ABOUT MINIMAL RESIDUAL DISEASE (MRD)
MRD is increasingly being
used to inform treatment decisions, making MRD test selection
- Minimal, or measurable, residual
disease (MRD) refers to the small number of cancer cells that can
remain in a patient’s body during and after treatment, often
causing no physical signs or symptoms, and that may result in
- With the variety of new treatment
options that are becoming available for blood cancer patients,
clinicians are eager to have as much information as possible to
help them decide the most appropriate course for each patient.
- What we are seeing is a shift in
which MRD is replacing traditional primary endpoints such as
progression-free survival (PFS) in clinical trials.1
- As technologies for MRD detection
have improved, physicians have been able to detect increasingly
smaller amounts of disease, and in myeloma for example, controlled
trials have shown that even these small amounts of disease matter
when it comes to predicting a patient’s long-term clinical
- Selection of an appropriate MRD test
becomes even more important when you consider clinicians now have
access to an approved, MRD-directed therapy.3
MRD testing is an essential component of clinical
practice guidelines for lymphoid malignancies like multiple myeloma and
acute lymphoblastic leukemia (ALL).
- For myeloma patients, the NCCN® Guidelines and IMWG Consensus
Criteria recommend MRD assessment using a validated assay after
each treatment stage.4,5
- For ALL patients, the NCCN® Guidelines recommend MRD assessment
after completion of initial induction and at additional time
points depending on treatment regimen. The guidelines also call
for baseline characterization of the leukemic clone to facilitate
subsequent MRD analysis.6
ABOUT THE CLONOSEQ® ASSAY
clonoSEQ, is a
highly-accurate, sensitive, and standardized MRD test to help predict
patient outcomes, assess treatment response, monitor disease burden
over time, and detect signs of returning disease.2,7,8,9,10
- clonoSEQ is a next-generation
sequencing (NGS)-powered test that detects, quantifies, and
monitors MRD in patients with lymphoid malignancies like multiple
myeloma and ALL.2,11
- Using the unique DNA sequences that
are associated with lymphocyte receptors for a specific patient,
clonoSEQ precisely identifies malignant cells, counts how many of
those cells are present in a patient’s bone marrow sample, and
then tracks those cancer cells over time.6,12
- clonoSEQ testing is already being
used at the majority of NCCN cancer centers (24 of 27) and usage
is expanding to referral centers and community practices.
clonoSEQ is the first and only FDA-cleared test for MRD
assessment in any lymphoid cancer.
- clonoSEQ has received FDA clearance
as an in vitro diagnostic (IVD) test service provided by Adaptive
Biotechnologies for use in B-cell ALL and multiple myeloma
patients to detect and monitor MRD in bone marrow samples.
clonoSEQ is also available for use in other lymphoid cancers as a
CLIA-regulated laboratory developed test (LDT) service provided by
- clonoSEQ results should always be
used in combination with clinical examination, patient medical
history, and other findings. Results may vary according to sample
time within the course of disease or by sampling site location.
important information about the FDA-cleared uses of clonoSEQ,
including test limitations, visit clonoSEQ.com/technical-summary
1. Clinicaltrials.gov search.
Outcome measure: minimal residual disease. 2018.
2. Martinez-Lopez J, et al. Blood.
3. FDA; (2018). FDA expands approval of Blincyto
for treatment of a type of leukemia in patients who have a certain risk
factor for relapse. [online] Available at:
[Accessed 7 July 2018].
4. NCCN Clinical Practice Guidelines in Oncology®: Multiple Myeloma.
5. Kumar S, at al. Lancet Oncol.
6. NCCN Clinical Practice
Guidelines in Oncology®: Acute Lymphoblastic Leukemia. Version 1.2018.
7. Faham M, et al. Blood. 2012;120(26):5173-80.
(study author was an employee of Adaptive at time of publishing)
8. Data on file. Adaptive Biotechnologies. 2018.
9. Pulsipher M, et al. Blood.
10. Korde N, et al. JAMA Oncol. 2015;1(6):746-54.
11. Wood B, et al. Blood.
12. Carlson C, et al. Nat Commun. 2013;4:2680. (Research studies
were supported, in part, by Adaptive Biotechnologies)