MEASURABLE
RESIDUAL DISEASE (MRD)

MRD is the presence of low levels of malignant cells during or after treatment or during remission.  Detectable levels following treatment may indicate a higher risk of relapse.

MRD 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 testing.

Early detection of disease evolution or recurrence typically provides the highest probability of eradicating cancer. Moreover, studies have found that the level of MRD 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 (OS) than complete response (CR). Sensitive and standardized NGS-based MRD testing may one day enable identification of those cases that will eventually relapse versus those who are potentially cured.

Faham, M. et al. Blood (2012). 120(26):5173-5180

MRD testing may optimize therapeutic management of hematologic 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 mutations during remission. MRD testing can also help detect refractory cancer when multiple clonotype sequences are tracked.

Increasingly, MRD testing 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.

NGS-based MRD testing provides an easily standardized, objective methodology with high sensitivity that has proven useful in studies for prognosis and risk stratification. 

Traditional methods of monitoring MRD include allele specific oligonucleotide polymerase chain reaction (ASO-PCR) and flow cytometry.  These methods offer limited sensitivity, are difficult to standardize, can be highly subjective, and may require years of experience to correctly interpret.  However, use of next generation sequencing (NGS) methods to monitor MRD enables comprehensive clonal characterization and disease assessment, often superior to flow cytometry.

New studies suggest that more sensitive methods such as NGS can better predict outcomes. Moreover, test standardization is important for lab throughput and turn-around-time. Accordingly, NGS powered solutions are optimal for sensitivity, objectivity and high throughput standardization.

Medina, et al. Blood. 2017; 130 (17):1783-1801. 
Arcila, et al. Blood. 2017; 130 (Supplement 1):4017.

 

Powerful NGS Assays, Controls and Software for MRD Testing. 

Invivoscribe offers state-of-the-art NGS-based lymphoid and myeloid MRD services and in-house solutions. Our in-house comprehensive kits and bioinformatic software are designed to detect IGHIGKTRG, TRB, FLT3 ITD or NPM1 gene targets, allowing researchers to accurately detect and trend mutation evolution in longitudinal studies in their own laboratories, with unprecedented simplicity. MRD testing by NGS offers enhanced sensitivity, specificity and objectivity, allowing investigators to monitor and track residual disease through the entire course of a study.

MRD 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 testing.

Early detection of disease evolution or recurrence typically provides the highest probability of eradicating cancer. Moreover, studies have found that the level of MRD 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 (OS) than complete response (CR). Sensitive and standardized NGS-based MRD testing may one day enable identification of those cases that will eventually relapse versus those who are potentially cured.

Faham, M. et al. Blood (2012). 120(26):5173-5180

MRD testing may optimize therapeutic management of hematologic 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 mutations during remission. MRD testing can also help detect refractory cancer when multiple clonotype sequences are tracked.

Increasingly, MRD testing 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.

NGS-based MRD testing provides an easily standardized, objective methodology with high sensitivity that has proven useful in studies for prognosis and risk stratification. 

Traditional methods of monitoring MRD include allele specific oligonucleotide polymerase chain reaction (ASO-PCR) and flow cytometry.  These methods offer limited sensitivity, are difficult to standardize, can be highly subjective, and may require years of experience to correctly interpret.  However, use of next generation sequencing (NGS) methods to monitor MRD enables comprehensive clonal characterization and disease assessment, often superior to flow cytometry.

New studies suggest that more sensitive methods such as NGS can better predict outcomes. Moreover, test standardization is important for lab throughput and turn-around-time. Accordingly, NGS powered solutions are optimal for sensitivity, objectivity and high throughput standardization.

Medina, et al. Blood. 2017; 130 (17):1783-1801. 
Arcila, et al. Blood. 2017; 130 (Supplement 1):4017.

 

Powerful NGS Assays, Controls and Software for MRD Testing. 

Invivoscribe offers state-of-the-art NGS-based lymphoid and myeloid MRD services and in-house solutions. Our in-house comprehensive kits and bioinformatic software are designed to detect IGHIGKTRG, TRB, FLT3 ITD or NPM1 gene targets, allowing researchers to accurately detect and trend mutation evolution in longitudinal studies in their own laboratories, with unprecedented simplicity. MRD testing by NGS offers enhanced sensitivity, specificity and objectivity, allowing investigators to monitor and track residual disease through the entire course of a study.

Comprehensive Lymphoid & Myeloid Solutions 

L Y M P H O I D

Lymphoid malignancies are the 4th most common cancer in men and women, and include non-Hodgkin lymphoma, Hodgkin lymphoma, myeloma and lymphocytic leukemia.  These cancers originate in lymphocytes of the immune system and are caused by malignant transformation of normal lymphoid cells at various stages of differentiation.  Because they can invade lymph tissue past the basement membrane and connect to lymph nodes and vessels, lymphoid neoplasms are usually malignant by nature, allowing them to spread throughout the body.

Shaffer, et al.  Rev lmmunol.  2002; 2:920-933.
Longo, DL.  Haffison’s Hematology and Oncology, 3rd Ed, McGraw-Hill Education. 2016.
Alaggio, et al.  Leukemia.  2022;  36:1720-1748.

M Y E L O I D 

Myeloid malignancies include myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), MDS/MPN, and acute myeloid leukemia (AML). AML is a rapidly progressing heterogenous disease and characterized by the intrusion of bone and blood by proliferative cells of the hematopoietic system1 that are unable to differentiate or mature normally2,  resulting in a drop in healthy red and white blood cells. Though comprising only 1% of all new cancer cases, the five-year relative survival rate is only 31.9%.

1 Dohner et al. NEJM. 2015;373:1136-52.
2 Maeda Y. Int J Hematol. 2024;119(4):347-373.
3 https://seer.cancer.gov/statfacts/html/amyl.html. Accessed 08 July 2024.

Comprehensive Lymphoid & Myeloid Solutions 

L Y M P H O I D

Lymphoid malignancies are the 4th most common cancer in men and women, and include non-Hodgkin lymphoma, Hodgkin lymphoma, myeloma and lymphocytic leukemia.  These cancers originate in lymphocytes of the immune system and are caused by malignant transformation of normal lymphoid cells at various stages of differentiation.  Because they can invade lymph tissue past the basement membrane and connect to lymph nodes and vessels, lymphoid neoplasms are usually malignant by nature, allowing them to spread throughout the body.

Shaffer, et al.  Rev lmmunol.  2002; 2:920-933.
Longo, DL.  Haffison’s Hematology and Oncology, 3rd Ed, McGraw-Hill Education. 2016.
Alaggio, et al.  Leukemia.  2022;  36:1720-1748.

M Y E L O I D 

Myeloid malignancies include myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), MDS/MPN, and acute myeloid leukemia (AML). AML is a rapidly progressing heterogenous disease and characterized by the intrusion of bone and blood by proliferative cells of the hematopoietic system1 that are unable to differentiate or mature normally2,  resulting in a drop in healthy red and white blood cells. Though comprising only 1% of all new cancer cases, the five-year relative survival rate is only 31.9%.

1 Dohner et al. NEJM. 2015;373:1136-52.
2 Maeda Y. Int J Hematol. 2024;119(4):347-373.
3 https://seer.cancer.gov/statfacts/html/amyl.html. Accessed 08 July 2024.

LymphoTrack
NGS Solutions

Visualize the diversity of immunoglobulin (Ig) and T-cell receptor (TCR) gene rearrangements and identify somatic hypermutation. A simplified workflow makes implementing LymphoTrack Assays in your lab easy.

LymphoQuant &
LymphoTrack

MRD Controls
& Software

Identify and track multiple clonal gene rearrangements and detect newly emergent clones and sub-clones.  The LymphoTrack MRD Bundled Solution includes assay reagents, an internal control, a low positive control, and bioinformatics software.

FLT3 ITD MRD
Assay & Software

A comprehensive NGS assay that identifies and tracks FLT3-ITDs. Portable Linux-based software integrates into downstream systems and analyzes and reports data in under an hour.

NPM1 MRD
Assay & Software*

A comprehensive NGS assay that identifies and tracks NPM1 gene mutations. Portable Linux-based software integrates into downstream systems and analyzes and reports data within minutes.

These products are for Research Use Only (RUO); not intended for diagnostic purposes.  *To inquire about regional availability, please contact [email protected].

LymphoTrack
NGS Solutions

Visualize the diversity of immunoglobulin (Ig) and T-cell receptor (TCR) gene rearrangements and identify somatic hypermutation. A simplified workflow makes implementing LymphoTrack Assays in your lab easy.

LymphoQuant &
LymphoTrack

MRD Controls
& Software

Identify and track multiple clonal gene rearrangements and detect newly emergent clones and sub-clones.  The LymphoTrack MRD Bundled Solution includes assay reagents, an internal control, a low positive control, and bioinformatics software.

FLT3 ITD MRD
Assay & Software

A comprehensive NGS assay that identifies and tracks FLT3-ITDs. Portable Linux-based software integrates into downstream systems and analyzes and reports data in under an hour.

NPM1 MRD
Assay & Software*

A comprehensive NGS assay that identifies and tracks NPM1 gene mutations. Portable Linux-based software integrates into downstream systems and analyzes and reports data within minutes.

These products are for Research Use Only (RUO); not intended for diagnostic purposes.  *To inquire about regional availability, please contact [email protected].

Empowering Clinicians to Make The Best Treatment
Decisions With Their Patients

PRECISION MEDICINE

The LeukoStrat® CDx FLT3 Mutation Assay is an IVD companion diagnostic to aid in the selection of acute myeloid leukemia patients eligible for treatment  with VANFLYTA®, RYDAPT®, and/or XOSPATA®.

LABORATORY FOR PERSONALIZED
MOLECULAR MEDICINE® 

No lab? No problem. Our Laboratory of Personalized Molecular Medicine (LabPMM®) offers internationally standardized testing of clinically important biomarkers. Ensure the best for your patient with our companion diagnostic, NGS and MFC panels and targeted assays identifying gene mutations, MRD and clonality services.

Empowering Clinicians to Make The Best Treatment
Decisions With Their Patients

PRECISION MEDICINE

The LeukoStrat® CDx FLT3 Mutation Assay is an IVD companion diagnostic to aid in the selection of acute myeloid leukemia patients eligible for treatment  with VANFLYTA®, RYDAPT®, and/or XOSPATA®.

LABORATORY FOR PERSONALIZED
MOLECULAR MEDICINE® 

No lab? No problem. Our Laboratory of Personalized Molecular Medicine (LabPMM®) offers internationally standardized testing of clinically important biomarkers. Ensure the best for your patient with our companion diagnostic, NGS and MFC panels and targeted assays identifying gene mutations, MRD and clonality services.