* This field is required

Companion Diagnostics Development Service

  • Home
  • Companion Diagnostics Development Service
Solutions
Online Inquiry

Companion Diagnostics Development Service

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.

What is a Companion Diagnostic?

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.

Companion diagnostics play a crucial role in personalized therapy.Fig. 1 Companion diagnostics help promote personalized therapies. (Kang, Su Lim, et al., 2023)

Importance of Companion Diagnostics in Rare Disease Diagnosis

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.

Our Services

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.

Workflow of Companion Diagnostics Development

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.

Our Assays for Companion Diagnostics Development

  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Flow Cytometry
  • Immunohistochemistry (IHC)
  • Next-Generation Sequencing (NGS)
  • Polymerase Chain Reaction (PCR)
  • Fluorescence In Situ Hybridization (FISH)
  • Multiplex Immunofluorescence (mIF)
  • And More

Our Advantages

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

  1. Kang, Su Lim, et al. "Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS." Molecular Therapy-Methods & Clinical Development 30 (2023): 447-458.
  2. Mankoff, David A., et al. "Development of companion diagnostics." Seminars in nuclear medicine. Vol. 46. No. 1. WB Saunders, 2016.

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