On April 9, Business Insider reported that Grail, a biotechnology company specializing in early cancer detection, has recently attracted widespread attention and doubts in the industry about the actual effectiveness of its blood testing product Galleri.Although the company claims that it can screen for more than 50 types of cancers with a single blood draw, in multiple large-scale real-world tests, the product has exposed serious problems of low early detection rate and high false negative rate, and its actual clinical value is facing severe tests.
Relying on the background of gene sequencing giant Illumina, Grail had high hopes from the capital market and was listed in 2024 with a valuation of US$500 million. It also formally applied for approval from the U.S. Food and Drug Administration (FDA) in January this year. Currently, a single Galleri test on the market costs about US$824 to US$950 (approximately RMB 5,630-6,500), which mainly locates lesions by detecting tumor DNA signals shed in the blood. However, in a 2021 laboratory study, the test's overall cancer detection rate was only 51.5%, and the detection rate for early stage 1 cancer was as low as 16.8%.
Grail founder Rick Klausner served as director of the National Cancer Institute
Real-world application data further heightened concerns. In a test conducted by the San Francisco Firefighters Cancer Prevention Foundation at a cost of more than $1 million, only 5 out of 1,786 firefighters tested were diagnosed with late-stage cancer, and all of the patients subsequently died.At the same time, there were 6 false positives in the system. What’s more serious is that at least 3 firefighters whose test results showed no abnormality were diagnosed with cancer within six months. The foundation has now publicly stated that it no longer supports the routine use of such multi-cancer early detection products due to potential harms such as false reassurance, missed diagnosis and unnecessary follow-up procedures.
Large-scale clinical trials around the world have also failed to meet expectations.In a preliminary trial involving 23,000 people in the United States and Canada, Galleri diagnosed 133 cases of cancer, but missed as many as 196 cases within a year and generated 83 unconfirmed false positive signals. In addition, Grail's 140,000-scale trial in partnership with the UK's National Health Service (NHS) failed to achieve its core goal of reducing the number of stage III and IV cancer diagnoses. This result directly caused Grail's share price to plummet 50% after the news was announced. Given the limitations of current data, the American Cancer Society currently does not recommend routine use by the public of such multi-cancer early detection (MCED) services.