Technical Information

B-cell MRD Assay
CAP/CLIA-Validated

Clinical SignificanceCombinations of radiation, chemotherapy and bone

Key Benefits
1x10-6 sensitivity allows earlier detection of disease

marrow transplantation are potentially curative for several

relapse and evolution

hematologic malignancies. However, in some patients, occult

Accelerates drug development and exploratory

tumor cells exist and are thought to increase the patient’s risk

endpoint studies

of relapse.¹ These subclinical levels of residual cancer cells
are termed measurable or minimal residual disease (MRD)and can be evaluated using highly sensitive assays.
Tracking antigen-receptor gene rearrangements for clonality
and MRD can be applied to virtually all patients.
Cancer cells that arise from alterations in single lymphoid
precursors acquire clonal IGH junctional regions, which can

Test the same primary sample with NGS andmutiparametric flow cytometry
Available at LabPMM San Diego, CA; coming soon
to Shanghai, China

Indications for Testing

be used as tumor-specific markers.2,3 NGS-based MRD

Identify and track tumor-specific sequences for B-cellassays can generate prognostic and clinically actionable

proliferations

information. Studies have shown that highly sensitive NGS
assays can detect MRD up to 6 months before traditional
methods4 which allows early intervention, confirmation

NCCN Guidelines (v5.2022) Multiple Myeloma suggest
MRD assessments to evaluate:of disease status prior to transplant, and increased

Disease status prior to transplantconfidence in remission status.

Following induction, high-dose therapy/ASCT,
consolidation and maintenance therapy
Optimize treatment strategies

NextSeq TM 550Dx

Monitor and evaluate for refractory and relapsed disease

Associated Diseases
Multiple Myeloma (MM)Chronic Lymphocytic Leukemia (CLL)
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Diffuse Large B-cell Lymphoma (DLBCL)
Mantle Cell Lymphoma (MCL)
Courtesy of Illumina, Inc.

References
1. Rezuke, WN et al. (1997) Clinical Chemistry. 43:1814-23.
2. Gazzola, A et al. (2014) Therapeutic Advances in Hematology. 5:35-47.
3. González, D et al. (2007) Blood. 110:3112-21.
4. Cheng, S et al. (2018) Journal of Hematology & Oncology. 11(1):105.

M-0091 Rev 01 May 2022

Plasma Cell Neoplasms (PCN)
Follicular Lymphoma (FL)
Marginal Zone Lymphoma (MZL)w w w. i n v i v o s c r i b e .c o mTechnical Information

MethodClonal B-cell gene rearrangement sequences identified at diagnosis, will be tracked in post-treatment follow-up samples for(MRD) status. The conserved framework region 1 (FR1) or framework region 3 (FR3) and joining region is targeted by a multiplex
master mix for PCR amplification. The PCR products are then sequenced on a NextSeqTM 550Dx to identify and track FR1 or FR3
clonal sequences previously identified at diagnosis. Bioinformatics tools facilitate the detection of these specific sequences
present at MRD levels of 1x10 -6 with sufficient DNA input.
This assay requires a sample taken at diagnosis as well as follow-up samples. If the patient has previously been tested byLabPMM for IGH clonality, no diagnostic sample is needed.

Clinical Performance
Clonal MRD Frequency vs. Expected MRD Frequency
IGH FR1 Performance using 0.5, 2 and 20 µg DNA Input

IGH FR3 Performance using 0.5, 2 and 20 µg DNA Input

Clonal MRD Frequency vs. Expected MRD Frequency

Clonal MRD Frequency vs. Expected MRD Frequency

1e-7
1e-7

Calculated MRD Freq

R²: 0.927

1e-7

1e-7

R2: 0.927

R2: 0.817

Calculated MRD Freq

Clonal MRD

1e-6
1e-6

1e-6

Clonal MRD Frequency

1e-6

Clonal MRD Frequency

Clonal MRD

R²: 0.817

1e-5

1e-5

1e-4

1e-4

1e-3

1e-5
1e-5

1e-4
1e-4

1e-3
1e-3

1e-3

1e-2

1e-2
1e-2

1e-2

1e-2

1e-2

1e-3

1e-3

1e-4

1e-5

1e-4
1e-5
Expected MRD Frequency
Expected MRD Frequency

1e-6

1e-2

1e-7

1e-6

1e-7

1e-3

1e-2

1e-3

1e-4

1e-5

1e-4

1e-5

Expected MRD Frequency

1e-6

1e-6

1e-7

1e-7

Expected MRD Frequency

Diseases:

CLL

MCL

MM

Specimen Requirements
Interpretation
An interpretive reportwill be issued indicating
whether IGH MRD
was detected.

TurnaroundTime

Specimen
Requirements

Shipping
Conditions

Specimen
Stability

14 to 21
business days

1-2 mL of peripheral bloodin EDTA or Heparin

Peripheral blood
ambient or cool; do not freeze

15 to 30 °Cfor up to 3 days

1-2 mL of bone marrow
in EDTA or Heparin

Bone marrow**ambient, cool or frozen on dry ice

2 to 8 °C
up to 7 days

0.5 - 20 µg of previously
isolated DNA depending onlevel of sensitivity required*

Isolated DNA ambient or frozen
on dry ice-15 to -30 °C
for up to 3 months* If less than 20 µg is provided, the sensitivity of the assay may be impacted.
** Ambient bone marrow may limit the sensitivity that can be achieved.

LabPMM, LLC
10222 Barnes Canyon Rd. | Building 1 | San Diego, CA 92121, USA
inquiry@invivoscribe.com | Tel +1 858.224.6600 | Fax +1 858.224.6601

LabPMM GmbH
Zeppelinstraße 1 | 85399 Hallbergmoos (Munich Area), Germany
inquiry@invivoscribe.com | Tel +49 89 904 299 800 | Fax +49 89 921 857 48w w w. i n v i v o s c r i b e .c o m