ARTICLE SUMMARY:
In September, a high-profile FDA advisory committee panel recommended regulatory approval of GRAIL’s multi-cancer early detection screening test, paving the way for a new paradigm in diagnostics. Wall Street and companies working on MCEDs responded favorably, and GRAIL’s stock jumped. The panel opinion has nuances, however, and the next steps will be critical in sorting out an opportunity that is guaranteed to be complicated, as well as exciting.
Investors certainly cheered following a favorable FDA advisory committee panel review on September 23 of GRAIL’s pioneering and controversial multi-cancer early detection (MCED) Galleri test.
GRAIL’s stock jumped a hefty 34% as soon as the FDA briefing documents were published on September 21, and it continues to climb steadily.
The panel (formally known as Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee) recommended approval of the test as a screening device for adults aged 50 years or older, as well as criteria for FDA to evaluate it. Its conclusions have alleviated substantial uncertainty surrounding a new, extremely controversial field of diagnostics, which is arousing the interest of clinicians and many patients, and attracting billions of dollars of investment. Panel members acknowledged this milestone as a major step in the multiyear process of making MCEDs mainstream and accessible.
They emphasized the advantages of the test’s high specificity, low false-positive rates, and accurate cancer signal of origin (CSO), potentially establishing these as benchmarks for the category. The upshot is, in lay terms, the test produces relatively few false alarms and reasonably credible positives yet misses most cancer cases.
Nuances, however, are critical in diagnostics, particularly when it comes to screening tests, and the 10-member panel raised concerns that will resonate as Galleri and follow-on tests wind their way through the regulatory and reimbursement process and come on the market. Importantly, the reviewers questioned GRAIL’s use of the term “early” in describing the test detection capabilities and were concerned about how its complexities will be communicated and integrated into the healthcare system.
