IVD Antibody & Immunoassay Development Services for Leukemia Biomarkers

Creative Biolabs has extensive experience in the in vitro diagnostic (IVD) antibody as well as diagnostic test/assay development targeting a wide range of biomarkers of different diseases. Especially, here we introduce the biomarkers and antibody/immunoassay development services for leukemia biomarkers.

Introduction to Leukemia

Normal blood versus leukemia blood cells. (Shawly and A. Alsheikhy, 2022)Fig.1 Normal blood versus leukemia blood cells.1

Leukemia is a group of cancers that present with increased numbers of leucocytes in the blood and/or the bone marrow. There are four main types of leukemia: acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), and chronic myeloid leukemia (CML). The dominantly presenting leukemia cells may be mature such as in CLL, or precursor cells of various lineages such as in the ALL and AML, or both precursor and mature cells as in CML. Moreover, leukemias may present at all ages but different forms have very different age distributions, with the ALL most common in children, whereas AML and CLL being most common in adults.

The exact cause of leukemia is not clear and different kinds of leukemia usually have different causes, including both inherited and environmental factors. Treatment of leukemias may involve some combination of chemotherapy, radiation therapy, targeted therapy, and bone marrow transplant. However, the success of treatment depends on the type of leukemia and the age of the person. Thus, to assure the best patient care possible, a multiparametric approach to diagnosis is required to avoid missed or improper diagnosis.

Diagnostic Tools of Leukemia

Leukemia is typically diagnosed via abnormal results on a full blood count followed by an examination of a blood film. The diagnosis is usually confirmed on a bone marrow aspirate and/or trephine biopsy looking at cell morphology and bone marrow architecture. Additional techniques that may be used to further classify the type of leukemia include flow cytometric immunophenotyping and genetic studies. Genetic studies are crucially important for the diagnosis of leukemia, especially with regards to prognosis and therapeutic choice. Commonly used genetic techniques at diagnosis of leukemia include G-ban metaphase cytogenetics, fluorescence in situ hybridization (FISH), and in vitro molecular techniques (e.g. comparative genomic hybridization, SNP arrays, and PCR-based techniques).

The pathologic immune microenvironment of acute myeloid leukemia. (Vago, et al., 2022)Fig.2 The pathologic immune microenvironment of acute myeloid leukemia.2

Flow Cytometry Immunophenotyping

Flow cytometric immunophenotyping is an indispensable tool for the diagnosis, classification, staging, and monitoring of hematologic neoplasms such as leukemias. Moreover, in the last 10 years, great advances in flow cytometry instrumentation and availability of an expanded range of antibodies and fluorochromes have improved our ability to identify different normal cell populations and recognize phenotypic aberrancies. Although this technique is much younger than morphology, it has gained an undisputed place in the diagnostic workup of leukemias.

IVD Antibody & Immunoassay Development Services Provided by Creative Biolabs

Creative Biolabs provides in-depth expertise in both IVD and immunoassay development services. Based on our years of experience, we offer flexible support in different phases of the IVD project, including assay design, raw material selection, working protocol establishment, assay validation, and kit manufacturing. Creative Biolabs offers comprehensive contract development services including:

Workflow-for-production-of-an-Immunoassay. (Creative Biolabs Original)

Our services can be tailored targeting different biomarkers with potential for leukemia diagnosis and prognosis, including but not limited to:

Features of Our Services

  • Expertise in a broad range of disease biomarkers and pathogens
  • Fully flexible phase-gated product development services
  • Customized packages to meet specific requirements in terms of budget, assay application, and timescale
  • Cutting edge technologies, keen project and program management skills

Please feel free to contact us for more information and discuss your project needs.

References

  1. Shawly, A. Alsheikhy, "Biomedical Diagnosis of Leukemia Using a Deep Learner Classifier", Computational Intelligence and Neuroscience (2022): Article ID 1568375, 9 pages, https://doi.org/10.1155/2022/1568375
  2. Vago, Luca, and Ivana Gojo. "Immune escape and immunotherapy of acute myeloid leukemia." The Journal of clinical investigation 130.4 (2020): 1552-1564.

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