Companion Diagnostic (CDx) Services by Medivdpharma (MIP)
Medivdpharma (MIP) offers end-to-end Companion Diagnostic (CDx) services to support the co-development and commercialization of diagnostic tests paired with specific therapeutic drugs. Our expertise ensures that these tests accurately identify patients who are most likely to benefit from a treatment or be at risk for serious side effects, enabling personalized and precision medicine.
How Companion Diagnostics Advance Drug Development
CDx services play a critical role in modern drug development by:
Enriching Clinical
Trials
Identifying and recruiting patients with specific biomarkers or genetic mutations. Increasing trial efficiency, success rates, and reducing participant numbers.
Accelerating Regulatory Approval
Facilitating co-development of drugs and diagnostics for concurrent FDA/EMA approval. Streamlining regulatory reviews for targeted therapies.
Reducing Costs and Risks
Ensuring drugs are administered only to likely responders. Avoiding ineffective treatments and minimizing adverse reactions.
Expanding Market Access
Enabling drug use in specific patient populations. Securing reimbursement from payers through validated CDx tests.
Our CDx Service Portfolio
See our solutions in action with a personalized demo and discover how they can drive results for your business.
Biomarker Discovery and Validation
- Biomarker Identification: Using advanced technologies (NGS, PCR, immunohistochemistry) to pinpoint biomarkers predictive of treatment response.
- Assay Development: Designing and optimizing reliable assays to detect target biomarkers.
- Analytical Validation: Confirming assay accuracy, precision, and reproducibility.
Clinical and Regulatory Support
- Clinical Trial Management: Handling diagnostic aspects of trials, including patient screening and response monitoring.
- Regulatory Strategy: Navigating complex FDA (e.g., PMA, 510(k)) and EU (IVDR) pathways for concurrent drug-diagnostic approval.
- Submission Documentation: Preparing and reviewing regulatory dossiers for simultaneous submissions.
Commercialization and Post-Market Services
- Manufacturing and Quality Assurance: Ensuring consistent, scalable production of validated CDx tests.
- Global Logistics: Managing sample routing to testing labs for rapid results.
- Post-Market Surveillance: Monitoring real-world test performance and compliance with regulatory requirements.
Why Partner with MIP for CDx Services?
01.
End-to-End Expertise
From biomarker discovery to post-market surveillance.
02.
Regulatory Excellence
Deep experience with FDA, EMA, and IVDR requirements.
03.
Precision Medicine Focus
Enabling targeted therapies through robust diagnostics.
04.
Global Reach
Supporting clinical trials and commercialization across regions.