A Bay Area-based company that sells an innovative blood test just released the results of a major clinical trial. 

A Silicon Valley-based company’s innovative blood test, designed to identify cancer early, hit the market five years ago and even cameoed in a recent Super Bowl ad.  

But new results from a large clinical trial revealed that the blood test did not significantly reduce advanced cancer diagnoses, the maker Grail announced on Thursday. 

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Although Grail highlighted silver linings in the trial findings, the company’s stock cratered by 50% on Friday. 

“As the stock market reacted, I think those results are not sufficiently impressive to be transformative,” Ash Alizadeh, a researcher who leads the Stanford Cancer Institute’s cancer genomics program, told SFGATE. “It kind of breaks my heart to see the study be negative.”

Grail has sold its blood test, called Galleri, in the U.S. for just under $1,000 since 2021. The Food and Drug Administration has yet to approve it, however. Doctors can order the technology under the Clinical Laboratory Improvement Act regulations. 

A Grail employee picks up a blood vial for testing.

In collaboration with the National Health Service of Britain, Grail launched the clinical trial the same year it started selling the product. About 142,000 people in Britain, ages 50 to 77, joined the trial, which involved annual blood tests for three years. 

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Despite some cancer researchers publicly expressing disappointment in the results of the trial, Grail executives argued the test still has benefits. 

In the clinical trial, the goal of using the blood test was to improve detection of more than 50 cancers at Stages 1 or 2 — with the set target of a 20% reduction in Stage 3 and 4 cancer diagnoses compared with routine screening. Although the trial missed that target across all cancers, it found that for a subset of 12 cancer types, Stage 4 cancer diagnoses decreased and Stage 3 cancer diagnoses increased. That suggests potential earlier detection of tumors. 

“We are excited to see the substantial reduction in Stage IV cancer diagnoses, as well as the continued strong Galleri test performance metrics,” Bob Ragusa, Grail’s CEO, said in a statement. “Based on these promising data, as well as the exciting PATHFINDER 2 results, we are expanding our field-based sales and medical teams to bolster our education efforts and support growing demand.”

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Notably, there were “no serious safety concerns” for participants in the trial, Grail said. 

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But the American Cancer Society stresses that these tests — which search in the blood for cancer DNA — need to be studied further before recommending them for widespread use. “Even if they are approved at some point, MCD tests do not replace current screening tests, such as mammograms for breast cancer, Pap tests and HPV tests for cervical cancer, stool tests and colonoscopy for colorectal cancer,” the society advises. 

Alizadeh described what could be a deeper issue with the technology. 

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“This study focused on whether they could detect more of the cancers at early stages than late stages,” he said. “But many of us argue that’s still not good enough. You have to show that you improve survival, because just moving the stage doesn’t necessarily mean you improve outcomes.”

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