Galleri Detection.
Multi-Cancer Early Detection · Single Blood Draw · 50+ Cancer Types
GRAIL’s Galleri is a blood-based multi-cancer early detection test that screens for signal from 50+ cancer types — including many cancers without a standard screening protocol. One blood draw at TrufaMED’s Surfside clinic, results in 2 weeks, reviewed with a board-certified physician.
What is Galleri multi-cancer early detection?
What This Screening Detects.
Galleri analyzes methylation patterns in cell-free DNA to detect a shared cancer signal across 50+ cancer types. When a signal is detected, the test also predicts a Cancer Signal Origin to direct follow-up workup.
GRAIL Galleri · by the numbers.
Galleri is supported by one of the largest evidence bases in cancer screening: the Circulating Cell-Free Genome Atlas (CCGA) studies, the PATHFINDER prospective cohort, the PATHFINDER 2 registrational study (35,878 participants), and the NHS-Galleri trial in the United Kingdom (140,000+ participants). Numbers below come directly from those published studies.
The cancers with no other screening test.
Mammography, colonoscopy, low-dose CT, Pap, and PSA are all important — and Galleri does not replace any of them. Galleri’s value is the cancers it catches that current population screening misses entirely. Approximately 70% of U.S. cancer deaths are from cancers without recommended screening.
Pancreatic Cancer
5-year survival is roughly 12% because most cases are diagnosed at stage III or IV. Stage-shifted detection via Galleri can meaningfully change that trajectory.
Ovarian Cancer
No effective population screening exists. Galleri provides a blood-based signal years before the typical late-stage symptomatic presentation.
Esophageal Cancer
Rising incidence and aggressive biology make early detection critical — endoscopy is invasive and not a population-level screen.
Liver / Bile Duct Cancer
Liver cancer survival drops precipitously between stage I and stage III — early detection genuinely saves lives.
Gastric Cancer
Often silent until advanced; no recommended screening for average-risk adults in the United States.
Head & Neck Cancers
Oropharyngeal and laryngeal cancers are routinely diagnosed in symptomatic stages without dedicated screening pathways.
If we detect a cancer signal.
A “Cancer Signal Detected” result is not a diagnosis — it is a focused starting point. Because Galleri also predicts the tissue of origin, the diagnostic workup is targeted rather than a body-wide search.
Step 1: Physician Review
Your TrufaMED physician reviews the report with you in person or via telehealth, explains the predicted Cancer Signal Origin, and outlines the workup pathway specific to that organ system.
Step 2: Targeted Imaging
Imaging is selected based on the CSO prediction — CT, MRI, or PET as appropriate — rather than a broad diagnostic odyssey. We coordinate referrals to imaging centers and specialists as needed.
Step 3: Specialist Referral
If imaging confirms a finding, you are referred to the appropriate oncology subspecialist (GI, gynecologic, hepatobiliary, etc.) for biopsy and definitive diagnosis.
Step 4: Continued Standard Screening
Whether or not a signal is detected, continue all USPSTF-recommended screenings on schedule. Galleri adds to standard of care — it does not replace it.
Eligibility: Galleri is intended for adults aged 50 and older, or adults with elevated cancer risk — including a strong family history or known genetic predisposition. It is FDA-investigational, not FDA-approved, and currently self-pay. Retail price: $1,150, set by GRAIL. HSA and FSA eligible when ordered by a physician.
How It Works.
From consult to action plan, every step is physician-led.
Who Should Consider.
Galleri is most appropriate for the following groups:
Why TrufaMED for Galleri Multi-Cancer Early Detection.
Why patients choose TrufaMED for Galleri:
50+ cancer types from a single blood draw.
Pricing & Coverage.
Self-pay only: Galleri is not currently covered by commercial or Medicare insurance. Retail price: $1,150, set by GRAIL.
HSA/FSA eligible: Galleri qualifies for HSA and FSA reimbursement when ordered by a physician, which TrufaMED does as a standard part of the workflow.
What is included: Physician consult, test order, blood draw, GRAIL lab analysis, and results review visit. Follow-up imaging or specialist referrals if Cancer Signal Detected are billed separately.
Physician-Led.
Every order, interpretation, and follow-up is delivered by a board-certified MD.
Visit Us in Surfside, FL.
Surfside, FL 33154
Frequently Asked Questions.
What does ‘Cancer Signal Detected’ mean?
It means Galleri identified DNA methylation patterns consistent with cancer in your blood sample, and predicts a Cancer Signal Origin (the most likely tissue of origin). This is not a diagnosis — it is a strong indication that targeted diagnostic workup is needed. Your TrufaMED physician coordinates that workup.
Is Galleri FDA-approved?
No. Galleri is offered as a Laboratory Developed Test (LDT) by GRAIL under CLIA certification. It is not currently FDA-approved or cleared. Performance data comes from GRAIL’s PATHFINDER and STRIVE studies.
What is the false-positive rate?
In GRAIL’s published data, the false-positive rate is roughly 0.5%, meaning about 1 in 200 healthy individuals will receive a Cancer Signal Detected result that does not correspond to cancer on workup. We discuss this clearly before testing.
Does insurance cover Galleri?
Not currently. Galleri is self-pay only at $1,150. It is HSA and FSA eligible when ordered by a physician.
Can Galleri replace my mammogram or colonoscopy?
No. Galleri is complementary to standard cancer screening, not a replacement. Mammography, colonoscopy, cervical screening, and PSA where indicated remain the standard of care. Galleri adds detection capability for many cancers without a routine screening test.
How often should I retest?
GRAIL’s recommended cadence is annual testing for adults 50+ at elevated risk. Your TrufaMED physician will personalize the cadence based on your overall risk profile.
What if I have already had cancer?
Galleri can be used as additional surveillance for second primary cancers in survivors, but it must be coordinated with your treating oncologist. We do not use it to monitor known active disease.
Is there a Florida-specific approval?
Florida does not require state-level approval for LDTs offered under CLIA. Galleri is available in Florida through CLIA-certified physician offices, including TrufaMED.
What if Galleri detects a signal but follow-up is negative?
This is possible — the false-positive rate is approximately 0.5%. If follow-up imaging and workup find no cancer, we typically recommend repeating Galleri in 12 months and continuing standard-of-care screening on schedule.
How long does the blood draw take?
Approximately 10 minutes total for the visit. Two tubes of blood are drawn into special preservatives provided by GRAIL.
Can I take Galleri before age 50?
Yes, with physician evaluation. Patients with strong family history of cancer, known cancer-predisposition mutations, prior cancer history, or heavy environmental risk factors are reasonable candidates under 50. Your TrufaMED physician determines clinical appropriateness.
How is my data protected?
GRAIL is HIPAA-compliant and does not share identifiable data with third parties without consent. Federal GINA law prevents health insurance and employment discrimination based on genetic test results, though GINA does not extend to life, disability, or long-term care insurance.
Other TrufaMED Services.
Ready to get started?
Speak with a TrufaMED physician about whether galleri multi-cancer early detection is appropriate for you.
