By SPEAKIN’ OUT NEWS
A blood test designed to detect signals associated with more than 50 cancers is moving closer to a major federal review, but health officials emphasize that it should not replace established cancer screenings.
The Food and Drug Administration’s Molecular and Clinical Genetics Panel is scheduled to evaluate Grail Inc.’s Galleri test Sept. 23. The prescription-only test is intended for adults 50 and older who do not have signs or symptoms of cancer.
Galleri analyzes cell-free DNA in a patient’s blood for cancer-related methylation patterns. When the test detects a possible cancer signal, it also attempts to identify where that signal originated. A positive result must be followed by additional diagnostic testing from a qualified healthcare provider.
FDA staff reviewers raised no major unresolved concerns about the test’s analytical performance, study design or primary safety analysis, Reuters reported. However, advisers have been asked to determine whether the available evidence supports describing Galleri as an early-detection test.
That distinction is important. A three-year United Kingdom study found that routine screening with Galleri did not significantly increase early cancer detection or reduce late-stage diagnoses. Grail submitted its application using information from a smaller U.S. study, first-year findings from the British trial and an analysis comparing different versions of the test.
Galleri is already available under federal laboratory regulations but has not received FDA approval. Approval could expand distribution, influence medical guidelines and improve the possibility of insurance coverage.
Grail says the blood test is intended to complement—not replace—mammograms, colonoscopies, prostate evaluations and other recommended screenings. Patients should discuss potential benefits, limitations and follow-up costs with their physicians before ordering any multi-cancer screening test.