Companion Diagnostics

Biopharma / Research Services

Companion Diagnostics

What is Companion Diagnostics

A companion diagnostics is a specialised test designed to match patients with the most suitable drug or therapy. By identifying specific genetic changes, biomarkers or other biomedical factors these tests help determine whether a patient is likely to respond to a particular treatment. This ensures safer, more effective therapies while personalising medical care.
Companion diagnostics role in precision medicine
  • Identifies patients most likely to benefit from a particular therapeutic product.
  • Screens patients likely to be at risk for side effects from a particular therapeutic product.
  • Monitors patient’s response to treatment from a particular therapeutic product.

Benefits of Companion Diagnostics

Beyond improving patient outcomes, companion diagnostics offer significant advantages in drug development and precision medicine:
Enhancing treatment selection

These tests help physicians identify the right treatment for the right patient, reducing unnecessary treatments and potential side effects.

Reducing drug development costs

By selecting the most responsive patients for clinical trials. Pharmaceutical companies can conduct smaller, faster trials, lowering costs and accelerating drug approval.

Increasing drug approval rates

Personalised treatment approaches improve the safety and efficacy of drugs. Streamlining regulatory approvals and bringing medications to market more efficiently.

How Can We Support You

The sooner you begin evaluating a CDx and prepare the CDx for market, the easier the journey becomes. Genseq can support you on all steps of this journey.
  • Support biomarker identification
  • Support with IVDR compliance documentation and compliance
  • Clinical validation of assay
  • Assay accreditation to ISO15189:2022, CLIA and CAP standard, accredited service provider ready for launch.


From development to commercialisation, Genseq provides a data driven approach to CDx partnerships

With extensive in-house expertise, Genseq’s approach to CDx development and approval is strategically designed to save time, reduce complexity and improve the probability of success. Genseq offers a wide range of NGS tests to support pharma, including DNA and RNA tissue-based assays.

What We Offer

  • Parallel development of drugs and diagnostics – the path to successfully co-develop a CDx and the corresponding drug is complex.
  • Establishing successful prelaunch partnerships with Biopharma companies to ensure drug candidates are commercially ready and patient access is optimised.
  • Maximum uptake of your co-developed drug and Dx.
  • Deploying a drug-Dx co-development strategy as part of your therapeutic endeavour.

The Drug Discovery Journey

Drug Development Phases

How can we support you

Discovery
Biomarker Selection
Pre-clinical
Biomarker Feasibility
Phase 1
Compliance Support
(CE-IVD/IVDR)
Phase 2
Validation
Phase 3
Clinical Validation
Approval
Approval
Accredited Service Provider
Approved CDx
Approval
Accredited Service Provider
Approved CDx
1
2
3

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