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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.
CLONALITY (ID) REPORT
The Clonality (ID) Report provides an overview of the dominant DNA sequence(s) identified in a patient sample collected during diagnostic workup. These dominant sequences are typically associated with malignancy and will be used by the clonoSEQ® Assay as the basis for MRD detection.
The Clonality (ID) Report is the first report that a clinician receives upon initiating clonoSEQ testing for a new patient.
TRACKING (MRD) REPORT
The Tracking (MRD) Report summarizes results from MRD testing of patient samples collected during or after treatment. Tracking (MRD) Reports assess and quantify the presence of each tracked DNA sequence and identify newly-emerging dominant DNA sequences. Since clinicians often assess residual disease repeatedly during the course of a patient’s treatment or remission, many patients will receive multiple Tracking (MRD) Reports over time. Each report includes the results from previous reports, providing a visual representation of disease burden over time that clinicians can map to treatment cycles and easily communicate to patients.
Report content tailored to inform decisions
Explore example clonoSEQ reports:
The Clonality (ID) Test is used to identify dominant DNA sequence(s) 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.
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.
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.
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 sequence(s) 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.
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 Sequence(s) 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.
At the top of page 2, 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.
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.
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.
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 outside of the United States.
The clonoSEQ Assay B-cell Reagent Set is an in vitro diagnostic that identifies and quantifies rearranged B-cell receptor gene sequences in DNA extracted from blood and bone marrow.
It is a manual test that determines measurable/minimal residual disease (MRD) and monitors changes in disease burden during and after treatment in B-cell malignancies. The test is indicated for use by qualified healthcare professionals for clinical decision-making and in conjunction with other clinicopathological features.
The clonoSEQ Assay is being utilized for a variety of investigator-sponsored clinical trials in B-cell lymphoid cancers. If you are interested in learning more about use of clonoSEQ in your own trials, contact firstname.lastname@example.org.
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- The clonoSEQ Assay B-Cell Reagent Set is CE marked as in vitro diagnostic (IVD) for assessing the MRD status and changes in disease burden during and after treatment in B-Cell malignancies in DNA extracted from blood and/or bone marrow samples.