FDA Approves First Next-Generation Sequencing Test for Minimal Residual Disease of ALL and Multiple Myeloma

On September 28, 2018, the U.S. Food and Drug Administration (FDA) approved the first next-generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma (MM). The test is called ClonoSEQ assay and will measure the amount of cancer cells remaining in a person’s bone marrow, called minimal residual disease or measurable residual disease.^1,2

What is next-generation sequencing?

When the human genome was first sequenced, it took over a decade. In contrast, next-generation sequencing (NGS) allows for genetic information to be processed with significantly faster speed and improved accuracy. (Using NGS, an individual’s human genome can be delivered within a single day.)³

How is next-generation sequencing used in blood cancer?

Cancers begin due to mutations, or changes in the DNA of the cells, which causes the cells to multiply out of control. In blood cancer, the growth and abundance of cancer cells often reduces the number of healthy blood cells in the body, which can cause problems such as anemia (too few red blood cells), increased risk of bleeding or bruising (due to too few platelets), and increased risk of infections (due to too few white blood cells).

With NGS, cancer genomes can be sequenced. In some forms of cancer, identification of specific mutations can provide more information on prognosis, classification of the disease, and may help determine treatment options.³

Why is the ClonoSEQ assay important?

With the ClonoSEQ assay, doctors will be able to determine whether a person with ALL or MM has cancer cells remaining after treatment or to detect a return of the cancer at its earliest stages. This can better help doctors determine next steps for people with ALL or MM and better manage their care.^1,2

Minimal residual disease (MRD) is a measure of the amount of cancer in the body, even at very low levels. At low levels, the cancer cells may not cause any physical symptoms, but they can be a sign that the cancer is returning or has not responded completely to treatment. The level of MRD is correlated with the length of time a patient is in remission. The currently available tests, which use flow cytometry assays or polymerase chain reaction (PCR)-based assays, are capable of measuring MRD down to 1 in 10,000 or 1 in 100,000 cells.¹

Using a sample from the bone marrow, the ClonoSEQ assay uses multiple PCR and next-generation sequencing to identify and count specific gene sequences in the DNA of an individual with ALL or MM. The ClonoSEQ assay can detect MRD at levels below 1 in 1 million cells, providing significantly more accuracy than previous tests.¹

The ClonoSEQ assay is marketed by Adaptive Biotechnologies. It is available by prescription only. Talk to your doctor about whether ClonoSEQ is right for you.