Now FDA-cleared for CLL, Multiple Myeloma, and B-ALL
Monitor residual disease with clonoSEQ, FDA-cleared for MRD assessment in bone marrow from patients with multiple myeloma or B-ALL and blood or bone marrow from patients with CLL. clonoSEQ is covered by Medicare for patients with CLL, B-ALL or multiple myeloma. View the Technical Summary.
Answers that enhance clinical insight
Clear results with robust supporting data
Clinicians receive clonoSEQ® test results via an informative clinical report. These visually engaging reports provide clinicians with a clear MRD test result while also incorporating rich, quantitative data and comprehensive analysis for clinicians who want to dig deeper.
Results delivered via secure online portal
All reports are delivered via a secure web portal, which provides convenient access to patient results when needed.
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Explore example clonoSEQ reports:
The Clonality (ID) Test is used to identify dominant DNA sequences in a high disease load diagnostic sample.
Identification of at least one dominant DNA sequence is a prerequisite to future monitoring of MRD. After the dominant DNA sequences has been identified utilizing the Clonality (ID) Test, subsequent monitoring of the associated clone(s) can be completed by ordering Tracking (MRD) Tests.
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Page 1/3
Page 1 of the report shows that dominant DNA sequences were identified from the submitted sample.
A more detailed description of the results for this sample can be found in the “Results Summary” section.
A summary of the criteria used to determine which DNA sequences are dominant and thus can be followed as markers of malignancy is provided at the bottom of the page for reference.
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Page 2/3
Page 2 of the report shows detailed information relating to the sample including the actual rearranged DNA nucleotide sequence or sequences identified, the sample collection date, the receptor locus in which each dominant sequence was found, the specimen type analyzed, the frequency of the dominant sequence as a fraction of the total nucleated cells assessed, and the total number of cells carrying the rearranged DNA sequence.
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Page 3 of the report provides more details on the immune repertoire of the analyzed sample, including the sample clonality, the number of sequences assessed for each locus, and the number of unique sequences assessed.
The clonoSEQ B-cell Tracking (MRD) Report provides results based on analysis of the IgH, IgK and IgL loci as well as Bcl1 and Bcl2 translocations.
After the dominant DNA sequences has been identified utilizing the Clonality (ID) Test, subsequent monitoring of the associated clone(s) can be completed by ordering Tracking (MRD) Tests throughout treatment.
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In this sample, residual disease (MRD) was detected by the clonoSEQ Assay. This is indicated by the “plus” sign as well as the language stating “Residual Sequences Detected” in the blue box on page 1 of the report.
Further down the page, the Results Summary states the actual number of sequences observed by the assay and the total number of nucleated cells assessed in the sample.
In the bottom third of the page, a chart provides a longitudinal view of the sample-level MRD result for the current sample as well as for past samples sent for clonoSEQ testing for this patient.
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Page 2/4
Page 2 of the report shows detailed information relating to the current and previous samples including the actual rearranged DNA nucleotide sequence or sequences identified, sample collection dates the receptor locus which each dominant DNA sequence was found, the specimen type analyzed, the estimated sequence abundance (i.e., the number of residual clonal cells per million nucleated cells), and the 95% confidence interval for each MRD result.
A blue bar will be placed next to one of the sequences listed on this page to indicate that it is the sequence determining the MRD result for the current sample.
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Page 3/4
Page 3 of the report displays the sequence-level information from Page 2 in a chart format. This “sequence-level MRD” chart provides a longitudinal view of results for each individual tracked sequence.
In addition to the sequence-level chart, this page lists the criteria used by the clonoSEQ Assay to define dominant sequences, as well as a summary of the assay method and limitations.
The appendix provides more details on the immune repertoire of the analyzed sample, including the sample clonality, the number of sequences assessed for each locus, and the number of unique sequences assessed.
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Page 4 of the report continues details on the immune repertoire of the analyzed sample, noting the limit of detection and limit of quantitation for each sequence tracked.
A glossary of terms and references relevant to the report is also provided on this page.
Within the glossary, the assay’s limit of blank, which is zero, is stated and defined.
This page is intended for use by healthcare professionals of the United States.
clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies 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/technical-summary.
Explore clonoSEQ clinical reports in more depth
Download a comprehensive guide to the reports that will walk you through each section in detail.
View PDFQuestions about clonoSEQ reports?
Adaptive’s Clinical Services and Clinical Consultant teams provide clinicians with support throughout the clonoSEQ testing process and offer unmatched expertise in the field of residual disease assessment.[2-4] Their goal is to provide a seamless user experience, empowering clinicians with timely results that can inform their treatment decisions.
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Citations
- clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary.
- 42 CFR § 493.1417
- MD, DO, or DPM with a current medical license
- Doctoral degree in chemical, physical, biological or clinical laboratory sciences with certification by a board approved by HHS.