Cancer blood test faces high-stakes FDA review, tell me about this news in (https://www.nbcnews.com/health/cancer/cancer-blood-test-faces-high-stakes-fda-review-rcna599426)

The news centers on an FDA advisory committee meeting convened to evaluate whether to recommend approval for the first multi-cancer early detection blood test, developed by Grail and known as the Galleri test.

Key highlights of the news:

• What the test does: The Galleri test checks for cancer-specific DNA methylation patterns shed into the bloodstream, designed to screen for up to 50 types of cancer in asymptomatic adults aged 50 and older. If it detects signs of cancer, it also predicts where in the body the tumor originated.

• High-stakes regulatory milestone: While multi-cancer screening tests have been sold under clinical laboratory regulations, none have secured official FDA approval. Gaining FDA clearance would formally validate the emerging category of multi-cancer early detection (MCED) and open the door to Medicare coverage and broader insurance reimbursement.

• Clinical controversy and limitations: FDA reviewers and independent experts are scrutinizing the trial data. Across two major studies (PATHFINDER 2 in the U.S. and NHS-Galleri in the U.K.), the test demonstrated very high specificity (over 99.7%, meaning few false positives), but an overall 12-month sensitivity of only about 31% to 35%. This means it failed to detect nearly two-thirds of cancers diagnosed within a year of testing.

• Key debate points: The primary concerns revolve around whether the test can reliably catch cancers early enough to actually reduce cancer-related deaths, and whether the trial endpoints justify marketing it specifically as an “early detection” tool. Regulators and clinicians are also focused on labeling caveats so patients do not treat a negative result as a guarantee they are cancer-free, or forgo routine standard screenings like mammograms or colonoscopies.