- A new blood test could revolutionize cancer treatment, identifying malignancies earlier than ever
- In Michigan, at least one Michigan insurer and one hospital is making the Galleri test available
- But the test, which costs about $950, triggers uncomfortable questions, including: What is a human life worth?
Its promise is extraordinary: A simple blood test that identifies cancers at their earliest stage — long before symptoms or a mammogram or prostate exam detect a problem.
It could reveal dozens of other cancers for which there is no screen at all — ovarian, pancreatic and liver to name a few — giving clinicians a possibly lifesaving head start on treatment.
“Who wouldn’t want that test?” said Leonard Fleck, a medical ethicist at Michigan State University, whose specialty can lead to uncomfortable conversations about medical rationing and the value of human life.
In short, if it delivers on its promise — and there is some question about whether it can — the Galleri blood test could be what one company representative in 2022 called a “new front on the war against cancer.”
But there’s a catch.
That single blood draw costs $950 out of pocket, but it could cost the more than $5.3 trillion US health care system another $55 billion a year if it were made available to everyone under Medicare, Fleck estimates.
Those calculations make the Galleri test an example of how new technology — no matter how big the promise to save lives — must also be measured in dollars. It’s an unsettling, but necessary, cost-benefit analysis at a time when health care costs surge, medical debt hobbles households, and Michiganders shed health insurance they can no longer afford.
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“There’s all kinds of things we can do that might save some lives, and the cost at an individual level might be relatively small,” Fleck said.
“But if you’re doing it over tens of millions of individuals, you get very large numbers, and you get very small payback in terms of lives or life years that are saved.”
Large-scale national spending on the Galleri test — at least without clear evidence that it really will save lives — is “socially unaffordable,” Fleck has argued.
Yet a new federal law would extend coverage to at least some Medicare beneficiaries starting in 2028, if the US Food and Drug Administration approves the test. (An FDA committee is scheduled to meet to discuss Galleri’s effectiveness and safety Sept. 23.)
The effort had bipartisan support. Michigan’s US senators, Elissa Slotkin and Gary Peters co-sponsored initial legislation in the Senate, and 11 Congress members from Michigan co-sponsored a similar House bill.
Grail, the California company that makes the test, recommends everyone over 50 be screened with it each year – increased access that would cost $100 billion a year, Fleck estimates.
Dollars and lives
What is very clear is that cancer is costly both in terms of lives and dollars.
As it stands now, more than 1 in 3 people will get cancer eventually, and the disease is expected to kill more than 21,000 Michiganders this year, according to estimates by the American Cancer Society.
Moreover, cancer accounts for 7% of total US health care spending, according to KFF, a nonprofit focused on health care research.
And it’s most deadly and costly in later stages.
The first year of cancer diagnosis costs about $45,063, according to a study published last month in the Journal of the National Cancer Institute. End-of-life cancer care costs more than 2 ½ times that — about $121,746 each year, study authors estimated.
The surging cost of new cancer drugs will drive the cost of medical care in the US from $99 billion in 2023 to a jaw-dropping $180 billion by 2028, according to a study in the peer-reviewed oncology journal by Nature.
Earlier detection
Meanwhile, Americans are routinely screened for just five cancers — breast, cervical, colorectal, prostate and lung. That leaves the lion’s share of cancers without any routine tests.
The Galleri test, and Cancerguard, a similar test that Exact Sciences introduced last year, detect DNA fragments — a genetic fingerprint, of sorts — from cells that tumors shed as they grow.
Cancer detection now often relies on imaging, said Dr. Eric Klein, a scientist with Grail.
“The cancer has to be large enough to see,” he said.
Early detection means more effective treatment and better quality of life as patients avoid pain, disfiguration and other results of late-stage cancer detection, he said.
(Grail insists the Galleri test would supplement, not replace, screenings such as mammograms and prostate exams.)
Arguably the biggest promise in early detection tests is the lives they would save: 24,000 a year in the US, according to Grail.
“The selling point is that this is a non-invasive way to detect cancers early, and some for which there is no screening,” said Dr. Elena Stoffel, a spokesperson for the American Cancer Society, whose focus at Michigan Medicine is in cancer genetics and cancer prevention.
Moreover, in more than 9 in 10 cases, the test can signal where the cancer resides, Grail says.
Henry Ford Health began offering Galleri to patients in 2022 — the first Michigan hospital to do so. Patients have to pay out of pocket, since insurance doesn’t cover the test.
And last month, Grand Rapids-based Priority Health, Michigan’s second-largest health plan, announced that it would offer the Galleri test as an option to employers with self-funded insurance pools. Those employers can add the test to their plan benefits.
How much value, a human life?
According to Galleri, about 1 in 100 people who take the test will get a positive result, indicating that the test has detected a “cancer signal.”
But within those results are false positives, triggering costly follow-up testing and immeasurable stress to rule out cancer.
Even among those whose results are positive, many of the cancers would have been ultimately detected in some other way, and some would have been terminal no matter what stage they were detected, Fleck said.
Moreover, it’s unclear whether liquid biopsies like the Galleri test “overdiagnose,” detecting early cancers that a person’s immune system would seek out and destroy anyway, said Stoffel at U-M.
Given the uncertainty, Fleck pondered in his paper whether the tests such as Galleri are “low-value care” — a phrase that also has been gaining more attention as Americans increasingly are crushed by the weight of health care.
The US spends nearly $340 billion per year on low-value care which is costly on its own, but also can lead to “costly cascades of additional, unnecessary care,” according to the Center for Value-Based Insurance Design at the University of Michigan.
The most glaring uncertainty is this, she said: Does early detection by Galleri really result in longer lives?
‘Worth it’
A recent patient consulted Dr. Najeeb Al Hallak, oncologist at the Barbara Ann Karmanos Cancer Institute after other tests failed to detect cancer cells.
The man, in his early 40s, had a family history of cancer. Uneasy, he consulted Al Hallak, who recommended the Galleri test.
The blood test flagged a “positive” result for colon cancer, and a follow-up PET scan found the early-stage cancer in the patient’s small intestine.
The cells were surgically removed, saving the man from chemotherapy, Al Hallak said.
So is the test worth the cost?
“He will say it’s worth it because we found the cancer,” Al Hallak said of his patient.
But anecdotes can be misleading, Al Hallak said.
It’s unclear what happens when the test is given to millions of patients each year, most of whom will get a “negative” reading, including those for whom the test misses a cancer, he said.
Even Klein, the Grail scientist, acknowledges that it will take another several years to know whether the test’s early detection really extends lives.
As a long-time cancer doctor whose patients include those who are at high risk for cancer, Stoffel at Michigan Medicine hasn’t yet prescribed a single Galleri test.
“The question is do we really see an improvement” in the larger population? she asked. “Do people live longer, better lives? The jury’s still out.”
Klein, the Grail scientist, is also a cancer doctor.
“We are not going to make a dent in cancer without early detection — that’s very clear from every study,” he said.
Certainly, making cancer screening more accessible is a policy decision, Klein said, agreeing with Fleck.
“But I would ask him ‘What problems are more important than addressing that?” he said. “And are we going to look those 600,000 people in the face and say ‘Your life’s not worth it?’”
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