Companion Diagnostics Development Service
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Our company specializes in providing end-to-end services for the development of comprehensive companion diagnostics. With our expertise, we contribute to the revolutionary advancements in rare disease diagnostics and facilitate the implementation of personalized therapeutic strategies.
A companion diagnostic is a medical device or test that is a powerful tool to help identify and characterize rare diseases. It serves as an effective means of determining specific biomarkers or genetic variations associated with a disease. A companion diagnostic is designed to be used alongside particular therapeutic products or therapies, enabling precise diagnosis and personalized therapeutic strategies.
Fig. 1 Companion diagnostics help promote personalized therapies. (Kang, Su Lim, et al., 2023)
Early Detection and Diagnosis
Companion diagnostics can detect genetic mutations or biomarkers associated with rare diseases even before clinical symptoms manifest. This allows for early diagnosis, enabling prompt therapeutic initiation and potentially better intervention outcomes.
Promoting Personalized Therapy
Companion diagnostics aid in personalized therapies by matching suitable therapeutic options to the appropriate patients based on analysis of specific biomarkers or genetic mutations. This facilitates optimal therapeutic outcomes and minimizes unnecessary interventions.
Monitoring Therapeutic Response
With companion diagnostics, medical professionals can evaluate the effectiveness of therapeutics over time. This information helps in evaluating therapeutic efficacy, making timely adjustments, and optimizing therapeutic strategies.
The development of companion diagnostics carries specific challenges - from assay development and validation, to determining the ideal regulatory pathway, to coordinating companion diagnostics timelines with its therapeutic to align parallel approvals. At our company, we integrate assay development, analytical validation, regulatory strategy and therapeutic development to execute efficient companion diagnostic development programs for rare diseases.
Biomarker Identification
The initial phase involves identifying potential biomarkers associated with the rare disease. Our scientists use genomic sequencing, transcriptomic analysis, or proteomic profiling to identify genetic mutations or specific biomolecules indicative of the disease.
Analytical Validation
The developed assay undergoes analytical validation to assess its performance characteristics. This includes evaluating its sensitivity, specificity, precision, etc. The validation process ensures that the assay reliably and consistently measures the target biomarker.
Concurrent Therapeutic Development
Companion diagnostics are developed in parallel with therapeutic agents or interventions targeting the rare disease. Close coordination between diagnostic and therapeutic development teams ensures the timely alignment of companion diagnostic and therapeutic approvals.
Assay Development
Next, we develop assays capable of detecting and measuring these biomarkers accurately. This process may include the design of PCR-based assays, immunohistochemistry techniques, or next-generation sequencing platforms.
Regulatory Submission
Once the assay has undergone successful analytical, the data generated from these studies are compiled for regulatory submission. The submission typically includes detailed documentation on the assay's design, performance characteristics, etc.
Time-saving services with high efficiency
Professional and experienced team
Cutting edge technology platform
Numerous service cases and customer praise
Our company remains at the forefront of innovation, dedicating to improving diagnostic capabilities for rare diseases. If you are interested in our services, please don't hesitate to contact us for further information and pricing details.
References
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.