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Galleri’s blood test screens for 50+ cancers with 99.5% specificity, reducing need for invasive biopsies and enabling earlier detection.
AUSTIN, TX, UNITED STATES, August 11, 2025 /EINPresswire.com/ — The Galleri test can screen for over 50 types of cancer with a single blood test, helping patients to avoid multiple biopsy procedures to take tissue samples during the cancer diagnosis.
The Galleri test detects cancer by identifying unique DNA “fingerprints” from tumor cell fragments. About 1% of adults aged 50–79 receive a Cancer Signal Detected result, which also indicates the likely Cancer Signal Origin (CSO). Following further diagnostics, roughly 40% of these cases are confirmed as cancer.
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The Galleri test demonstrates 99.5% specificity with a false positive rate of less than 1%, making it highly reliable for early cancer detection. It screens for several of the deadliest cancers, including pancreatic, esophageal, ovarian, and liver cancers. Validated across over 140 clinical study sites, the test is supported by an extensive clinical development program expected to include more than 380,000 participants.
How the Galleri Test Works
Galleri is a prescription-only multi-cancer early detection test that analyzes a blood sample to detect cancer signals and predict their origin. If a signal is found, healthcare providers guide the next steps, which may include reviewing medical history, conducting physical exams, and performing guideline-based evaluations such as lab tests and imaging. Identifying the likely origin of the cancer is crucial for determining the most appropriate diagnostic pathway.
According to DataM Intelligence: The global multi cancer early detection testing market reached US$ 1.67 billion in 2023, with a rise of US$ 1.92 billion in 2024, and is expected to reach US$ 7.52 billion by 2033, growing at a CAGR of 16.5% during the forecast period 2025-2033.
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Recent Developments:
In June 2025, GRAIL, Inc., a healthcare company focused on early cancer detection, has reported positive results from its registrational PATHFINDER 2 study, which analyzed the safety and performance of the Galleri® multi-cancer early detection test in 35,878 adults over 50 years of age with no clinical suspicion of cancer. The study aimed to evaluate the test’s effectiveness in enhancing standard of care single cancer screening.
In December 2024, Function Health, a lab tests startup, has partnered with GRAIL (ILMN) to offer early cancer detection tests to its members. Launched in 2023, the company offers over 100 lab tests to assess heart, liver, kidney, thyroid, nutrients, and stress health.
Major Companies: Major companies operating in the market includes GRAIL, Guardant Health, Exact Sciences, Burning Rock Biotech, Lucence Health, Foundation Medicine (Roche), AnchorDx, Freenome, and Niramai.
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Author: Gundreddy Gopinadh is a healthcare research analyst with over a decade of experience in medical devices, pharmaceuticals, biotechnology, and in-vitro diagnostics (IVD). He specializes in delivering actionable insights through custom market research projects, helping organizations analyze trends, assess competitive landscapes, and uncover growth opportunities. His expertise has guided healthcare companies in product development, strategic planning, and market expansion, positioning him as a trusted contributor to data-driven innovation in the global healthcare industry.
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