the panel's advice but often follows it.

    “The real reason some so-called experts oppose FDA approval is because it could lead to government and private insurance coverage.”
    — WSJ Editorial Board, Opinion board · source
    1. 4 outlets A Grail Cancer Test for the FDA

      first by Hindustan Times, 2d ago · also STAT, WSJ, Investor's Business Daily

      4 more headlines
  7. 1

    WSJ editorial board urges FDA to clear the test

    The Wall Street Journal's Editorial Board argues Galleri's trial data show it increases early cancer detection and accuses critics of wanting to ration care ahead of the FDA panel's review.

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