Grail multi-cancer test taps into Hims & Hers network

Shortly after filing for formal FDA approval of its Galleri blood test for cancer screening, Grail has teamed up with telehealth company Hims & Hers to enhance its commercial availability.

Galleri is a multi-cancer early detection (MCED) or 'liquid biopsy' test that Grail says can spot signs of up to 50 different types of cancer in the early stages, including some without recommended screening tests available, when patients are more likely to respond to treatment.

Galleri works by detecting chemical changes in fragments of cell-free DNA (cfDNA) that leak from tumours into the bloodstream and was awarded breakthrough status by the FDA in 2018.

Now, Hims & Hers customers who have the company's Labs plan – which covers direct-to-consumer (DTC), app-based diagnostic testing service for health monitoring – can access the Galleri test with a $250 discount to its list price of $949.

Grail's president, Josh Ofman, said Hims & Hers is "a natural partner to offer the Galleri test" due to its prominent position in the digital health market, which will "enable this breakthrough technology to be available to more people."

At the end of last month, Grail filed a premarket approval (PMA) application with the FDA based on interim results of the US-based PATHFINDER 2 study and data from the NHS-Galleri trial in the UK, representing a dataset of more than 25,000 people, which used an earlier version of the test.

Grail has also submitted data from bridging analyses to show equivalence between the original and updated versions, and has said it expects full data from 35,000 PATHFINDER 2 subjects and 140,000 individuals in the NHS-Galleri study later this year. It is also enrolling another 50,000-patient study – REACH – in collaboration with Medicare in the US.

In PATHFINDER 2, people aged over 50 with no clinical suspicion of having cancer had a Galleri test added to standard-of-care screening for a single type of cancer, such as colonoscopies or medical imaging.

The results were presented at last year's ESMO cancer congress and showed that Galleri detected a cancer signal in 216 participants, which resulted in a positive cancer diagnosis with subsequent follow-up in 133 people. More than half (53.5%) of the detected cases were early-stage, and the MCED was able to identify the source of the cancer 92% of the time.

Direct sales of Galleri, with a prescription, have already resulted in more than 475,000 commercial sales, and Grail has said 2025 revenues are likely to be in the region of $148 million, driven by volume growth of more than 35%.

The partnership with Hims & Hers is expected to set up another strong year for the company in the US as it looks towards expansion in international markets.

"Even though cancer screening technology has advanced significantly, there are still too many life-changing diagnoses that should have been made earlier," said Hims & Hers' chief executive Andrew Dudum.

"Access to innovation is the key to changing that," he added. "Our platform brings together the best the healthcare industry has to offer in order to close the access gap."

California-based Grail was formerly part of DNA sequencing giant Illumina, which bought the company for $7.1 billion in 2020, but was divested in 2024 after the takeover was challenged by antitrust regulators.