Understanding the Galleri Test: A New Approach to Early Cancer Detection

Bottom Line: If you’re proactive about your health, the Galleri test may offer a new way to detect cancer early, before symptoms appear. With just one blood draw, it screens for signals from over 50 types of cancer, many of which currently lack standard screening options. For individuals at elevated risk, it can provide valuable insights and support more informed decisions about your next steps.

Talk to your healthcare provider to determine if the Galleri test aligns with your personal health goals and risk factors.

In This Article:

• What the Galleri test is and how it works

• Which cancers it can detect

• Accuracy, sensitivity, and limitations

• Who should consider getting it

• What to do with positive or negative results

• Cost and insurance details

• What the research says

  
  

What Is the Galleri Test?

The Galleri test is a multi-cancer early detection (MCED) blood test designed to identify signals from over 50 types of cancer in asymptomatic adults aged 50 or older.

It works by detecting tiny fragments of DNA shed by cancer cells into the bloodstream. The test analyzes these patterns to identify the type and potential origin of cancer.

How the Test Works

A small blood sample is collected from your arm during a quick office visit. The sample is then analyzed using advanced artificial intelligence to evaluate cell-free DNA for cancer-associated patterns.

• Results timeline: Typically available within 2 weeks

• Outcome: Either "Cancer Signal Detected" or "No Cancer Signal Detected"

  
  

What Types of Cancer Can It Detect?

The Galleri test screens for a shared signal found in over 50 cancers, many of which currently have no recommended screening guidelines.

Why This Matters

More than 70% of cancer deaths are caused by cancers that aren't part of routine screening programs (like pancreatic, ovarian, and liver cancer).

High-Impact Cancers Detected by Galleri:

• Pancreatic Cancer: 83.7% sensitivity (increases by stage)

• Stomach Cancer: 66.7% sensitivity overall; 100% at stage IV

• Ovarian, Liver, Kidney Cancers: Often show no symptoms early

• Blood Cancers (Leukemia, Lymphoma): Hard to detect through imaging

  
  

How Accurate Is the Galleri Test?

The test demonstrates:

• Specificity: 99.5% (very low false-positive rate)

• Overall sensitivity: 51.5% across all cancers/stages

• High sensitivity (76.3%) for the 12 deadliest cancers

• Cancer origin accuracy: 88.7% when cancer is present

  
  

Positive Result: What Happens Next?

A positive Galleri test does not mean you have cancer, but it indicates a cancer signal was detected.

The follow-up process may include:

• Imaging (CT, MRI, ultrasound) of the predicted area

• Additional blood tests or biomarkers

• Possible biopsy to confirm diagnosis

  
  

On average, the median time to diagnostic resolution is 79 days.

Negative Result: What It Means

A "No Cancer Signal Detected" result means no evidence of cancer was found in the blood. However, it does not guarantee you are cancer-free.

Important: The Galleri test is not a replacement for standard screening tests. It should be used in addition to mammograms, colonoscopies, Pap smears, PSA tests, and other population-based screenings.

Who Should Consider the Galleri Test?

The Galleri test is intended for adults age 50 or older, or younger adults with elevated cancer risk.

Ideal candidates include:

• Individuals over 50

• Those with a strong family history of cancer

• Cancer survivors

• People with BRCA or other high-risk mutations

• Occupational or lifestyle cancer risk exposure

  
  

Not recommended for:

• Anyone under 21

• Pregnant individuals

• Patients undergoing active cancer treatment

  
  

What the Research Says

Clinical Trials & Data

• PATHFINDER Study: 6,621 participants screened; 1.4% diagnosed with cancer

• NHS-Galleri Trial (UK): 140,000+ participants; early data showed promise but more results are needed

• NCI Pilot Study: Starting in 2024 with 24,000 healthy individuals

  
  

Medical Perspective

• American Cancer Society: More research needed before broad use

• AAFP: Test may complement traditional screenings, but requires further validation

  
  

Regulatory Status:

• Not FDA-approved

• Offered under CLIA waiver

• Designated as a "Breakthrough Device" by the FDA in 2019

  
  

Performance Limitations to Consider

• Low sensitivity for early-stage cancers

• Only 11% detection rate for prostate cancer

• False positives/negatives can occur

  
  

Get the Galleri Test at Medical Specialists MN

Located in Edina, MN, we offer:

• On-site lab for immediate blood draw

• No referral or existing patient status required

• Expert interpretation of your results

• Full consultation and follow-up guidance

  
  

Call us today at (952) 225-5400 to schedule your appointment.

Final Thoughts on Cancer Screening: Should You Get the Galleri Test?

The Galleri test is a promising advancement in early cancer detection for individuals at elevated risk. It should be viewed as a supplement to—not a substitute for—standard cancer screenings.

Consider it if:

• You're over 50 or have significant cancer risk factors

• You're seeking additional peace of mind

• You're informed about the test's limitations and cost

  
  

Make your decision with a trusted provider. We’re here to guide you every step of the way.

Medical Disclaimer: This article is for educational purposes only. It does not constitute medical advice. The Galleri test is not FDA-approved and should not replace recommended cancer screenings.