Hims, other telehealth platforms push multi-cancer detection tests before evidence of benefit

STAT News – Friday, February 6, 2026
By Katie Palmer

A father pulls up in his car, waiting to pick up his kid. As he sits in the driver’s seat, he opens his phone. He smiles, and throws his head back with relief: “No cancer signal detected,” he reads, just as his son climbs in.

This scene appears in a Super Bowl ad that telehealth company Hims & Hers will run this weekend. Last year, Hims ran a controversial game-time clip promoting the company’s weight loss medications to more than 100 million viewers. This time, it’s using part of its minute-long slot to market one of its latest offerings: a multi-cancer early detection test called Galleri.

Grail, the test’s developer, has faced many hurdles as it has worked to validate and market its blood-based test for detecting dozens of tumor types. Galleri and several competing multi-cancer tests have not been approved by the Food and Drug Administration, but their companies are able to market them as lab-developed tests — and increasingly, they have relied on telehealth platforms like Hims to prescribe their products to patients.

As the virtual marketing for multi-cancer early detection tests expands, test makers and telehealth providers say they want to give more people a chance to catch cancers before symptoms emerge and seek treatment. But some cancer and health policy experts are concerned that broad promotion of the tests before concrete evidence of benefit could harm patients, especially if telehealth platforms favor a consumerist approach to medicine.

That fictional father’s relief at his negative test result is misleading, said Ruth Etzioni, a biostatistician who studies cancer screening at the Fred Hutchinson Cancer Center. “How dare you put out an ad that shows somebody being relieved when their test is negative, when we know for sure that that’s not reliable with this test,” she said. “We are really worried that people who get negative results will actually end up hurting themselves by neglecting aspects of their health that they should not be.”

Companies have lobbied extensively for multi-cancer tests to be covered by Medicare, and on Tuesday, the spending package signed by President Trump included a provision that will allow for Medicare coverage after FDA approval and starting in 2029. Until insurers decide to pay, telehealth offers an easy way to reach patients nationwide who want to pay cash for the tests, which cost between $700 and $950.

“We know that there’s large populations over the age of 35 and over the age 50 who are at elevated risk for cancer in these telemedicine platforms,” said Grail President Josh Ofman. “We see that that’s a fast-growing segment, and a lot of consumers want to take control of their health and be able to pick and choose what they want to do.”

Galleri saw its year-over-year sales grow 29% in the third quarter of 2025 to $32.8 million. Investors, hoping that FDA approval and Medicare reimbursement could drive bigger sales, have bid Grail’s shares up 250% over the past 12 months, and the company submitted Galleri for FDA approval in January.

Usually, new technologies are slowly introduced by doctors and only marketed to patients once they are approved by the FDA. But some companies see the booming digital health market as a way to supercharge the sales of multi-cancer detection tests.

Along with Exact Sciences, the developer of the Cancerguard multi-cancer test that launched in September, Grail enables telehealth onboarding for patients who visit its branded site: Potential patients can click a button to “request a test” at no additional cost, routing them to telehealth partner Recuro Health to issue a prescription if appropriate.

Several other direct-to-consumer telehealth companies also offer the tests, and Grail has partnered with digital health companies Function Health and Everlywell to offer Galleri. Hims, which invested in Grail in October and started prescribing Galleri on Wednesday, is the largest and best-known telehealth brand to offer the test, having grown in less than a decade into a public company valued at more than $5 billion.

Tested negative? Doesn’t mean no cancer

Multi-cancer early detection tests are part of a larger class of liquid biopsies, tests that detect cancer by looking for tumor byproducts like DNA fragments in blood. They can find signs of more than 50 cancers, including many that aren’t part of standard screenings for breast, colon, cervical, lung, and prostate cancer.

The hope is that these tests will catch cancers early enough that intervention can save lives. But cancer and public health experts have said the tests, which are not recommended by any professional medical society, are being rolled out ahead of the evidence.

If a patient gets a positive test result, it’s often right. In Grail’s recently released results from a study of nearly 36,000 adults over age 50, nearly 62% of patients who received a positive result were found to actually have cancer. When that happens, Ofman said, patients should “go talk to your doctor about this immediately.”

But negative results aren’t as meaningful for patients. “The sensitivity of these tests is fairly poor,” said Scott Ramsey, a cancer researcher at the Fred Hutchinson Cancer Center. In the same study, Galleri caught 40% of cancer cases — meaning that the test missed more cancers than it detected.

Etzioni and other cancer and health policy experts worry that patients using multi-cancer tests will be left with false reassurance, and that the scale provided by telehealth platforms compounds that risk.

“I’m concerned that on a big platform, people could go out and get the tests and the vast majority of them will be negative,” said Etzioni, who is leading a randomized trial of two multi-cancer detection tests in the United States with Ramsey. “And they’ll say, ‘Oh, I’m doing great. I don’t have to get my other tests that I really should get.’” Trading regular screenings for cash-pay lab offerings and telehealth services could become more common as more Americans lose health insurance coverage or struggle with high-cost plans.

Hims & Hers Chief Medical Officer Pat Carroll acknowledged the concern over test sensitivity, but said customers shouldn’t be “reassured that, ‘Oh gosh, nothing showed up on my Galleri test, that means I don’t need to get my colonoscopy if I’m over age 50,’” said Carroll. “That’s not our intent.”

Ofman said Grail’s internal data has shown Galleri users also tend to be diligent about getting their standard cancer screenings, research it plans to publish this year. “We find that very reassuring, but we don’t take the foot off the gas,” he said. “We spend a lot of our effort educating doctors, and I hope the doctors are educating their patients about what a negative test result really means.”
Tested positive? You get more tests

A positive result on a multi-cancer early detection test is just the beginning of the road for patients. They will require diagnostic exams and imaging, possibly followed by biopsies, to determine if cancer is present.

If a telehealth company prescribed the test, patients will have to go to their primary care provider to start the process, or talk to one of the testing companies’ care navigators. Because of the complexity of that handoff, Guardant Health said its new nine-cancer screening isn’t available through telehealth.

These follow-ups incur stress, cost, and potential harm, so experts have warned against screenings that haven’t been proven to improve health outcomes. That doesn’t mean simply catching cancer earlier, but catching the right cancers: ones that would actually progress and cause symptoms, and those with treatments that would delay those symptoms and extend a patient’s life.

For multi-cancer tests, physicians still don’t have that evidence. An ongoing clinical trial of Galleri in the United Kingdom could help provide some answers, and cancer researchers are hopeful that results will help guide the test’s use for patients, especially those with family histories or environmental exposures that put them at higher risk.

A positive test can be trusted more by higher-risk patients, and so far, multi-cancer tests like Galleri have been targeted at those adults — a point Ofman said it’s been very clear about with its telehealth partners. “But doctors and providers have to be able to use their discretion about who they believe is an adult at an elevated risk for cancer,” he said.

At Hims & Hers, Carroll said that adults who are not at elevated risk of cancer could get a Galleri prescription, barring obvious rule-outs like a recent cancer diagnosis. “You don’t have to be aged 55 or 50 to get the Galleri test. You don’t have to have a strong family history of cancer to get the Galleri test,” he said. “We want our customers to make an informed decision: This is what the test is, this is what it shows, this what it doesn’t show. It’s not diagnostic, it’s screening. But we’re very pro-customer choice, and so we’re giving the customers a choice on that.”

Offering the tests to lower-risk patients would, among those who test positive, lead to more unnecessary diagnostic odysseys than if they were limited to high-risk patients, said Sanket Dhruva, a cardiologist and health policy researcher at the University of California San Francisco.

“Some of them will still undergo workups that do not result in cancer diagnoses. They will have radiation from a PET CT scan that doesn’t show anything. Some will undergo invasive procedures like biopsies that turn up nothing,” said Dhruva. “Some of the people will be harmed.” And they or their health insurance will be on the hook for those follow-up expenses, potentially driving up health care costs across the board.

The same dynamic is true of single-cancer screenings, Ofman emphasized, adding that multi-cancer early detection tests are less likely than many of those standard screenings to give a false positive.

“Is it a perfect test? No. Do we have a perfect health system? Absolutely not. Does this add value? We are entirely convinced that it does,” said Carroll.

While some researchers and clinicians aren’t convinced, they are enthusiastic about the future of cancer screening with liquid biopsies. Multi-cancer detection tests have improved their performance steadily over years of development, and newer biological approaches could drive it even higher.

“These tests can do good,” said Etzioni. But she also finds it premature to be marketing them to the public. “It’s going to be very hard for the consumer to figure out what’s going to be best for them, because they will be dealing with all of this marketing,” she said.

Hims’s Super Bowl ad starts with a declaration: “Rich people live longer. All that money doesn’t just buy more stuff, it buys more time,” narrates rapper and actor Common, as the ad lists health options available to those with money. “They get the best of everything. So why don’t you?”

In fine print at the bottom of the ad and in its press release announcing Galleri’s availability, Hims acknowledges the test’s limitations: Galleri is not FDA-approved. It doesn’t diagnose cancer. It shouldn’t replace standard cancer screenings. False positives and false negatives happen.

“There’s a pretty big disconnect here,” said Ramsey. “They’re marketing these tests as ways to live longer. And that by itself is a fundamentally unproven statement.”

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