On Wednesday, Sept. 23, an outside advisory committee to the Food and Drug Administration sits down with a blood test that’s been a decade in the making — and that, if the Journal’s editorial board is right, could change what a routine checkup looks like. The test is Galleri, from Grail (GRAL). It reads DNA that cancers shed into the bloodstream, then uses genetic sequencing and machine learning to work out where the cancer started. The question in front of the panel is whether that’s proven enough.
The editorial board says it is, and its case rests on a randomized trial run with Britain’s National Health Service: about 142,000 people aged 50 to 77, half of them tested every year. By the board’s account, Galleri found four times as many cancers as the U.K.’s four standard screenings for colon, breast, lung and cervical cancer. Stage-one and stage-two diagnoses of the 12 deadliest cancers rose 16%. Stage-three diagnoses rose 25% while stage-four diagnoses fell 14%, and that stage-four decline grew the longer the trial ran — which the editorial reads as cancers being caught earlier.
What the critics want
Critics counter that total stage-three and stage-four diagnoses didn’t fall, and want trials showing the test reduces deaths before the FDA signs off. The board answers with survival math — five-year survival for colon cancer is 11% at stage four versus 64% at stage three; bladder, 6% versus 32%; stomach, 5% versus 25% — and argues that demanding mortality trials would delay approval by years. It puts former FDA biologics chief Vinay Prasad, who has said existing screenings cost too much, in that camp. A North American study of 36,000 people over 50, the board adds, found 6.5 times as many cancers as U.S. Preventive Services Task Force screenings; more than half were early-stage, and 73% were types with no recommended screening. Fewer than half of initial positives are false alarms, and 85% of follow-ups are non-invasive.
Here’s the part that touches your wallet today. Galleri is already available by prescription as a lab-developed test overseen by the Centers for Medicare and Medicaid Services. It costs $799 out of pocket, and Medicare and most insurers don’t cover it. Wednesday’s panel is a yes-or-no event for the company’s shareholders; for everyone else, it’s a reminder that the tests tend to arrive before the coverage does.
Our read
The science is a conversation for you and your doctor — talk to your doctor. The budget is ours. This is exactly the shape of cost retirement plans miss: not the premium, not the deductible, but the thing insurance doesn’t cover yet (M11). Medicare’s gaps are where the surprises live, and $799 a year for one test is a real line, not a rounding error.
Two practical moves. If you have a health savings account, this is what those tax-advantaged dollars were built for: a screening test your doctor prescribes is generally a qualified medical expense, and while Medicare enrollment ends new HSA contributions, the balance already there can still be spent tax-free. And put a line in the retirement budget labeled the tests insurance won’t cover yet, then fund it, because that list tends to grow. You don’t wait for the first drop to find the umbrella, and you don’t wait for the diagnosis to find the $799.