Grail's Cancer Blood Test Nears Approval, Paving Way for Potential $60 Billion Market
An advisory panel to the US Food and Drug Administration has recommended approval for Grail's Galleri blood test, which detects early cancer signals in a single sample. The test can identify more than 50 types of cancer and pinpoint their likely origin with 93.4% accuracy. While FDA approval is not required, analysts expect it will be granted soon.
The test's potential benefits far outweigh its risks, according to the panel. However, there are concerns about follow-up costs and uncertain benefits. A three-year UK trial found Galleri did not significantly increase early cancer detection or reduce late-stage diagnoses compared with standard care. But full trial results showed a 26% reduction in stage IV diagnoses across 12 deadly cancers by the third round of screening.
Grail's CEO highlighted the test's potential at an industry conference, citing its benefits for patients and policymakers alike. The Make America Healthy Again movement, associated with Health Secretary Robert F. Kennedy Jr., also supports the tests. US health insurers CVS and Humana declined to comment on their coverage plans, while UnitedHealth, Cigna, and Centene did not respond.
Widespread insurance coverage could create a $60 billion-a-year US market by 2030, based on 120 million adults aged 50 and older taking a $500 test annually. Globally, the market could reach $150 billion, with the US market at $18 billion to $30 billion.