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GRAIL faces FDA advisory panel review for Galleri cancer blood test
GRAIL, Inc. is facing a critical regulatory milestone as an FDA advisory panel reviews the Galleri multi-cancer early detection blood test. The Molecular and Clinical Genetics Panel is scheduled to vote on whether the test's benefits outweigh potential risks, such as false alarms or missed diagnoses, for adults aged 50 and older.
FDA reviewers have indicated they have no major outstanding concerns regarding the test's primary safety analysis. However, they have requested the panel to evaluate whether clinical performance data supports the company's proposed labeling for 'early' cancer detection. This follows findings from the PATHFINDER 2 study, which enrolled 35,878 participants across the United States and Canada.
Results from the PATHFINDER 2 study, published in Nature Medicine, showed that the Galleri test demonstrated a specificity of 99.64% and a positive predictive value of 60.3%. Among participants with newly diagnosed primary cancers, 53% were in stage 1 or 2, and 70.9% were in stage 1, 2, or 3. The test also correctly predicted the likely origin of the cancer signal in 91.3% of cases.
An FDA approval could significantly expand the test's availability by facilitating coverage from Medicare and private insurers. GRAIL expects a final FDA decision on the premarket approval application by early 2027.
Entities
FDA · Food and Drug Administration · GRAIL, Inc. · Galleri · Grail Inc. · Mayo Clinic · Oregon Health & Science University
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 3 SOURCES] The test correctly predicted the likely origin of the cancer signal in 91.3% of cases. www.hna.de · www.merkur.de · www.newswise.com
- [● 2 SOURCES] The PATHFINDER 2 study enrolled 35,878 adults aged 50 and older across the United States and Canada. www.news-medical.net · www.newswise.com
- [● 6 SOURCES] An FDA advisory panel is reviewing the Galleri test to determine if its benefits outweigh risks like false alarms or missed cancers. srnnews.com · www.news-medical.net · mugglehead.com · www.finanzen.at · www.finanzen.ch · +1 more
- [● 3 SOURCES] Among participants with newly diagnosed primary cancers, 53% were in stage 1 or 2 and 70.9% were in stage 1, 2, or 3. www.hna.de · www.merkur.de · www.newswise.com
- [● 4 SOURCES] The Galleri test uses a machine-learning algorithm to analyze cell-free DNA fragments in the blood. www.hna.de · www.merkur.de · www.news-medical.net · www.newswise.com
- [● 3 SOURCES] The Galleri test demonstrated a positive predictive value of 60.3% and a specificity of 99.64%. www.hna.de · www.merkur.de · www.newswise.com
- [● 4 SOURCES] The Galleri test is a prescription blood test designed for adults aged 50 and older. srnnews.com · www.finanzen.at · www.finanzen.ch · newsable.asianetnews.com
- [● 3 SOURCES] FDA reviewers reported no major outstanding questions regarding the test's primary safety analysis. mugglehead.com · srnnews.com · newsable.asianetnews.com
- [● 3 SOURCES] The FDA has asked the advisory panel to determine if the test's performance supports its proposed labeling for 'early' cancer detection. mugglehead.com · srnnews.com · newsable.asianetnews.com