An advisory panel to the US Food and Drug Administration handed Grail’s Galleri blood test a milestone win, saying the early cancer detection test’s potential benefits outweigh its risks and bringing it a step closer to approval.
The FDA need not adhere to the panel’s recommendations, although it generally does, and Wall Street analysts are predicting that the agency will be granting approval to Grail in the near future.
The Insurance Coverage Hurdle and Out-of-Pocket Costs
If approved, it would take Grail and other tests to what analysts consider the next big hurdle – becoming an approved health insurance test in the United States.
There is no FDA-approved test, and most private insurance plans and government health care programs, such as Medicare, don’t cover these tests. Galleri and Abbott’s CancerGuard are sold in the USA as laboratory-developed tests under the Clinical Laboratory Improvement Act. Medicare does not cover them, so patients would have to cover approximately $700 and $900, respectively, out of pocket.
If FDA approves the tests, they will become eligible for Medicare coverage in 2028 under a new US law passed this year. Even if the US Preventive Services Task Force recommends their use, private insurers would likely have to cover them. CVS and Humana, both health insurance providers and rivals, did not comment on their coverage plans. UnitedHealth, Cigna and Centene did not respond to requests for comment.
Market Growth and Projected Revenue
By 2030, a US market could be $60 billion a year, and that’s assuming 120 million adults older than 50 take a $500 test each year, Gabelli Funds portfolio manager and research analyst Elena Meng said.
The market is projected to grow to $150 billion worldwide, Meng added. She believes the U.S. market would reach $18 billion to $30 billion over five to 10 years, with 30% to 50% penetration.
Currently, there are only five types of cancer for which preventive screening guidelines exist in the United States: breast, cervical, colorectal, prostate, and lung. The screening tests are only performed for prostate cancer by blood test; for others by mammogram, Pap or HPV test, stool test, or low-dose CT scan.
SpotitEarly CEO Shlomi Madar said there’s a huge gap between that: “We have over 200 types of cancer and only 5 recommended screenings. Only 14 per cent are picked up during routine screening, he added.
How Multi-Cancer Early Detection Technology Works
The objective of multi-cancer early detection tests is to fill the gap in screening by identifying tumor markers in a single blood sample. The signals are fed into AI and machine-learning models, which work to identify a cancer “fingerprint” and determine the cancer’s origin, or tissue or organ of origin.
Galli’s cancer detection is expected to be accurate for over 50 types of cancer, and Galleri can identify where a cancer signal is coming from with 93.4% accuracy, Grail says. Negative does not necessarily exclude cancer, and a positive result does not necessarily mean that cancer is present.
However, there is debate among doctors and researchers about whether such tests give the physician enough useful information needed to improve patient outcomes.
Galleri did not significantly improve the early detection of cancer or lower the number of late-stage cancer diagnoses in a three-year UK trial of asymptomatic adults between the ages of 50 and 77, Galleri said earlier this year. In May, however, full trial results revealed a 26% drop in the number of stage 4 diagnoses across 12 deadly cancers at the third round of screening.
Grail’s CEO spoke about the benefits they could have at an industry conference in Washington on Tuesday, which also garnered the backing of the Make America Healthy Again movement led by Health Secretary Robert F. Kennedy Jr.
“No matter what our opportunities are, we’re happy to engage advocates, patients and policy makers who are looking to raise the profile of prevention and early detection of disease up to a national agenda,” said a company spokesperson.
Medical Concerns and Technical Challenges
However, scientists and physicians have expressed concerns about the emotional distress and cost to health that can accompany a positive test.
Blood-based assays for detecting early-stage cancers are technically difficult and biologically challenging because the early tumors release very little signal into the blood, said Aadel Chaudhuri, professor of radiation oncology at Mayo Clinic Comprehensive Cancer Center. If the test comes back positive, it can lead to expensive additional testing, he added.
None of the screening tests are foolproof, he said. In some instances, we need to recognize that we’re not setting the standard for these tests higher than we are for other diagnostic tests,” she said. Karthik Giridhar, an oncologist at Mayo Clinic and principal investigator of Grail’s Pathfinder 2 study, said FDA approval and insurance coverage could help bring more people in than those who can pay out of pocket.
Grail’s Galleri multi-cancer early detection test is approaching a major regulatory milestone after a U.S. Food and Drug Administration advisory panel voted in favor of approval. The development could represent an important step for blood-based screening designed to identify signals associated with multiple cancers from a single blood sample. U.S. Food and Drug Administration
Grail’s FDA Advisory Panel Vote
In September 2026, the FDA’s Molecular and Clinical Genetics Devices Panel reviewed Grail’s premarket approval application for Galleri. The panel voted 7-2, with one abstention, that the benefits of the test outweighed its risks. Members also unanimously supported the test’s safety, while the effectiveness vote was 6-4. GRAIL, Inc.
The NHS-Galleri study, which included more than 140,000 participants, did not show a statistically significant reduction in cancers diagnosed at stages 3 or 4 after three rounds of screening. This has fueled debate about whether detecting cancer signals earlier will translate into better long-term outcomes. STAT
Grail’s Potential Impact on Cancer Screening
If the FDA ultimately approves the test, Grail’s Galleri could gain substantially broader access in the U.S. Approval could also influence insurance coverage and accelerate adoption of multi-cancer early detection technologies. Reuters reported that the potential U.S. market could reach tens of billions of dollars annually if coverage expands. Reuters
For Grail’s technology, the FDA decision will therefore be closely watched by healthcare providers, investors, researchers and patients. Approval would mark an important regulatory achievement, but continued research will be essential to determine whether multi-cancer blood screening can deliver meaningful improvements in cancer outcomes.
How Grail’s Galleri Test Works
Grail’s Galleri test is designed to analyze cell-free DNA from a blood sample and identify cancer-associated methylation patterns. It can also predict the tissue or organ where a detected cancer signal may have originated, helping healthcare professionals determine which diagnostic tests may be appropriate next. U.S. Food and Drug Administration
The test is intended for adults aged 50 and older and is designed to complement—not replace—established cancer screening methods. A positive result requires follow-up diagnostic testing, while a negative result does not rule out cancer. U.S. Food and Drug Administration
Grail’s Test Faces Important Questions
Despite the FDA panel’s recommendation, Grail’s technology continues to face questions about its clinical effectiveness. Critics have pointed to uncertainty over whether multi-cancer detection can ultimately reduce cancer mortality, as well as concerns about false-positive results, false reassurance and unnecessary follow-up procedures.
