PRODUCTS

Minimal Residual Disease (MRD)

MRD is the presence of low levels of malignant cells that remain in a subject during or after treatment or when the patient is in remission.  Detectable levels of cancer cells following treatment may suggest a higher probability of relapse.

PRODUCTS

Minimal Residual
Disease
(MRD)

MRD is the presence of low levels of malignant cells that remain in a subject during or after treatment or when the patient is in remission.  Detectable levels of cancer cells following treatment may suggest a higher probability of relapse.

MRD Solutions

LabPMM services include MRD tracking of targeted mutations including FLT3 ITD and NPM1, or LymphoTrack® enabled Ig/TR rearrangement detection.  Invivoscribe product offerings include the LymphoTrack® portfolio of solutions for MRD tracking of B-cell/T-cell clonality.

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MRD Solutions

LabPMM services include MRD tracking of targeted mutations including FLT3 ITD and NPM1, or LymphoTrack® enabled Ig/TR rearrangement detection.  Invivoscribe product offerings include the LymphoTrack® portfolio of solutions for MRD tracking of B-cell/T-cell clonality.
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WHY IT MATTERS

MRD Clonotype Testing Can Save Lives.

Residual leukemic cells that remain in the bone marrow following treatment are a major cause of disease relapse and can also act as an early indicator to the effectiveness of a given treatment strategy. Recent treatment advances have led to significantly increased clinical response and overall survival, but ultimately most subjects will relapse, driving the need for sensitive MRD monitoring.

Early detection of disease evolution or recurrence typically provides the highest probability of eradicating cancer. Moreover, studies have found that the level of MRD clonotypes found in bone marrow or peripheral blood samples correlate with the probability of disease recurrence. MRD negativity may offer significantly improved clinical outcomes and has been found to be more predictive of overall survival than complete response (CR). Sensitive and standardized testing such as NGS-based MRD may one day enable identification of those cases that will eventually relapse versus those who are potentially cured.

[Capana, Dario et al. Blood (2012) 120:5172-5180.]

WHEN TO TEST FOR MRD CLONALITY

MRD testing may optimize therapeutic management of lymphoproliferative disease.

Following initial induction, it is imperative to continuously monitor and accurately trend disease burden. NCCN guidelines suggest that MRD testing may be used to assess the effectiveness of treatment and to monitor for recurrences of malignant clonotypes during remission. MRD can also help detect refractory cancer when multiple clonotype sequences are tracked.

Increasingly, MRD can be used not only to monitor tumor burden in subjects, but as a surrogate endpoint for clinical trials because it can help standardize testing, collapse timelines and expedite drug approvals.
MRD TEST METHODS

NGS-based MRD clonality testing offers key benefits over alternate methods as it is sensitive and objective, easy to standardize, and can be used to track multiple clonotypes simultaneously.

Alternate methods of monitoring MRD include allele specific oligonucleotide polymerase chain reaction (ASO-PCR) and multi-parameter flow cytometry. However, new studies suggest that more sensitive methods such as NGS are needed to better predict outcomes. Moreover, test standardization is important to lab throughput and turn-around-time. Unfortunately, ASO-PCR based MRD testing requires custom primer sets, which increase turn-around-time while decreasing test standardization.

Multi-parameter flow cytometry may also be utilized for MRD clonality testing as it can provide good sensitivity, is inexpensive, and can be used to track multiple immunophenotypes. However, current flow cytometry-based MRD methods are highly subjective and recommendations are often based on consensus expert-shared knowledge and experience, not on a validated, objective method. Accordingly, NGS powered solutions are optimal for sensitivity, objectivity and high throughput standardization.
A NEW INVIVOSCRIBE SOLUTION

LymphoTrack® MRD Bundled Solution
Powerful NGS Assays and Controls for MRD Clonality Testing.

Invivoscribe offers state-of-the-art NGS-based LymphoTrack Clonality Assays*, LymphoTrack® MRD Low Positive Controls, LymphoQuant® Internal Controls, and bioinformatics LymphoTrack MRD software designed for the study of MRD across IGH, IGK, TRG and TRB gene targets. MRD testing by Next-Generation Sequencing (NGS) offers enhanced sensitivity, specificity and objectivity, allowing investigators to monitor and track measurable residual disease through the entire course of a study.

As part of the LympoTrack MRD Solution, LymphoTrack® Low Positive Controls are used as an external quality control for each run, while the LymphoQuant® Internal Controls are used as an internal control to be spiked into each sample. These RUO DNA controls are developed for use with LymphoTrack® Assays and LymphoTrack® MRD software to track clonal sequences on MiSeq®, Ion S5™ and Ion PGM™ platforms. The LymphoTrack® MRD Bundled Solutions* are offered for T- or B-Cell assessment and allow researchers to accurately detect and trend clonal evolution in longitudinal studies in their own laboratories, with unprecedented simplicity.

LymphoTrack® MRD NGS

NGS Powered Assays, Controls & Software for Longitudinal MRD Testing

The RUO T-cell MRD Bundle includes:

The RUO B-cell MRD Bundle includes:

* LymphoTrack MRD Bioinformatics Software

  • Proprietary standalone software enables trending over time.
  • Includes a module to design experiments that can detect as little as one cancer cell in one million healthy cells (with sufficient DNA input).
  • Claim MRD negativity with the desired level of confidence.
  • Representative graph will be included in the upcoming software version.

Create a tailored NGS Solution to assess MRD. Consult with our hematology oncology specialists.

*MRD testing with the LymphoTrack MRD Bundled Solution with the LymphoTrack® Low Positive Control, LymphoQuant® Internal Control and LymphoTrack® MRD Software is for Research Use Only (RUO). Not for use in diagnostic procedures.
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