Systemic sclerosis, also known as scleroderma, stands as a rare and intricate autoimmune connective tissue disorder. Positioned as a frontrunner in rare disease diagnostic advancements, we provide a spectrum of diagnostic solutions customized for systemic sclerosis. These encompass IVD products, point-of-care testing, and companion diagnostic development services, catering to the varied diagnostic requirements of systemic sclerosis.
Overview of Systemic Sclerosis
Systemic sclerosis represents an autoimmune-triggered chronic fibrosing ailment, characterized by autoimmunity, skin and internal organ fibrosis, and vasculopathy. The annual incidence of systemic sclerosis is estimated to range between 7.2 and 33.9 per 100,000 individuals, respectively.
Its pathophysiology is intricate, involving early endothelial damage, inflammatory infiltration, and subsequent fibrotic responses. Rooted in a genetic predisposition, an imbalanced interplay of acquired and innate immune systems triggers the secretion of numerous cytokines, chemokines, and autoantibodies, culminating in fibroblast activation, myofibroblast formation, and the deposition of rigid connective tissue.
Fig.1 The pathogenesis of systemic sclerosis. (Rosendahl, A. H., et al., 2022)
Biomarkers Development for Systemic Sclerosis
Research has pinpointed a range of biomarkers related to systemic sclerosis, which have not only enhanced diagnostic precision but also offered valuable insights into disease subtypes and prognostic outcomes.
Autoantibodies
Various autoantibodies are tied to different systemic sclerosis subtypes, each associated with distinct manifestations and prognoses. Detecting these autoantibodies assists in pinpointing specific systemic sclerosis subsets and predicting disease progression.
- Anti-centromere
- Anti-topoisomerase 1 (anti-Scl 70)
- Anti-RNA polymerase 3
- Anti-U1 ribonucleoprotein
- Anti-U3 ribonucleoprotein (anti-fibrillarin)
- Anti-Pm-Scl
- Anti-Th/To
Other Biomarkers
Unusual levels of cytokines and chemokines have been detected in individuals with systemic sclerosis, reflecting the underlying inflammatory and fibrotic processes. The abnormal levels of these biomarkers have been linked to the pathogenesis of systemic sclerosis.
- C-reactive protein (CRP)
- Transforming growth factor-beta (TGF-β)
- Interleukin 6 (IL-6)
- Interferon-1 signaling
- Krebs von den Lungen glycoprotein-6
- Chemokine ligand 2 (CCL2)
- Chemokine ligand 18 (CCL18)
IVD Kits for Systemic Sclerosis
| Kits |
Applications |
Method of detection |
| CRP Detection Kit |
Measurement of CRP in plasma, cell culture supernatant, and serum samples |
ELISA, latex agglutination test, slide agglutination assay |
| Anti-Scl-70 ELISA Kit |
Detection of autoantibodies specific for Scl-70 antigen |
ELISA |
| Anti-centromere Antibodies Detection Kit |
Detect the presence of anti-centromere antibodies |
ELISA, IFA |
| Anti-RNA Polymerase 3 Antibodies ELISA kit |
Assessing anti-RNA polymerase 3 antibody levels in serum, plasma, urine, tissue homogenates, and cell culture supernatants |
ELISA |
Our Services
Our company specializes in rare disease diagnostic development, such as systemic sclerosis, channeling our expertise, resources, and advanced technology toward developing IVD products. Alongside this, we offer point-of-care testing and companion diagnostic development services tailored to swiftly and precisely diagnose systemic sclerosis.
With a strong focus on biomarker discovery for systemic sclerosis, we are committed to progressing diagnostic and therapeutic development, supporting your research in early detection, prognosis, and therapy monitoring for systemic sclerosis, ultimately improving individual outcomes. For inquiries about our services, please do not hesitate to contact us for further details and pricing information.
References
- Volkmann, Elizabeth R et al. "Systemic sclerosis." Lancet (London, England) 401.10373 (2023): 304-318.
- Rosendahl, Ann-Helen et al. "Pathophysiology of systemic sclerosis (scleroderma)." The Kaohsiung journal of medical sciences 38.3 (2022): 187-195.
All of our services and products are intended for preclinical research use
only and cannot be used to diagnose, treat or manage patients.
