Breast
Mammography is the established first screening tool.
Breast cancer blood testGuide plannedEvidence-led cancer screening guide
Galleri screens for a cancer-associated signal shared by more than 50 cancer types. The evidence is not equally strong for every cancer—and being listed is not a promise that a signal will be found.
Read the evidence by groupA named medical reviewer has not yet been supplied. This page is pending physician review and should not be used as medical advice.
The short answer
The Galleri test is designed to detect a signal shared by more than 50 cancer types in one blood draw. Galleri.com currently lists 50 entries that study participants had when a cancer signal was detected. The strongest aggregate evidence is for GRAIL’s pre-specified group of 12: anus, bladder, colorectal, esophagus, head and neck, liver/bile duct, lung, lymphoma, myeloma, ovary, pancreas and stomach.
The list records cancer types seen in study participants when a signal was found. It is not a per-cancer performance claim, and Galleri does not detect a signal for all cancers. Sensitivity reported for a group cannot be applied to each cancer in that group.
Galleri analyzes methylation patterns in cell-free DNA (cfDNA). If it finds a cancer-associated signal, its Cancer Signal Origin result predicts where that signal may have started to help guide diagnostic follow-up. Galleri does not diagnose cancer or predict future cancer risk.
Galleri is a prescription, physician-ordered multi-cancer early detection (MCED) test for adults at elevated risk, such as those age 50 or older. It is used in addition to guideline screening. Explore how Galleri works and who may be eligible.
Group 01
GRAIL’s pre-specified group of 12 is behind its headline performance figures. In PATHFINDER 2 full results, episode sensitivity was 69.8% for this group and 39.3% across all cancers (GRAIL, ASCO, May 31, 2026). That 69.8% is not the sensitivity of each cancer.
GRAIL selected this group because it attributes about two-thirds of US cancer deaths to these cancers. Most have no guideline screening test for average-risk adults; colorectal and lung are the two with established population recommendations.
| Cancer group | Read the cancer guide | Guideline screening for average-risk adults |
|---|---|---|
| Colorectal | Colon cancer blood testGuide planned | Yes — stool-based tests and colonoscopy (USPSTF A/B). |
| Lung | Lung cancer blood test | Yes — annual low-dose CT for adults who meet age and smoking-history criteria (USPSTF B). |
| Lymphoma | Lymphoma blood test | No routine population screening. |
| Myeloma / plasma cell neoplasm | Multiple myeloma blood test | No routine population screening. |
| Ovary | Ovarian cancer blood test | No routine screening for average-risk adults; USPSTF recommends against it. |
| Pancreas | Pancreatic cancer blood test | No routine screening for average-risk adults. |
| Liver / bile duct | Liver cancer screeningGuide planned | Targeted surveillance may apply with cirrhosis or chronic hepatitis B; none for the general population. |
| Esophagus | Esophageal cancer screeningGuide planned | No routine screening for average-risk adults. |
| Bladder | Bladder cancer screeningGuide planned | No routine population screening. |
| Stomach | Stomach cancer screeningGuide planned | No routine population screening in the US. |
| Head and neck | Head and neck cancer screeningGuide plannedThroat cancer screeningGuide planned | No routine screening for average-risk adults. |
| Anus | Covered below | Targeted screening may be considered for some higher-risk groups; no routine population screening. |
Anal cancer is one of GRAIL’s pre-specified 12, but there is no routine anal cancer blood test. People in some higher-risk groups may be offered targeted screening; ask a doctor what applies to you. Galleri does not replace that care.
Group 02
Breast, prostate, leukemia, melanoma of the skin, kidney and testis appear on galleri.com’s list, but they are outside the group of 12. Performance for these cancers is low or not established; Galleri is not the right first screening tool for them.
Mammography is the established first screening tool.
Breast cancer blood testGuide plannedBegin with an informed PSA discussion with your clinician.
Prostate cancer blood testClinical evaluation and a complete blood count are the appropriate starting points when indicated.
Leukemia blood testGuide plannedA clinician skin exam is the appropriate first evaluation.
Skin cancer blood testGuide plannedThere is no routine population blood-screening test.
Kidney cancer blood testGuide plannedNew symptoms or a mass need prompt clinical evaluation.
Testicular cancer screeningGuide plannedThyroid is not on GRAIL’s current list; a concern needs targeted clinical evaluation.
Thyroid cancer blood testGuide plannedThyroid cancer is not on GRAIL’s current list as reviewed October 5, 2026. A complete blood count can support a leukemia evaluation when clinically indicated, but it is not a general cancer screen. Standard clinical testing remains the first step for every cancer in this section.
The remaining entries
The current Galleri list also includes mostly uncommon cancer types. Being listed does not mean that Galleri finds each one reliably.
Bone appears on the list; a dedicated bone cancer blood test guide is planned. Bile ducts and head-and-neck sites including the nasal cavity, nasopharynx, oral cavity, oropharynx, hypopharynx and larynx are represented in the 12-cancer grouping above. The live GRAIL cancer-type list remains the source of record.
A clean result is not an all-clear
Galleri does not detect all cancers. In PATHFINDER 2 it found 39.3% of cancers diagnosed within 12 months (GRAIL, May 31, 2026). A “No Cancer Signal Detected” result does not rule out cancer.
The stage figures were reported by J. Pines, MD (Forbes, February 8, 2026) from a case-control validation study. They are not real-world, per-cancer estimates. Early cancers and cancers that shed little DNA are more likely to be missed. Brain tumors are not on GRAIL’s current list; a dedicated brain cancer blood test guide is planned.
Prospective evidence first
PATHFINDER 2 followed 35,878 adults age 50 or older with no suspicion of cancer. Its full results are the most relevant headline because they reflect prospective screening rather than a case-control sample.
These are PATHFINDER 2 full results presented at ASCO on May 31, 2026. The earlier October 2025 interim figures—73.7% for the 12, 40.4% across all cancers and 61.6% positive predictive value—were preliminary and are superseded for headline use.
The NHS-Galleri trial did not meet its primary endpoint. Earlier case-control validation, including Klein et al. in Annals of Oncology (2021), reported higher sensitivity and should not be read as a real-world screening estimate. See Galleri accuracy by study for the wider evidence context.
Supplement, never substitute
USPSTF has A or B recommendations for breast, cervical, colorectal and lung screening. Prostate screening is an individual shared decision. No major guideline body endorses Galleri as a replacement.
| Cancer | Established screening | How Galleri relates |
|---|---|---|
| Breast | Mammography for eligible adults (USPSTF B). | Galleri may supplement; it does not replace mammography. |
| Cervical | HPV testing and/or cervical cytology by age and risk (USPSTF A/B). | Galleri does not replace Pap or HPV testing. |
| Colorectal | Stool-based tests, colonoscopy and other recommended options (USPSTF A/B). | Galleri does not replace colorectal screening. |
| Lung | Annual low-dose CT for adults who meet eligibility criteria (USPSTF B). | Galleri does not replace low-dose CT. |
| Prostate | Individual PSA-based screening decision for eligible adults (USPSTF C). | Galleri does not replace a PSA discussion. |
| Skin | Risk-based clinical evaluation; no USPSTF population-screening recommendation for asymptomatic adults. | Galleri does not replace a skin exam or evaluation of a changing lesion. |
GRAIL states that guideline-recommended screening finds 14% of US cancers, citing NORC (2022), and that nearly 80% of cancer deaths arise from cancers without recommended screening, citing Ofman et al., Cancer Biomarkers (2025). These figures come from GRAIL and GRAIL-affiliated authors working with the American Cancer Society; they are included with that conflict context, not as an endorsement of Galleri.
Regulatory status · October 5, 2026
No. Galleri is not FDA-approved. An FDA advisory panel voted on September 23, 2026: 7–2 with one abstention that benefits outweigh risks, 10–0 on safety, and 6–4 on effectiveness. The vote is non-binding; FDA has issued no decision. Galleri is currently available as a laboratory-developed test.
Read the Galleri FDA status in fullPrice and access
Through Human Longevity, Galleri costs $798 as a one-time charge. It is HSA/FSA eligible and an HLI physician places the order. GRAIL listed a $949 list price and $799 self-pay price as of October 5, 2026. Medicare does not cover Galleri; follow-up diagnostic testing is separate.
Galleri cost, insurance and the Medicare pathwayClear answers
Thyroid cancer is not on galleri.com’s current list of cancer types as reviewed on October 5, 2026. A thyroid concern should be evaluated with targeted clinical care; Galleri is not a substitute for it.
Thyroid cancer guide plannedGalleri does not find every cancer and a “No Cancer Signal Detected” result cannot rule cancer out. Brain tumors and thyroid cancer are not on GRAIL’s current list, and even cancers on the list may be missed.
See what Galleri missesThat depends on age, risk, what routine screening you have completed, and how you would approach follow-up. It is an added screen rather than a replacement for established screening.
Review the Galleri test and its limitationsGRAIL describes Galleri as a repeat screening test, generally once a year. Your physician should determine whether and when repeat testing fits your care.
Medicare does not currently cover Galleri, and most health plans do not routinely cover it. Check your plan and remember that follow-up diagnostic testing is separate.
See cost and coverage detailsTwo different questions
A reader scanning this list is usually asking about one cancer. For breast, prostate, leukemia, melanoma and other cancers outside GRAIL’s 12, the established clinical test is the better first step. For every cancer, a “No Cancer Signal Detected” result cannot rule it out.
Colonoscopy, mammography, low-dose CT for eligible smokers, Pap/HPV testing, PSA discussion and skin examination answer current screening questions with established pathways.
Galleri screens a blood sample for a cancer-associated methylation signal. Human Longevity resells GRAIL’s test for $798; it is the same Galleri test offered through other channels.
A genome may identify inherited variants that affect lifetime risk. It does not detect a cancer that already exists, and a normal result does not mean low cancer risk.
For relevant family histories, read about BRCA1 and BRCA2 in a genome and Lynch syndrome. A genetic finding may need confirmatory clinical testing and genetic counseling. See what the $599 genome service includes. Galleri and whole genome sequencing answer different questions; neither replaces the other or guideline screening.
Key sources include Galleri’s cancer-type list (reviewed October 5, 2026); GRAIL’s NHS-Galleri release (February 19, 2026); PATHFINDER 2 full results presented at ASCO (May 31, 2026); Klein et al., Annals of Oncology (2021, case-control); J. Pines, MD, Forbes (February 8, 2026); USPSTF screening recommendations; NORC (2022); Ofman et al., Cancer Biomarkers (2025); and FDA advisory committee materials and GRAIL’s release (September 23, 2026).