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Confidence is knowing your residual disease status

What is MRD?

Measurable (or minimal) residual disease (MRD) refers to the small number of cancer cells that can remain in the body during and after treatment and may be a sign that cancer is returning.[1] Often these remaining cells are present at such low levels that they do not cause any physical signs or symptoms. With advancements in cancer research and technology, highly-sensitive MRD tests are now available that may help your doctor more accurately identify and track these cells over time.[2]


Why does MRD matter?

ASSESSING YOUR RESPONSE TO THERAPY

With MRD testing, you and your doctor have a personalized way to track—and talk about—your body’s individual response to treatment. In some cases, MRD testing along with other clinical information may even help your doctor to more accurately predict the long-term results of your treatment.[1]

Knowing how much cancer may still be present in your body may allow your physician to tailor your treatment plan to better help fight your disease.

DETECTING RETURNING DISEASE

In remission, even if you aren’t experiencing any symptoms, you may still feel anxious or worried that the cancer will return. Tracking MRD can help detect the return of cancer before physical signs and symptoms arise.[3,4]

Early detection of returning disease may allow you and your physician to respond quickly to fight your disease.

TRACKING YOUR DISEASE OVER TIME

While remission is a relief for many patients, it may be accompanied by a feeling of uncertainty as to whether remission will last. During remission, your physician can use MRD testing to see if any cancer cells are returning.[2]

Regular MRD assessment can help you and your care team feel confident in understanding your cancer and how your disease burden is changing over time.


What is clonoSEQ?

The clonoSEQ® (pronounced clo-no-seek) Assay is the first and only FDA-cleared test that detects, counts, and tracks MRD in bone marrow samples from patients with B-cell acute lymphoblastic leukemia (B-ALL) or multiple myeloma, and blood or bone marrow samples from patients with chronic lymphocytic leukemia (CLL).[2]

Much like your local grocery store uses barcodes to identify products in the check-out line, clonoSEQ uses unique DNA sequences associated with cancer as barcodes to identify the cancer cells in your body. At diagnosis, clonoSEQ looks for, identifies, and counts your cancer’s unique barcodes.[2]

In follow-up tests during treatment and remission, clonoSEQ looks for these specific barcodes in a bone marrow sample provided by your physician and counts them to determine how the number of these barcodes may have changed since your last MRD test. This information will help you and your doctor understand how the amount of disease in your body may be changing over time.[2]

Because clonoSEQ can detect one single cancer cell among a million healthy cells (provided sufficient sample material), you and your doctor can be confident you know how much residual disease is present after each clonoSEQ test.[2] Together, you and your healthcare team can keep a watchful eye on MRD trends and use them to inform important treatment decisions.

References to “cancer” or “disease” on this webpage refer specifically to myeloma, B-ALL, and CLL. References to “sample” refer to bone marrow or blood. Talk to your doctor about your options if you have another type of blood cancer and are interested in MRD testing.

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How does clonoSEQ work?

clonoSEQ testing identifies, counts, and tracks residual disease that may remain in your body during and after treatment. It works by identifying the specific DNA sequence barcodes associated with your disease and then tracks these sequences over time. Even if cancer goes into remission, clonoSEQ can continue to search for these barcodes with periodic MRD testing to help detect returning disease.[2]

STEP 1: CLONALITY (ID) TEST STEP 2: TRACKING YOUR CANCER OVER TIME
IDENTIFY THE CANCER’S UNIQUE DNA BARCODES

To get started with clonoSEQ testing, your doctor will send a bone marrow sample taken at diagnosis to the Adaptive Biotechnologies lab in Seattle, Washington. If you have already started treatment, Adaptive can work with your doctor to retrieve a stored sample. This sample will then be used to identify the unique DNA barcodes associated with your cancer. This is called the Clonality (ID) Test.

USE THE DNA BARCODES IDENTIFIED IN THE CLONALITY (ID) TEST TO TRACK DISEASE OVER TIME

Once the initial identification step is complete, your doctor will take follow-up samples during treatment and remission to determine if any cancer is detectable, as well as how the amount of cancer may have changed over time. To do this, clonoSEQ compares the unique DNA barcodes identified in your initial Clonality (ID) Test to those found in later samples. These are called Tracking (MRD) Tests.

Understanding the clonoSEQ report

MRD testing is a powerful tool to help you and your doctor better understand your cancer, assess your response to treatment, track your disease over time, and potentially detect early signs of returning disease.[2] clonoSEQ tests provide straightforward results that may help inform the next step in your treatment plan.

Adaptive Biotechnologies delivers a report summarizing your clonoSEQ results to your doctor in approximately 7 to 14 days from the date your sample is received and accepted by our lab. clonoSEQ results should be used along with clinical examination, your medical history, and other test results and findings. Be sure to talk with your doctor about the optimal timing for clonoSEQ testing based on the type of blood cancer you have and your specific treatment plan.

clonoSEQ reports include the following information:

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MRD Status

A positive (+) result means residual disease was detected. A negative (-) result means residual disease was not detected. Each report will provide your updated MRD status. False positive or false negative results may occur for reasons including, but not limited to: contamination, technical, and/or biological factors. Talk to your doctor about your MRD status to better understand what a positive or negative result means for you and your treatment plan.

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MRD Level

This is the number of cancer-related DNA “barcodes” detected in your sample. This number tells your physician how much disease is present in your sample at that point in time. Your doctor can help put this number into context based on your current phase of treatment and therapeutic goals.

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MRD Trend

A simple graph will show any changes detected in your MRD level over time. Watching these changes will help you and your doctor better understand your response to treatment, track changes in your disease over time, and potentially detect early signs of returning disease.[2]

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CLONOSEQ PATIENT BROCHURE
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CLONOSEQ PATIENT JOURNEY
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Pat Resources 3 F6629713
UNDERSTANDING CLONALITY BROCHURE
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Making Connections

There are many organizations working to help patients and caregivers learn about blood cancers, treatments, and diagnostic tools. These groups are great resources to learn more about cancer and to connect with other patients.


This page is intended for use by patients and caregivers of the United States.

clonoSEQ® is an FDA-cleared test used to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is also available for use in other lymphoid cancers as a CLIA-validated laboratory developed test (LDT) service.

clonoSEQ is only available by prescription from a licensed healthcare professional. Results may vary. Talk to your healthcare provider to see if clonoSEQ testing is right for you. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

Citations

  1. Pulsipher M, et al. Blood. 2015;125(22):3501-8.
  2. clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary.
  3. Sherrod A, et al. Bone Marrow Transplant. 2015;51:2-12.
  4. NCI Dictionary of Cancer Terms: Complete Remission. National Cancer Institute. Accessed November 17, 2017.