By Anita Hamilton

A new Super Bowl ad from Hims & Hers is giving some medical experts pause. In addition to touting the company's weight loss drugs and testosterone treatments, it promotes a controversial early cancer detection test.

Hims & Hers charges $689 for the test, which involves a blood draw and a prescription by a medical professional. It isn't approved by the Food and Drug Administration, nor is it covered by Medicare and most health insurance plans. However, the test's manufacturer, Grail, recently applied for premarket approval for it from the FDA and new federal legislation creates a pathway for Medicare coverage.

The test, known as the Galleri multi-cancer early detection (MCED) test, promises to detect up to 50 different cancers before symptoms appear. Exact Sciences, maker of the colon cancer screening test Cologuard, released a competing product called Cancerguard last fall for $89, while Cancer Check Labs offers one that screens for some 200 kinds of cancers for $1,995.

Despite the growing number of options, many medical experts are tamping down consumer expectations for the tests. "We do not yet know if these tests reduce mortality," says Dr. Carmen Guerra, a primary care physician at the University of Pennsylvania and cancer control researcher.

Only three cancer screening tests -- breast, colorectal, and cervical -- are currently widely recommended. A fourth, for lung cancer, is only recommended for smokers. While that leaves a whopping 70% of other cancers not regularly screened for, evidence showing the current crop of MCED tests are effective is lacking.

"They don't have the data to support them," says Dr. Elizabeth O'Donnell, director of Dana-Farber Cancer Institute's Multi-Cancer Early Detection Clinic. "These are not replacements for current screening tests."

O'Donnell added that Grail's test is still being studied and is promising. "Think of it like the iPhone one, maybe it's the BlackBerry, we don't know."

Scientist Eric Topol has criticized the Grail test offered by Hims & Hers after early findings from a study last fall found a high number of false negatives.

"I would not recommend a Galleri test the way it is getting done today," specifically, for those aged 50 or older, he wrote. "But in a bona fide high-risk individual that may deserve consideration, and increasingly so as these MCED tests continue to improve."

Hims & Hers declined a request to comment, instead referring Barron's to test maker Grail. The company didn't immediately reply to a request for comment.

Grail's stock has risen 17% this year on growing interest in its test, but Hims & Hers is down 29%, largely on worries the FDA may crack down on its copycat version of weight-loss drug Wegovy.

Write to Anita Hamilton at anita.hamilton@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

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February 06, 2026 17:41 ET (22:41 GMT)

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