Accelerate Drug Development

LabPMM® Global Network

State-of-the-art multiparametric flow cytometry (MFC) assays
are highly sensitive, fast and cost-effective. Our internationallyharmonized MFC assays are designed based on 2018 ELN
MRD Working Party Consensus,8 2006 Bethesda Consensus9and 2017 WHO Classification Guidance.10

The Laboratory for Personalized Molecular Medicine®
(LabPMM®) offers standardized testing of novel andproprietary biomarkers across an international networkof clinical labs.

GLOBALLY STANDARDIZEDMULTIPARAMETRICFLOW CYTOMETRY ASSAYS

Our MFC services provide powerful analytic tools to:Stratify patients for enrollment based on
immunophenotypic profiles
Predict therapy efficacy for program prioritization
by monitoring response

Identify, Stratify and Monitor Hematologic Malignancies

Expedite clinical trials by serving as surrogate endpoints

Global Reach

Fast-track clinical trial enrollment using the LabPMM
network to provide internationally standardized testing with
CLIA, CAP and ISO 15189 certifications.

Regulatory Expertise

Our experienced team has over 50 product registrations andcompanion diagnostic approvals in the US, EU, and Japan.

Custom Product Development

Leverage nearly 30 years of assay development experienceto accelerate drug approvals. Custom assays are designed
and manufactured under an ISO certified quality
management system.

LabPMM, LLC
10222 Barnes Canyon Rd, Bldg. 1 | San Diego | CA 92121 | USA
Phone: +1 858.224.6650 | Fax: +1 858.224.6655
Email: support@labpmm.com

LabPMM, GmbH
Zeppelinstraße 1 | 85399 Hallbergmoos | Germany
Phone: +49 (0) 89 904299800 | Fax: +49 (0) 89 92185748
Email: inquiry@invivoscribe.com

LabPMM, GK

Talk to our scientists to learn more:invivoscribe.com/contact

Life Science & Environment Research Center (LiSE) 4th Floor
3-25-13 Tonomachi | Kawasaki-ku
Kawasaki-shi | Kanagawa 210-0821 | Japan
Phone: +81 (0)44 281.1500 | Fax: +81 (0)3 6745.9346
Email: services@labpmm.co.jp

Invivoscribe Diagnostic Technologies (Shanghai) Co., Ltd.
Unit 6302, #6 Bldg., 338 Jia Li Lue Road | Zhangjiang Hi-Tech Park
Pu Dong District | 201203 Shanghai | China
Phone: +86 21 6162 9669
Email: sales@invivoscribe.com

A CLIA-certified/CAP Accredited International Laboratory NetworkDiagnosis and Stratification

MRD as a Surrogate Endpoint

Prognostication and Tracking

Hematologic malignancies (HMs) account for approximately
6.5% of all cancers, and are the fourth most frequently
diagnosed cancer in economically developed countries.1,2Over the past decade, the number of clinical trials targeting
HMs has increased at a rapid rate,3 perpetually changing
the diagnostic and therapeutic paradigm.

While the overall incidence of leukemia has declined, ratesof Acute Myeloid Leukemia (AML) and Chronic Lymphocytic
Leukemia (CLL) are increasing, accounting for nearly 40%of total leukemia cases worldwide.4 Fortunately, a plethoraof agents have recently entered the market, some targeting
specific mutations or cell survival signal pathways5 and otherstrategies using CAR-T cells6 and immune checkpoint
inhibitors7—all of which require confirmation of treatment
response.

Globally, CLL has increased by approximately 7% over the past
30 years, with a higher incidence among men and adults over
65.4,11 Furthermore, CLL is the most prevalent type of leukemia,
comprising of 25% - 30% of all leukemias in Western
populations.1Hematolymphoid Screening Panel

A comprehensive approach to evaluate bone marrowand peripheral blood for hematolymphoid malignancies.
Provides a wide array of applications due to its
comprehensive biomarker selection
Evaluate Acute Leukemia, plasma cell dyscrasias,NK, B- and T-cell disorders
Biomarkers in the Hematolymphoid Screening Panel
CD2

CD3

CD4

CD5

CD7

CD8

CD10

CD11b

CD13

CD14

CD15

CD16

CD19

CD20

CD23

CD33

CD34

CD38

CD45

CD56

CD57

CD64

CD71

CD117

CD123

HLA-DRKappaLambda

TCR Gamma/DeltaAbnormal B-cells co-expressing T-cell antigen CD5 with CD19.

AML MRD Assay

Use of a LAIP-based DfN approach and an extensive selectionof antibodies, including a standardized 12-color panel, enables
immunophenotypic profiling with unparalleled specificity.
Characterize and monitor MRD populations to 0.01%
Predict treatment outcomes and use as a potential
primary end point in clinical trials

CLL MRD Assay

An extensive 11-color panel targeting 12 specific biomarkers,
depicts clear separation of CLL cells from other B-lineage
cells.12-14 Designed to work with peripheral blood and bonemarrow specimens.
Characterize aberrant cell population by MFC
Detect and track residual disease to 0.005%
Assess therapeutic response and use as a surrogate
endpoint to accelerate approvals
Biomarkers in the CLL MRD Assay
CD3

CD5

CD19

CD20

CD22

CD40

CD13

CD43

CD79b

CD81

CD16

CD200

7AAD

CD38

Biomarkers in the AML MRD Assay
CD2

CD4

CD7

CD11b

CD14

CD15

CD5

CD19

CD33

CD34

CD36

CD38

CD45

CD56

CD64

CD117

CD123

HLA-DR

7AAD

AML MRD population (LAIP) is gated by choosing combinations that makeaberrant populations identifiable and trackable based on DfN.

Identification of a CLL MRD population in a scatter plot indicating CD5 andCD200 antigen expression.

References
1. Batista, JL et al. (2017). Pathology and Epidemiology of Cancer. Springer, Cham.
https://doi.org/10.1007/978-3-319-35153-7_29
2. Keykhaei, M et al. Exp Hematol Oncol 10, 11 (2021). https://doi.org/10.1186/s40164-021-00198-2
3. Hematologic Cancer Incidence, Survival, and Prevalence. USCS Data Brief, no. 30.
Atlanta, GA: Centers for Disease Control and Prevention, US Department of Healthand Human Services; 2022. https://www.cdc.gov/cancer/uscs/pdf/USCS-Data
Brief-No30-September2022-h.pdf

4. Y Dong et al. Exp Hematol Oncol 9, 14 (2020). https://doi.org/10.1186/s40164-020-00170-6
5. ES Winer et al. Ther Adv Hematol. 2019;10: 2040620719860645.
6. QS Wang et al. Mol Ther. 2015;23:184–91.
7. N Daver et al. Cancer Discov. 2019;9:370–83.8. GL Schuurhuis et al. Blood 131(12):1275 1291 (2018)
9. BL Wood et al. Cytometry B: Clin. Cytom. 72(S1), S14 S22 (2007)

10. SH Swerdlow et al., WHO Classiﬁcation of Tumors, (Revised 4th Edition) IARC: Lyon, 421 (2017)
11. Y Ou et al. Frontiers in Oncology https://doi.org/10.3389/fonc.2022.840616
12. WG Wierda et al. Leukemia. 2021; 35:3059–3072. https://doi.org/10.1038/s41375-021-01241-1
13. AC Rawstron et al. Leukemia. 2016; Apr;30(4):929-36. doi: 10.1038/leu.2015.313. Epub 2015
Dec 7.
14. AC Rawstron et al. Leukemia. 2013 Jan;27(1):142-9. doi: 10.1038/leu.2012.216. Epub 2012 Jul 31.

M-0109 Rev 02 May 2023