Pernicious anemia is an autoimmune disorder with a complex origin characterized by chronic atrophic gastritis (CAG) and impaired vitamin B₁₂ (cobalamin) absorption in the terminal ileum due to intrinsic factor (IF) antibody interference. Our company is dedicated to delivering all-encompassing diagnostic development services, encompassing cutting-edge IVD products, point-of-care testing, and companion diagnostic development services, tailored to address the distinctive challenges posed by rare diseases.

Overview of Pernicious Anemia

The multifaceted nature of pernicious anemia is closely tied to the crucial role of cobalamin, deficiencies of which can result in various dysfunctions spanning from hematopoiesis to neurological, psychiatric, and obstetric anomalies. The primary manifestations of pernicious anemia manifest as hematological and neurological complications stemming from vitamin B₁₂ deficiency, both of which necessitate several years to develop fully.

Although the exact pathogenesis of pernicious anemia remains unclear, it is likely associated with the autoimmune destruction of gastric glands triggered by autoreactive T lymphocytes in genetically predisposed individuals.

Fig.1 Peripheral smear of individuals with pernicious anemia. (Thomes, R. M., and Rosenstein, L. J., 2020)

Biomarkers Development for Pernicious Anemia

The ongoing progress in biomarker development for pernicious anemia shows potential for improving early detection, tailoring therapy strategies, and tracking disease progression in individuals. Below are some critical biomarkers associated with pernicious anemia:

Serum Cobalamin Assay

Measuring serum vitamin B₁₂ levels is a critical diagnostic procedure for pernicious anemia. Serum vitamin B₁₂ levels exceeding 300 pg/mL are considered within the normal range.

Homocysteine and Methylmalonic Acid

Elevated homocysteine and methylmalonic acid levels in the bloodstream can indicate a deficiency in vitamin B₁₂ and are utilized as supplementary markers for pernicious anemia.

Serum Holotranscolabamin (HTC) Assay

HTC, a form of vitamin B₁₂ bound to transcobalamin, serves as the sole active form for cellular metabolism. HTC has been proposed as an ideal indicator of early-stage vitamin B₁₂ deficiency.

Parietal Cell Antibodies and IF Antibodies

Assessing anti-parietal cell antibodies that target the gastric proton pump (gastric H⁺/K⁺ ATPase) along with antibodies against IF proves beneficial in confirming a diagnosis of pernicious anemia.

IVD Kits for Pernicious Anemia

Our Services

Leveraging cutting-edge technologies and a diverse team of specialists, we provide accurate and effective solutions for the development of IVD products to assist in identifying and comprehending pernicious anemia. Furthermore, we offer point-of-care testing and companion diagnostic development services to enhance the precision and promptness of diagnoses.

IVD Reagent/Kit Development

• Proof of Concept and Feasibility
• IVD Reagent/Kit Design Service
• IVD Reagent/Kit Verification
• IVD Reagent/Kit Optimization

IVD Device Development

• Preparation of Device Development Plan
• Prototype Design Service
• Styling Machine Development Service
• Device Verification and Optimization

Our customized diagnostic development services not only improve diagnostic precision but also aid researchers and scientists in expanding their comprehension of rare diseases, leading to personalized therapy approaches and enhanced individual results. If you are interested in our services, feel free to reach out to us for more information.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.