Advanced Cancer Screening at Salerno Wellness

How the Galleri® Test Works

The Galleri® test is a multi-cancer early detection (MCED) blood test that screens for a shared cancer signal across more than 50 types of cancer, including many that lack recommended screening options.

1. Blood Sample Collection

A simple blood draw is performed at Salerno Wellness.

2. cfDNA Extraction

The lab analyzes cell-free DNA (cfDNA)—tiny fragments of DNA released into the bloodstream, which may originate from both healthy and cancerous cells.

3. Methylation Pattern Analysis

Using next-generation sequencing and machine learning, the test detects abnormal methylation patterns—chemical modifications to the DNA that are often associated with cancer. These patterns differ between healthy and cancerous cells and help identify the specific type of cancer.

4. Cancer Signal Detection

If a cancer signal is detected, the Galleri test can predict the tissue or organ of origin, helping guide further diagnostic evaluation.

Key Points

• It is a screening tool, not a diagnostic test.
• Designed to be used in addition to, not instead of, routine cancer screenings.
• Most helpful for detecting cancers that do not have standard screening options, such as pancreatic, liver, or ovarian cancer.

Types of Cancer the Test Identifies

The Galleri® test is a multi-cancer early detection blood test that looks for signals associated with over 50 types of cancer. It does this by analyzing cell-free DNA in your blood for abnormal methylation patterns linked to cancer.

This test is especially valuable because many of the cancers it can detect do not have routine screening tests and are often diagnosed at late stages.

• Adrenal Cortical Carcinoma
• Ampulla of Vater
• Anus
• Appendix (Carcinoma)
• Bile Ducts (Distal, Intrahepatic, Perihilar)
• Bladder (Urinary)
• Bone
• Breast
• Cervix
• Colon and Rectum
• Esophagus and Esophagogastric Junction
• Gallbladder
• Gastrointestinal Stromal Tumor
• Gestational Trophoblastic Neoplasms
• Kidney
• Larynx
• Leukemia
• Liver
• Lung
• Lymphoma (Hodgkin and Non-Hodgkin)
• Melanoma of the Skin
• Merkel Cell Carcinoma
• Mesothelioma (Malignant Pleural)
• Nasal Cavity and Paranasal Sinuses
• Nasopharynx
• Neuroendocrine Tumors of the Appendix
• Neuroendocrine Tumors of the Colon and Rectum
• Neuroendocrine Tumors of the Pancreas
• Oropharynx
• Ovary
• Pancreas (Exocrine)
• Penis
• Peritoneum
• Pleura
• Prostate
• Salivary Gland
• Small Intestine
• Soft Tissue Sarcoma
• Stomach
• Testis
• Thymus
• Thyroid
• Tonsil
• Ureter
• Uterus (Corpus and Endometrium)
• Uterus, Sarcoma
• Vagina
• Vulva

Benefits of the Galleri® Test

• Detects Multiple Cancers at Once: Screens for a shared cancer signal across more than 50 types of cancer with a single blood draw.
• Catches Cancers Without Routine Screening: Identifies hard-to-detect cancers like pancreatic, ovarian, and liver that lack recommended screening tests.
• Minimally Invasive: Requires only a simple blood test, with no imaging or sedation.
• High Specificity: Offers a low false-positive rate, reducing the chance of unnecessary follow-up testing.
• Tissue of Origin Prediction: Provides insight into the likely organ or tissue where the cancer signal originated.
• Promotes Early Detection: Helps find cancers before symptoms arise, potentially improving treatment outcomes.
• Convenient & Quick: Blood draw takes just minutes; results are typically available within 10 business days.
• Complements Existing Screenings: Designed to be used in addition to routine cancer screenings—not as a substitute.

Who Is the Galleri® Test For?

The Galleri® multi-cancer early detection test is intended for individuals at increased risk of developing cancer. It is designed to be used alongside routine screenings—not as a replacement—and is most effective as a proactive health measure.

Ideal Candidates

• Adults aged 50 and older: The risk of developing cancer rises with age, making this group the primary population for the test.
• Individuals with risk factors: This includes those with a family history of cancer, known genetic predispositions (e.g., BRCA mutations), or lifestyle-related risks such as smoking or chronic inflammation.
• People seeking additional screening: Especially useful for detecting cancers that do not have established screening tests.
• Asymptomatic individuals: Best suited for those who are not currently experiencing any symptoms of cancer.

Not Recommended For

• People with a known or suspected cancer diagnosis
• Individuals currently experiencing cancer-related symptoms
• Adults under 50 without significant risk factors (unless advised by a healthcare provider)

Note: Always consult with a healthcare provider to determine whether the Galleri® test is appropriate for your specific health needs and cancer risk profile.

Galleri® Test Procedure Overview

1. Eligibility & Consultation:
   Patients aged 50 and older—or those with elevated cancer risk—should consult with a healthcare provider to determine if the test is appropriate.
2. Blood Sample Collection:
   A standard blood draw is performed at one of our offices.
3. Laboratory Analysis:
   The sample is sent to GRAIL’s lab, where it is analyzed for abnormal methylation patterns in cell-free DNA (cfDNA) that may indicate cancer.
4. Results:
   Results are typically available within 10 business days and will indicate either “Cancer Signal Detected” or “No Cancer Signal Detected,” along with the predicted tissue or organ of origin if applicable.
5. Follow-Up:
   A positive result requires further diagnostic testing (e.g., imaging, biopsy). Patients should review results with their healthcare provider to determine appropriate next steps.

Note: The Galleri® test is not a diagnostic test. It is a screening tool designed to identify potential cancer signals and guide further evaluation.

Success Rate and Evidence of the Galleri® Test

The Galleri® test, developed by GRAIL, Inc., is a multi-cancer early detection (MCED) blood test supported by several large-scale clinical studies. It is designed to complement—not replace—routine cancer screenings by detecting over 50 types of cancer through a single blood draw.

Strengths

• Detects rare and hard-to-screen cancers
• Very low false-positive rate (high specificity)
• Identifies likely cancer signal origin to guide follow-up

Limitations

• Lower sensitivity for early-stage cancers compared to traditional single-cancer tests
• Not FDA-approved for standalone cancer diagnosis
• Currently recommended as a complementary screening tool

The Galleri® test is a promising innovation for early cancer detection, especially for cancers lacking established screening protocols. Ongoing research aims to improve early-stage sensitivity and expand clinical adoption.

Clinical Studies Behind the Galleri® Test

The Galleri test is supported by several large-scale studies aimed at evaluating how well it detects cancer early using a simple blood draw. Here’s what the results show:

1. PATHFINDER Study (2022)

• Participants: Over 6,600 people aged 50+ with no known cancer symptoms
• Positive Predictive Value (PPV): 38%
  ➤ When the Galleri test detects a cancer signal, there's a 38% chance the person actually has cancer.
• Specificity: Over 99%
  ➤ Very low false-positive rate—if the test says you don’t have cancer, it’s highly likely to be correct.
• Median Time to Diagnosis: 79 days
  ➤ Average time from blood draw to diagnosis confirmation in positive cases.

2. CCGA Study (Circulating Cell-Free Genome Atlas)

• Participants: Over 15,000 individuals
• Overall Sensitivity: ~51.5%
  ➤ The test detected cancer in about half of the total cancer cases, across all stages and types.
• Stage IV Sensitivity: Over 90%
• Stage I Sensitivity: ~10–30%, depending on cancer type
• Cancer Signal Origin Accuracy: 88%
  ➤ In true positive cases, the test correctly identified the cancer’s likely origin 88% of the time.

Detection Sensitivity by Cancer Stage

• The Galleri test performs best for detecting later-stage cancers but can still provide early detection for multiple types, especially those without routine screening.
• It has very high specificity, meaning it’s unlikely to give false-positive results.
• The test can accurately identify the likely origin of the cancer signal in most true positive cases.

Risks and Side Effects of the Galleri® Test

The Galleri® multi-cancer early detection (MCED) test is a simple blood test that carries minimal physical risk. However, like any screening tool, it has potential emotional and clinical risks related to result interpretation.

Physical Side Effects

• Minor pain or soreness at the blood draw site
• Bruising
• Lightheadedness or fainting (rare)
• Very low risk of infection at the puncture site

Emotional and Clinical Risks

• False Positives: May indicate a cancer signal when no cancer is present, leading to emotional distress and unnecessary follow-up tests.
• False Negatives: May miss an existing cancer, especially in early stages, potentially delaying diagnosis and treatment.
• Uncertain Results: A positive result does not confirm cancer; it suggests a cancer signal and possible tissue of origin, requiring further diagnostic testing.
• Psychological Impact: Anxiety or stress while awaiting results or responding to ambiguous findings.

Test Limitations

• Not a replacement for traditional screenings such as mammograms or colonoscopies
• Not FDA-approved for standalone cancer diagnosis
• Does not detect all cancers, particularly in early stages

Summary

The Galleri® test is generally safe and offers valuable insight into early cancer detection. However, users should understand the emotional and clinical implications and always consult with a healthcare provider to interpret results and determine appropriate next steps.

Cost and Insurance Information

At Salerno Wellness, the standard fee for the Galleri® multi-cancer early detection test is $2,000. This fee includes a follow-up consultation with one of our providers to review your results and recommend any necessary next steps.

Insurance Coverage

• The Galleri® test is not currently covered by most insurance providers, including Medicare and Medicaid.
• Patients are responsible for the full out-of-pocket cost.
• Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) may be used to pay for the test.

If you have questions about pricing or payment options, please contact us:

• New York Office: (212) 582-1700
• Connecticut Offices: (475) 269-2138
• Email: info@salernocenter.com

Why Choose Salerno Wellness?

Salerno Wellness offers a personalized, integrative approach to early cancer detection. By combining advanced technology with holistic care, we provide a unique and comprehensive experience for patients seeking proactive health solutions.

What Sets Us Apart

• Personalized Follow-Up: Each Galleri® test includes a detailed consultation to review your results and determine next steps tailored to your health needs.
• Holistic, Integrative Care: We blend advanced diagnostics with functional and preventive medicine to support long-term wellness.
• Experienced Medical Team: Led by Dr. John Salerno, our clinicians offer decades of expertise in both traditional and alternative care models.
• Patient-Centered Philosophy: We take time to understand your unique history and lifestyle to deliver truly customized care.
• Convenient Locations: Our offices in New York and Connecticut offer easy access and flexible scheduling.
• Commitment to Prevention: We focus on early detection and proactive care to help you stay ahead of potential health risks.

Frequently Asked Questions (FAQ)

Q. What is the Galleri® test?
A. The Galleri® test is a multi-cancer early detection blood test that screens for over 50 types of cancer by analyzing cell-free DNA (cfDNA) for abnormal methylation patterns.

Q. Who should take the Galleri® test?
A. The test is recommended for adults aged 50 and older, or younger individuals with elevated risk factors such as a family history of cancer or genetic predispositions.

Q. Is the test painful?
A. No, the test only requires a standard blood draw, which is minimally invasive and generally well tolerated.

Q. Does the test replace traditional cancer screenings?
A. No. The Galleri® test is intended to be used in addition to, not as a substitute for, standard cancer screenings like mammograms, colonoscopies, or Pap smears.

Q. How much does the test cost?
A. At Salerno Wellness, the test costs $2,000, which includes a comprehensive follow-up consultation to review your results.

Q. Is the test covered by insurance?
A. At this time, the Galleri® test is not covered by most insurance plans. However, HSA or FSA funds may be used to help cover the cost.

Q. How long does it take to get results?
A. Results are typically available within 10 business days from the time your blood sample is collected.

Q. What happens if my results show a cancer signal?
A. A cancer signal does not mean you have cancer. It means there are patterns consistent with cancer, and further diagnostic testing will be needed. Our team will help guide your next steps.

Q. What if no cancer signal is detected?
A. A “No Cancer Signal Detected” result means that the test did not find evidence of cancer at the time. However, it’s still important to continue with routine screenings and stay in communication with your