🇺🇸—“Hims & Hers” is promoting a new product to the massive NFL audience. A cutting-edge blood test designed to detect more than 50 types of cancer before symptoms show up. But the test’s reliability is questionable, with its manufacturer cautioning that it should be followed by additional medical procedures to diagnose cancer.

The ad features a man pulling out his phone as he waits in a car, checking a screen that reads “No cancer signal detected.” He smiles and closes his eyes in an expression of relief. That portrayal raises what some experts say is a risk of giving patients a false sense of security.

A large clinical trial showed that the test, called Galleri and based on a single blood draw, is not always reliable, especially on its own. It missed more cases of cancer than it found, according to Eric Topol, director of Scripps Research Translational Institute, who analyzed the trial results on his Substack in October.

The test works by scanning for tiny DNA fragments, shed by cancer cells, that float in the blood, and it can pinpoint the specific organ or tissue where the cancer signal originates. Hims & Hers will make the prenoscription test available for consumers who subscribe to its $350 lab testing service — but it will cost an additional $700, the company said, a roughly 25 percent discount from the manufacturer’s list price.

The test makes a prediction, not a diagnosis. In a clinical trial of more than 23,000 participants who were not suspected of having cancer, Galleri rarely found a cancer signal, according to results that Grail posted in October. Of the 216 participants flagged by Galleri, about 60 percent were diagnosed with cancer within 12 months. That was a better predictive rate than in a previous trial, but it still meant that the test’s positive cancer signal did not result in a cancer diagnosis about 40 percent of the time.

Though the test is made in a federally certified lab, Galleri — like many tests on the market, hasn’t been cleared by the FDA as safe and effective. Grail is seeking to expand access by winning the agency’s blessing, which is typically a prerequisite to getting large insurers to cover a test.

🇺🇸—Epstein survivors are releasing this ad on Super Bowl Sunday.

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