Multi-Cancer Early Detection Test FAQs

The test, called Galleri®, is offered by a company called GRAIL. It received Food and Drug Administration Breakthrough Device designation in October 2021, fast-tracking its review for full FDA approval while additional data is gathered in large-scale clinical trials.

The Multi-Cancer Early Detection test detects more than 50 types of cancer signals, many of which are not commonly screened for today, through a simple blood sample. The MCED test doesn’t diagnose cancer and not all cancers may be detected in the blood.

The MCED test looks for signals present in the blood that may be associated with cancer at the time you give your blood sample. If a cancer signal is detected, the results can point to where in the body the cancer is coming from to help your health care provider guide the next steps.

The MCED test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. Complete our online screener to see if you’re eligible. The MCED test is intended to be used in addition to, and not replace, other cancer screening tests recommended by your health care provider.

Family history is only one of many risk factors associated with cancer development. Other risk factors include eating habits, lifestyle, living or working environments, genetics and many other factors. So you may still be a good candidate for the MCED test without a family history.

In a large-scale, clinical validation sub-study of Circulating Cell-free Genome Atlas, the MCED test detected more than 50 cancer types across all stages, including:

Adrenal Cortical Carcinoma
Ampulla of Vater
Anus
Appendix, Carcinoma

Bile Ducts, Distal
Bile Ducts, Intrahepatic
Bile Ducts, 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

Oral Cavity
Oropharynx (HPV-Mediated, p16+)
Oropharynx (p16-) and Hypopharynx
Ovary, Fallopian Tube and Primary Peritoneum

Pancreas, exocrine
Penis
Plasma Cell Myeloma and Plasma Cell Disorders
Prostate

Small Intestine
Soft Tissue Sarcoma of the Abdomen and Thoracic Visceral Organs
Soft Tissue Sarcoma of the Head and Neck
Soft Tissue Sarcoma of the Retroperitoneum
Soft Tissue Sarcoma of the Trunk and Extremities
Soft Tissue Sarcoma Unusual Histologies and Sites
Stomach

Testis

Ureter, Renal Pelvis
Uterus, Carcinoma and Carcinosarcoma
Uterus, Sarcoma

Vagina
Vulva

Based on data from GRAIL’s studies, the MCED test has shown a low false-positive rate of 0.5% (detecting a cancer signal when no cancer is present). This means that in approximately 200 people tested, only one person would be expected to receive a false-positive result.

GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing.

You can complete our online screener to see if you’re eligible for the test. If you’re eligible, the Mercy care team will reach out with next steps.

The MCED test will be available in 11 Mercy labs located within our hospitals. The Mercy care team will work with you to schedule your appointment at the facility closest to you.

• Arkansas: Mercy Hospital Fort Smith, Mercy Hospital Rogers
  
• Eastern Missouri: Mercy Hospital St. Louis, Mercy Hospital Washington, Mercy Hospital South
• Southern Missouri: Mercy Hospital Lebanon, Mercy Hospital Springfield, Mercy Hospital Joplin
  
• Oklahoma: Mercy Hospital Oklahoma City, Mercy Hospital Ardmore, Mercy Hospital Ada

Screening frequency is an area of considerable research right now, with guidelines evolving. While we expect to learn more over the next few years based on current studies, our general recommendation is to consider a repeat test every three years. If you’re interested in more frequent retesting based on your unique risks or circumstances, our central MCED team will review that on a case-by-case basis.

People 22 and older, but it will be especially recommended for adults with an elevated risk for cancer, such as those age 50 or above with select pre-existing conditions and/or family history. 

If you request the test yourself using an online form, the Mercy care team will walk you through the process. A Mercy physician or provider can also refer you to the right Mercy care team.

Our secure mercy.net website is built to protect your private information while giving you the most personal experience as a Mercy patient. Your SSN can help us give you the information that’s most important to you, and if you’re not already in our electronic health records, it will help us create a new patient account for you.

Absolutely. Not knowing one’s familial risk factors can be disconcerting and troubling for patients; MCED testing can provide peace of mind. In fact, since initiating the program at Mercy, we’ve recommended testing to multiple people in your same situation. Of course, we also recommend ongoing preventive health care and other applicable cancer screening tests be done for the same reason.

Mercy’s price for the MCED test is $949.

Payment options are available.

If you’re at an elevated risk for cancer due to environmental or genetic factors and are unable to pay the total cost of the test, Mercy will work with you individually to assist in making this service accessible.

Payment options are available.

Currently, this test is not covered by insurance. The test is new to the market and represents a significant innovation in cancer screening.

Payment options are available.

Patients have the opportunity to purchase the test with a down payment of $149 and $100 a month for eight months. The expense may qualify for HSA and flex spending accounts, as well. Check with your FSA/HSA account administrator or insurance company to determine eligibility.

You may be able to use pre-tax dollars in your flexible spending account (FSA) or health savings account (HSA) to pay for the MCED test. Check with your FSA/HSA account administrator or insurance company to determine eligibility.

Payment options are available.

Because each insurance company creates its own criteria for coverage of tests, your Mercy care team will work with you and your insurance company to obtain coverage of further diagnostic testing.

Payment options are available.

Insurance companies must cover necessary preventive services. However, it’s the insurance company or federal/state regulations that designate what is and is not a necessary preventive service. Only a handful of insurance companies at this time are designating this test as a covered preventive service, and there are no regulatory requirements that address the MCED test. The Centers for Medicare and Medicaid Services typically align with the U.S. Preventive Services Task Force (USPSTF) recommendations when it comes to deeming coverage related to preventive care for Medicare beneficiaries. The USPSTF has not made any recommendations yet on MCED testing.

No preparation or fasting is required for the Multi-Cancer Early Detection test.

Approximately 1.5 tablespoons (or about 20 ml) of blood in two tubes, typically from a vein in your arm.

MCED testing is a newly developed molecular test that’s viewed as complementary to many of our other testing and screening methodologies. We’ve had cases at Mercy where MCED testing has revealed important information about the source of symptoms being investigated that led to a definitive diagnosis. It’s not designed to be a test for following progression of a known cancer or looking for recurrence, and we would not perform the test if you’ve recently been diagnosed with cancer.

This test is not recommended for patients with a current diagnosis of cancer. Because of the way the test works, it wouldn’t be able to differentiate signals from breast cancer in the breast versus breast cancer in other parts of the body.

• You can request a Multi-Cancer Early Detection test online. Also, your provider, who knows your history, can place a referral to the Mercy care team.
• The Mercy care team will screen your health history and, if appropriate, schedule your test to be performed at the closest Mercy Lab Services location.
• The lab technician who takes your sample will pack and ship your blood back to GRAIL for processing.
• Your sample will arrive at GRAIL one to two business days after your lab visit.
• The Mercy Care team will share the test results with you and your primary care provider about two weeks after your lab visit. They’ll also work with your primary care provider to obtain any additional diagnostic tests and coordinate any recommended referrals.

It takes about two weeks after your lab visit to receive your test results from your Mercy care team who ordered your test.

This means that there is a suspicion of cancer but not a diagnosis of cancer. The Multi-Cancer Early Detection test can point to where in the body the cancer is coming from to help your Mercy care team guide next steps. Your Mercy care team will discuss appropriate follow-up testing to confirm if cancer is present.

This means that no cancer signal was found. However, not all cancers can be detected by the Multi-Cancer Early Detection test. Continue with all routine screening tests recommended by your care team. Missing routine screenings or ignoring symptoms can lead to a delayed diagnosis of cancer.

The MCED test looks for a common cancer signal across more than 50 types of cancer, and not all cancers may be detected in the blood. Recommended routine cancer screenings such as colonoscopy or mammograms are commonly used and have been shown to reduce cancer deaths. The MCED test is intended to be used in addition to, and not replace, these tests and can help maximize the benefits of early cancer detection. Missing recommended screenings or ignoring symptoms could lead to a delayed diagnosis of cancer. Ask your health care provider about what cancer screening tests are right for you.

The MCED test is a screening test that detects cancer signals in blood. When a signal is detected, the test also indicates where in the body the signal is coming from with high accuracy.

The MCED test isn’t a diagnostic test. Additional tests ordered by your Mercy care team are needed to confirm if cancer is present. These tests may include blood work or imaging.

The MCED test is looking for the presence of cancer at the time your blood sample is taken, but you may develop cancer in the future. The test doesn’t measure your risk of developing cancer in the future, and it does not detect all cancers.

If you receive a “cancer signal detected” result with the Multi-Cancer Early Detection test, but a follow-up diagnostic evaluation doesn’t confirm cancer, your Mercy care team will review the different recommendations with you.

The prevalence of cancer in the patient population we’re testing is approximately 1.19%, or six out of 500 people. That means that if we tested 500 people, six of them are likely to have cancer, and we would likely find three of the six cancers with the MCED test. (Regarding the other three, it’s important to keep in mind that many of the cancers we find currently have no other way to screen for them.) In our population of 494 patients above without cancer, if we tested all of them, we would expect that approximately 492 would have a negative result and approximately 2.5 would have a false positive test requiring further investigation.