Grail Catapults 30%-Plus As FDA Mulls Cancer-Detecting Blood Test

Live updates

1. 21d ago

   Grail Shares Jump as FDA Reviews Galleri Cancer Blood Test

   Grail shares reached a 12-month high following an FDA advisory committee endorsement of the Galleri multi-cancer early detection test. The test targets adults 50 and older and can identify over 50 cancer types from one blood draw. While the panel supported the test's safety and effectiveness as a supplement to standard screening, NCI Director Anthony Letai has raised questions regarding the clinical benefit of the technology. Meanwhile, the SYMPLIFY trial in the UK demonstrated a 75% positive predictive accuracy among patients with suspected symptoms.

   Why it matters

   Early detection often allows for earlier treatment and higher success rates. This blood test aims to reduce reliance on invasive tissue biopsies. The FDA is currently weighing the benefit-risk profile before deciding on formal approval.

   What is confirmed

   • The Galleri test is designed to detect more than 50 types of cancer.
   • An FDA advisory committee backed the safety and effectiveness of the Galleri test for use with standard screening.

   Still unconfirmed

   • Galleri detected cancer signals in 323 people in the SYMPLIFY trial, with 244 later diagnosed with cancer.

   What to watch next

   • FDA final decision on Galleri approval
   • Release of further clinical benefit data from NCI
   • Comparison of Galleri results against Natera's breakthrough status progress
   Sources used for this update (3)

   1. cancerletter.com — As FDA sidesteps the question of Galleri’s clinical benefit ...
   2. www.medicaldaily.com — Natera's Multi-Cancer Blood Test Gets FDA Breakthrough Status ...
   3. pharmaphorum.com — ASCO: Grail’s cancer blood test ‘promising’ in UK trial
   confidence 80%
2. 24d ago

   Grail Soars 30%-Plus as FDA Weighs Cancer-Detecting Blood Test

   Grail shares surged to a 12-month high after a US FDA advisory committee endorsed the Galleri multi-cancer early detection test, designed to spot over 50 cancer types from a single blood draw in adults aged 50 and older. The panel backed the test's benefit-risk profile, safety, and effectiveness for use alongside standard screening. Data showed adding Galleri increased detected cancers over six-fold with a low false-positive rate.

   Why it matters

   The Galleri test aims to detect cancers in apparently healthy individuals. If approved, it could become a significant tool in early cancer detection. The FDA's final decision will impact Grail's future and potential market adoption. Insurer coverage and pricing will also influence the test's uptake.

   What is confirmed

   • Grail shares have climbed following a positive review from a U.S. Food and Drug Administration advisory committee for the Galleri multi-cancer early detection test.
   • The screening tool is designed to spot more than 50 types of cancer in apparently healthy individuals from a single blood draw.
   • Federal health advisers endorsed the benefit-risk profile, safety, and effectiveness of the test for use alongside standard screening in adults aged 50 and older.
   • Data from the PATHFINDER 2 study showed that adding Galleri increased cancers detected through screening more than six-fold with a very low false-positive rate.
   • FDA approval will help, as will insurer adoption of Galleri, but the price that they might be willing to pay for the test is also critical.

   Still unconfirmed

   • a split effectiveness vote and advice to avoid “early” framing leave claims, rivals’ strategies and Medicare coverage unsettled

   What to watch next

   • FDA's final decision on Galleri
   • insurer adoption and pricing of the test
   • Medicare coverage for Galleri
   Sources used for this update (3)

   1. www.fool.com — Grail Stock Hit a 12-Month High After Its FDA Panel Win. But ...
   2. insights.citeline.com — Galleri Panel Aftermath: What Investors And Rivals See Next ...
   3. finance.yahoo.com — Jim Cramer Breaks Down the Stakes in Detail as GRAIL (GRAL ...
   confidence 90%
3. 26d ago

   Grail Stock Jumps as FDA Panel Backs Cancer Blood Test

   Grail shares have climbed following a positive review from a U.S. Food and Drug Administration advisory committee for the Galleri multi-cancer early detection test. The screening tool is designed to spot more than 50 types of cancer in apparently healthy individuals from a single blood draw. Federal health advisers endorsed the benefit-risk profile, safety, and effectiveness of the test for use alongside standard screening in adults aged 50 and older. Data from the PATHFINDER 2 study showed that adding Galleri increased cancers detected through screening more than six-fold with a very low false-positive rate.

   Why it matters

   The regulatory milestone has driven a significant upward trajectory for Grail stock, which has soared over a six-period month and jumped following the panel verdict. Illumina previously acquired Grail before European Union regulators ordered a spin-out that was completed in June 2024. Despite the positive panel vote, the regulatory nod exposes a deep rift between detecting tumor DNA and actually saving patient lives.

   What is confirmed

   • The Galleri multi-cancer early detection test is designed to spot more than 50 types of cancer in apparently healthy individuals from a single blood draw.
   • A U.S. Food and Drug Administration advisory committee voted to support the safety, benefit-risk profile, and effectiveness of the test for adults aged 50 and older alongside standard screening.
   • PATHFINDER 2 study data indicated that adding the test increased cancers detected through screening more than six-fold with a very low false-positive rate.
   • Illumina previously acquired Grail before European Union regulators ordered a spin-out that was completed in June 2024.

   Still unconfirmed

   • Insurance coverage remains a looming question as the cancer blood test nears landmark FDA approval.

   What to watch next

   • Final U.S. Food and Drug Administration approval decision for the Galleri blood test
   • Developments regarding insurance coverage for the screening test
   Sources used for this update (7)

   1. yesilscience.com — FDA Panel Backs Grail Cancer Blood Test - Yesil Science
   2. finance.yahoo.com — Why GRAIL (GRAL) Is Up 12.9% After Positive FDA Panel Verdict ...
   3. finance.yahoo.com — Grail Jumps as Cancer Test Nears Market - Yahoo Finance
   4. www.cherokeephoenix.org — FDA panel endorses first-of-a-kind cancer blood test from ...
   5. y94.com — Grail’s cancer blood test nears landmark FDA approval, but ...
   6. lifescivoice.com — Grail's Cancer Blood Test Nears Landmark FDA Approval
   7. www.marketscreener.com — GRAIL, Inc.: Official Announcements - Stock Market News
   confidence 100%
4. 34d ago

   Grail Shares Surge as FDA Panel Backs Galleri Blood Test

   Grail shares have climbed following a positive review from a U.S. Food and Drug Administration advisory committee for the Galleri multi-cancer early detection test. The panel voted to endorse the benefit-risk profile of the screening tool designed to spot more than 50 types of cancer in apparently healthy individuals. This regulatory milestone has driven a significant upward trajectory for Grail stock, which has soared over a six-month period. Illumina previously acquired Grail before European Union regulators ordered a spin-out that was completed in June 2024.

   Why it matters

   The American biotechnology company based in Menlo Park, California, developed the liquid biopsy test to screen people without symptoms by identifying floating DNA signals from cancer cells. While the advisory committee delivered a supportive vote, advisers warned that performance uncertainties remain regarding the technology. The company now awaits a final regulatory decision from the Food and Drug Administration.

   What is confirmed

   • A U.S. Food and Drug Administration advisory committee voted to back Grail's Galleri multi-cancer early detection test.
   • Grail stock has soared 180 percent over a six-month period.
   • The Galleri test is designed to look for a signal shared by more than 50 types of cancer using a single blood test in people without symptoms.
   • Illumina bought Grail outright in 2021 before EU regulators ordered a spin-out that was completed on June 24, 2024.

   What to watch next

   • A final decision from the Food and Drug Administration regarding the approval of the Galleri test.
   Sources used for this update (8)

   1. www.galleri.com — Blood Test for Cancer Screening | Galleri®
   2. www.centraloregondaily.com — A controversial, cancer-detecting blood test just got backed ...
   3. www.fool.com — Grail Stock Has Soared 180% in 6 Months. Here's Why the Stock ...
   4. grail.com — Home - GRAIL
   5. grail.com — FDA Advisory Committee Votes In Favor of Approval of GRAIL’s ...
   6. en.wikipedia.org — Grail, Inc. - Wikipedia
   7. en.wikipedia.org — Holy Grail - Wikipedia
   8. finance.yahoo.com — GRAIL, Inc. (GRAL) Stock Price, News, Quote & History - Yahoo ...
   confidence 100%
5. 38d ago

   FDA Panel Backs Grail Galleri Cancer Blood Test

   Federal health advisers voted to endorse Grail and its Galleri multi-cancer blood test. The panel delivered a 7-2 vote supporting the benefit-risk profile for the test, which aims to spot various cancers in apparently healthy individuals. Advisers issued warnings that uncertainty remains regarding how well the technology performs. The regulatory hurdle marks a significant step for the company as it awaits a final decision from the Food and Drug Administration. The recommendation also lifted market expectations and shares for Samsung Electronics and Samsung C&T.

   Why it matters

   The multi-cancer early detection test claims to identify multiple early-stage cancers, though it faces scrutiny over limited data concerning patient outcomes and efficacy. Gaining approval would establish a first-of-a-kind regulatory pathway for screening tests designed to catch multiple malignancies before symptoms appear.

   What is confirmed

   • An FDA advisory panel recommended approval of Grail's Galleri multi-cancer test with a 7-2 vote.
   • The federal health advisers endorsed the blood test designed to spot signs of various cancers in apparently healthy people.
   • Advisers warned that it remains unclear how well the technology works and noted limited data on efficacy and patient outcomes.
   • The FDA panel recommendation is expected to benefit Samsung Electronics and Samsung C&T.

   Still unconfirmed

   • The Galleri test claims to find multiple early-stage cancers despite limited data on efficacy and patient outcomes.

   What to watch next

   • A final regulatory decision from the Food and Drug Administration regarding the Galleri test approval path.
   Sources used for this update (7)

   1. www.mercurynews.com — Grail's cancer blood test faces high-stakes FDA review
   2. www.yahoo.com — FDA panel endorses first-of-a-kind cancer blood test from Grail
   3. www.usatoday.com — Galleri cancer blood test backed by FDA panel. Why it's ...
   4. www.fiercebiotech.com — Grail survives adcomm vote as it awaits FDA decision
   5. en.sedaily.com — FDA Panel Backs Grail Cancer Test, Lifting Samsung Bets
   6. insider.fitt.co — GRAIL’s Galleri Cancer Blood Test Moves Closer to FDA ...
   7. marketchameleon.com — GRAL jumps as FDA panel backs Galleri, with a 7–2 benefit ...
   confidence 100%
6. 45d ago

   Grail Shares Surge as FDA Staff Report No Major Concerns for Galleri Test

   Grail stock rose more than 30% following the release of FDA briefing documents that showed a positive evaluation of its Galleri multi-cancer blood test. FDA staff indicated they have no major concerns regarding the test, which is designed to detect cancer in healthy individuals. This rally marks the company's best trading day in over 1.5 years. The positive internal review comes just as the FDA prepares for an advisory committee meeting to evaluate the test's efficacy and regulatory approval path.

   Why it matters

   The Galleri test aims to identify multiple types of cancer through a single blood draw before symptoms appear. Regulatory approval from the FDA is required for the test to be marketed as a diagnostic tool for the general population. A positive outcome from the advisory committee could significantly expand the company's market reach.

   What is confirmed

   • Grail stock increased by more than 30%.
   • FDA staff reported no major concerns regarding the multi-cancer test.
   • The Galleri test is designed to detect signs of multiple cancers in healthy people.
   • Grail experienced its best trading day in more than 1.5 years.

   What to watch next

   • The outcome of the FDA advisory committee vote on the Galleri test.
   • Official FDA decision on regulatory approval for the blood test.
   Sources used for this update (8)

   1. Investor's Business Daily — Grail Catapults 30%-Plus As FDA Mulls Cancer-Detecting Blood Test
   2. Reuters — Grail rallies as FDA staff flags no major concerns for multi-cancer test
   3. Yahoo Finance — GRAL Stock Clocks Best Day In Over 1.5 Years — FDA Papers Lift Galleri Approval Hopes
   4. Endpoints News — FDA offers little comment on Grail cancer test ahead of adcomm
   5. Seeking Alpha — GRAIL surges as FDA briefing doc shows positive evaluation of Galleri cancer test
   6. WSJ — Opinion | A Grail Cancer Test for the FDA
   7. STAT — What a vote on Grail’s cancer detection test could mean for the company, patients, and regulators
   8. medicalxpress.com — Grail's cancer blood test faces high-stakes FDA review
   confidence 95%