IVD Kit Development
Swift and accurate diagnosis aids in timely intervention for rare movement and neurological disorders. With advanced technological platforms and abundant professional knowledge, Protheragen focuses on developing cutting-edge in vitro diagnostic (IVD) kits. These kits are convenient and efficient, helping to simplify diagnostic procedures and improve diagnostic efficiency.
Significance of IVD Kit Development
The characteristics of rare movement and neurological disorders are complexity and heterogeneity, posing unique challenges in accurate and timely diagnosis. In vitro diagnostic (IVD) kits detect disease biomarkers at the molecular level, aiding in the rapid and precise diagnosis of diseases, thereby facilitating timely intervention and personalized therapeutic strategies. Therefore, the development of IVD kits could help revolutionize diagnostic practice and facilitate the effective management of rare movement and neurological disorders.
Fig. 1 Typical NGS variant detection data analysis steps. (Pant S, et al., 2014)
IVD Kits for Rare Movement and Neurological Disorders
In recent years, there have been significant advancements in the in vitro diagnostics (IVD) field for rare movement and neurological disorders, owing to rapid technological innovations and an increasingly deeper understanding of the molecular basis of these diseases. The integration of high-throughput sequencing technologies such as next-generation sequencing (NGS) has made comprehensive genetic analysis of these disorders possible. The discovery of biomarkers holds immense potential for enhancing diagnostic accuracy, monitoring disease progression, and predicting therapeutic responses.
Table. 1 Common IVD kits for rare movement and neurological disorders.
| Kits | Applications | Detection Methods |
| SMN1 Gene Detection Kit | This kit is used to determine the SMN1 gene copy number for the diagnosis of spinal muscular atrophy (SMA). | Real-time PCR |
| Creatine Kinase Activity Assay Kit | This kit is used to measure the level of creatine kinase in the blood. | Colorimetric or Enzymatic Assays |
| Duchenne Muscular Dystrophy (DMD) Gene Sequencing Kit | The kit diagnoses Duchenne muscular dystrophy by performing whole genome sequencing of samples. | Next Generation Sequencing (NGS) |
| Neurofilament Light Chain (NfL) ELISA Kit | The kit measures levels of neurofilament light chain (NfL) in cerebrospinal fluid or blood to indicate the extent of neuronal damage. | ELISA |
| Tau Protein Kit | Tau protein is associated with neurodegenerative diseases. This kit is used to measure tau protein levels in cerebrospinal fluid or blood samples. | ELISA |
| Amyloid β ELISA Kit | The kit could aid in early diagnosis and monitoring of the progression of Alzheimer's disease. | ELISA |
Our Services
At Protheragen, we are dedicated to advancing the field of in vitro diagnostics (IVD) for rare movement and neurological disorders. Our scientists conduct in-depth research on the diagnostic biomarkers of these diseases and integrate advanced technologies to develop precise and reliable IVD kits. These kits streamline diagnostic procedures, facilitating effective disease management.
Workflow for IVD Kit Development
Optimal Assay Formats
| Immunoassays | Molecular Diagnostics |
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| Protein Assays | Point-of-Care Testing (POCT) |
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Our assay formats are not limited to the above. With advanced technology platforms, we are committed to providing customized IVD solutions for complex diseases such as rare motor neuron diseases, rare musculoskeletal diseases, rare neurological diseases, etc. If you are interested in our services, please feel free to contact us for more details and quotation information of related services.
Reference
- Pant S, Weiner R, Marton M J. Navigating the rapids: the development of regulated next-generation sequencing-based clinical trial assays and companion diagnostics[J]. Frontiers in oncology, 2014, 4: 78.