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. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com.
Minimal (or measurable) 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.
The clonoSEQ® (pronounced clo-no-seek) Assay is the first and only FDA-cleared test that detects, counts, and tracks MRD in multiple myeloma patients using bone marrow samples. 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 to inform the next step in your treatment plan.
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.
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. Together, you and your healthcare team can keep a watchful eye on MRD trends and use them to inform important treatment decisions.2
First, 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.
Next, your doctor will take bone marrow 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 taken during or after treatment. These are called Tracking (MRD) Tests.2
clonoSEQ results should always be used in combination with clinical examination, your medical history, and other test results and findings. Talk with your doctor about the optimal timing for clonoSEQ testing based on your specific treatment plan.
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.2
Knowing how much cancer may still be present in your body allows your physician to tailor your treatment plan to better help fight your disease.
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 it may be changing over time.
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.
clonoSEQ tests provide straightforward results to inform the next step in your treatment plan. A report summarizing your results will be delivered directly to your physician approximately 7 to 14 days after your sample is received and accepted by the Adaptive Biotechnologies lab.
clonoSEQ reports provide three key types of information: MRD status, MRD level, and MRD trend.
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.
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.
This 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.
Gathering as much information as you can about your multiple myeloma is key to playing an informed role in your treatment decisions. The following link will help by providing an overview of measurable residual disease (MRD) and how clonoSEQ testing is used to assess and track MRD over time.
Adaptive identifies, counts, and tracks measurable residual disease (MRD) over time to provide reports to your physician that help inform your personalized treatment plan.
Use this tool to locate a physician who has experience with clonoSEQ MRD testing and can help you take the next steps in the patient journey.
Adaptive Biotechnologies understands that each patient's situation is unique. That's why we offer the Adaptive Assist program: to help facilitate access to clonoSEQ testing services for patients who could benefit from the clinical insights provided by next-generation MRD testing.