Precision NGS MRD testing with clonoSEQ^®

MedGenome brings precise technology for MRD testing in India in collaboration with Adaptive Biotechnologies™

Precision NGS MRD testing with clonoSEQ

The clonoSEQ^® Clonality (ID) Test identifies trackable immune receptor DNA sequence(s) associated with a lymphoid malignancy. Diagnostic (pre-treatment) samples are typically used, but other samples with high disease burden (e.g., relapse) are also acceptable.

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More about clonoSEQ

With state-of-the-art MRD assessment, what gets measured gets managed.^®

Sensitivity
Detect MRD at low levels that correlate with patient outcomes: a single cancer cell among a million healthy cells, given sufficient sample input. This offers prognostic value to clinicians as they assess how patients respond to treatment.^1,2
Specificity
Precisely identify and quantify tracked malignant cells. Once the DNA sequences of the B- or T-cell receptors associated with these cancer cells are identified, the level of each specific sequence can be assessed in subsequent MRD samples.¹
Standardization
Ensure consistency and reproducibility of results for patients over time. clonoSEQ has undergone extensive analytical and clinical validation, fulfilling requirements for U.S. Food and Drug Administration (FDA) clearance for in vitro diagnostic use.^1,2

How clonoSEQ works

Precisely identifying MRD at the DNA sequence level

Each B- or T-cell receptor is coded by unique DNA sequences made of 3 segments—Variable, Diversity, and Joining—that serve as DNA “barcodes” that can be used to track malignant cells.^1,3

Ordering clonoSEQ

To order clonoSEQ, request your order from a MedGenome representative. Please call 1800 103 3691.

clonoSEQ Clinical Reports

Clinicians receive clonoSEQ test results via an informative clinical report. clonoSEQ reports are delivered to MedGenome via secure online portal, along with an opt-in email notification to alert the Clinician / MedGenome representative when the new report is available.

Clonality (ID) Report
Identifies trackable DNA sequence(s) associated with malignancy in a fresh or archived high disease load sample collected at the time of diagnosis or relapse.
The Clonality (ID) Report is the first report that a clinician receives upon initiating clonoSEQ testing for a new patient. This report indicates whether one or more trackable sequences has been identified for the patient, thus enabling subsequent MRD testing.
Tracking (MRD) Report
Quantifies and tracks minimal residual disease (MRD) during or after treatment in a freshly drawn bone marrow, peripheral blood, or plasma sample.*
Each Tracking (MRD) report includes the results from previous reports, providing a visual representation of changes in disease burden over time.

* Testing for validated sample types other than bone marrow (in B-ALL, myeloma, CLL) and peripheral blood (in CLL) is available via Adaptive’ s CLIA-regulated LDT service. Other sample types have not been cleared or approved by the FDA.

clonoSEQ Reports

clonoSEQ Clinical Reports One Pager for India

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Key Resources

References

clonoSEQ^®. [technical summary]. Seattle, WA. Adaptive Biotechnologies; 2020. https://www.clonoseq.com/technical-summary/
Ching T, et al. BMC Cancer. 2020;20:612.
Abbas A, et al. Cellular and Molecular Immunology. 9th ed. Elsevier; 2018.

clonoSEQ is available as an in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect minimal 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). Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). clonoSEQ is only available by prescription from a licensed healthcare professional. For important information about clonoSEQ including test limitations, please visit www.clonoSEQ.com/technical-summary.

The clonoSEQ Assay is not approved by the Drug Controller General of India (DCGI) for diagnostic use. The clonoSEQ Assay is available as an FDA-cleared in vitro diagnostic (IVD) or a CLIA-validated laboratory developed test (LDT) as a single-site assay performed at Adaptive Biotechnologies Corporation™ in Seattle, Washington, USA. This content is for the clinician’s reference use only.