A while back I wrote about Galleri, the holy grail of cancer screening tests, saying:
Cancer is usually treatable if caught early. The cancers that are the deadliest (such as pancreatic cancer) are lethal because they are difficult to catch early. Many deadly cancers have no symptoms until they’ve spread. About 90% of cancer deaths are due to metastatic cancer, that is cancer that has spread beyond the original location. In theory most cancer could be treatable if only it could be caught sooner, before it has a chance to spread.
Kaiser Health News recently reported on the test, using a feel-good anecdote about a rap music artist with a family history of cancer.
But Milam was haunted by a family history of cancer, including his mother’s death from stomach cancer at 54. So, at age 37, he told his physician in San Francisco that he wanted to take every precaution against being diagnosed too late to live a full life. As it happened, his doctor said there was a new test to try.
The blood test, Galleri, returned a DNA signal for colon cancer. After a colonoscopy confirmed it was stage 3, Milam underwent eight hours of surgery, followed by radiation and chemotherapy. Today, he said, he is cancer-free.
Galleri costs $949 and most health plans do not pay for it. However, it sounds like something that millions of Americans may want (especially if they could get someone else to pay for it).
Grail, the Menlo Park-based biotech company that created Galleri, says it checks more than a million specific DNA sites for cancer signals and can identify more than 50 types of cancer, including cervical, colon, breast, and prostate.
Kaiser goes on to say the multi-cancer early-detection (MCED) tests are controversial. Why would a test to screen for the DNA of 50 different cancers be controversial? Because the company did not seek the blessing of public health advocates, showing it saves lives, extends lives and because it’s supposedly wasting resources on healthy people.
“A screening test has to be magnificent, mathematically, for it to be beneficial,” said Jerome Hoffman, a professor emeritus at UCLA’s Department of Medicine and a longtime critic of overtesting and overdiagnosis. “The biggest threat on the horizon is overdiagnosis — finding things that don’t matter but that we intervene on anyway.”
Another reason that experts are skeptical is because Grail used a loophole of sorts to bring their test to market.
Grail used an exemption for laboratory-developed tests to begin marketing Galleri without FDA approval two years ago, a move that raised eyebrows in the medical community because that process is typically used for tests with no commercial value.
Public health experts would like a 10-to-15 year study illustrating the risks of false positives, false negatives and the cost per life year saved. For instance, patients being told they have cancer when they don’t could lead to unnecessary interventions, not to mention unnecessary worry. Being told they don’t have cancer when they do could be much worse. All preventative medical screenings have a cost per life year saved. That means how many people must be screened to save a life and how many years of life are saved. That figure is divided by the total cost of screenings. The cost per life year saved is probably in the millions, but peace of mind is worth something too.
I tend to think tests like Galleri have merit since many people have a family history of cancer and cancer is a disease of old age. The youngest of 70+ million Baby Boomers turn 60 in 2024. The increase in cancer deaths in the 20th century has a lot to do with people living long enough to get cancer. However, since tests like Galleri are done on healthy people, it’s not a medical necessity.
The tests that are required to be covered by health plans are those recommended by the U.S. Preventive Services Task Force. For instance, mammography every other year on women age 40 to 74 is a recommendation. A DNA test for numerous cancers does not fall into that category because it hasn’t been evaluated by the Task Force, or the cost per life year is too high. Despite the lack of recommendation, the company (of course) wants health plans to pay for it:
Josh Ofman, Grail’s president, said the company is lobbying Congress “along with many constituent groups” to authorize Medicare to cover the cost of MCED tests, which could unlock billions of federal dollars in potential revenue. Grail recommends annual screening, but it’s generally not covered by insurers.
The Galleri test sounds impressive, but it is a consumer good that should be paid with consumer funds, not something your health plan should have to fund. At the right price a lot of people would be willing to spring for the money.