Companion Diagnostic Development Services for Clinical Trials
From first-in-human biomarker strategy through pivotal trial testing and regulatory submission, Discovery Life Sciences provides a full range of prototype companion diagnostic development services across IHC, ISH, PCR, and NGS platforms. With wholly-owned laboratories in the US and Germany, IVDR Health Institution designation, and a regulatory track record spanning FDA, EU/IVDR, and UK/MHRA, we are the CDx partner built to move your drug-diagnostic co-development forward without compromise.
Drug-diagnostic co-development without compromise.
From first-in-human biomarker strategy through pivotal trial testing and regulatory submission, Discovery Life Sciences provides end-to-end Clinical Trial Assay development services across IHC, ISH, PCR, and NGS platforms. With wholly-owned laboratories in the US and Germany, IVDR Health Institution designation, and a regulatory track record spanning FDA, EU/IVDR, and UK/MHRA, we are the CDx partner built to move your drug-diagnostic co-development forward without compromise.
Custom Clinical Trial Assay Development Projects Since 2020
EU IVDR Projects Under Health Institution Status
CTAs Receive FDA Non-Significant Risk Determination
Clinical Studies With Prospective Central Testing
Building Clinical Trial Assays with Commercialization in Mind
The choices made at the assay development stage determine the speed, cost, and regulatory risk of the entire drug-diagnostic co-development program. Discovery scientists build prototype companion diagnostic assays (also called Clinical Trial Assays) from the outset on platforms and with reagents that have an established pathway from lab developed test (LDT) to commercial CDx. That means fewer pivots, lower downstream costs, and a smoother transition into pivotal and commercialization phases.
Our LDT-First Development Model
An LDT approach gives development teams maximum flexibility during early clinical development before the need for a CDx is confirmed and commitment to a locked, market-ready CDx kit is warranted. Under this model:
- Platforms and reagents are selected with documented freedom-to-operate and a durable supply chain
- Standardized pre-analytical workflows are established from day one
- Fit-for-purpose RUO validation sets analytical thresholds and preliminary clinical utility
- CLIA-grade LDT validation supports patient management and enrollment decisions
- Manufacturing partners are engaged early to identify and deploy pre-optimized solutions
Why an LDT Model Accelerates CDx Programs
Speed
- RUO assays are typically ready within 4-5 months. CLIA-grade LDTs are deployment-ready in 6 to 8 months, compared to significantly longer timelines for locked, kitted commercial assays.
Flexibility
- The assay can evolve as clinical trial data emerge, with modifications that would be far more disruptive and costly in a locked commercial CDx format.
Cost Efficiency
- Development cost is lower relative to a fully locked and kitted assay, allowing programs to conserve budget until clinical data confirm the CDx requirement.
De-risked Commercialization
- Development teams avoid committing to a manufactured CDx kit before the drug-biomarker relationship and patient selection strategy are confirmed.
Clinical Trial Assay Development: Scalable from FIH to Pivotal
Regulators expect companion diagnostics and their partner therapeutics to be developed contemporaneously. Upfront planning is essential: assays built for preclinical or first-in-human studies must be scalable to support patient enrollment, pivotal studies, and simultaneous drug-diagnostic approval.
Programs that optimize assay architecture (with an eye towards commercialization) before first-in-human consistently move faster through pivotal validation. Re-validation costs drop, and regulatory questions arrive earlier when they are cheaper to answer.
Discovery’s clinical trial assay development approach includes:
- Rigorous analytical validation to Clinical Laboratory Standards Institute (CLSI) and CLIA/CAP standards for Clinical Trial Assays
- Comprehensive documentation packages to support client quality audits and regulatory submissions
- Expanded multi-reagent and multi-platform screening to identify the optimized solution before pivotal commitment
- Global deployment of harmonized assays to Discovery’s wholly-owned US and EU laboratories and China CRO network
- Assistance with regulatory compliance strategy and agency filing preparation
Global Clinical Trial Testing: From Development Lab to Patient Sample
A companion diagnostic only delivers value when patient samples are tested accurately, on time, and at global scale. Discovery provides seamless deployment of lab developed tests and investigational use only kits from our wholly-owned US and EU laboratories, with access to China CRO partners for APAC coverage.
Turnaround Times
Fast response time without sacrificing quality and accuracy
- IHC: 3 to 5 business days
- PCR: 3 to 7 business days
- Targeted NGS: 7 to 10 business days
Partner Compatibility
Global lab network ensures seamless collaboration
- Established working relationships with all major contract research organizations
- Experience collaborating with all major in vitro diagnostic (IVD) manufacturers
Data Management and Reporting
Streamline clinical studies with real‑time, customized reporting, ensuring regulatory‑compliant data
- Real-time and customized result reporting to clinical sites
- Formal data compilation and management to support regulatory submissions
- Ongoing laboratory proficiency testing and quality oversight
- Study monitoring and regulatory audit support
- Global kit management and logistics services
Companion Diagnostic Tests Ready for Rapid Deployment
Discovery maintains a validated menu of established companion diagnostic tests that can be deployed quickly to support clinical trials. We regularly re-validate established CDx assays for new tissue types, clinical applications, and cutoff thresholds to meet evolving trial requirements.
If you don’t see it on our menu, please reach out directly as custom assay development is one of our core capabilities.
| ALK IHC / FISH | ROS1 FISH | cMET IHC |
| PD-L1 (clones 22C3, SP263, 28-8) | HER2 (IHC, FISH, and dual ISH) | Cobas EGFR v2 |
| Cobas KRAS | Biocartis Idylla® | Mismatch Repair IHC (MLH1, MSH2, MSH6, PMS2) |
| Promega OncoMate MSI Dx | AmoyDx BRCA1/2 | SeCore HLA-A |
| FOLR1 IHC | EntroGen KRAS/NRAS |
Regulatory Support Across FDA, EU/IVDR, and UK/MHRA
Regulatory requirements for CDx differ sharply by jurisdiction, and each one drives timeline decisions you make months before submission. Discovery’s Quality Management System and Regulatory Affairs team have direct experience navigating device regulations across the US, EU, and UK.
FDA IDE Compliance
Novel assays used for medical purposes in a clinical trial require compliance with FDA Investigational New Device (IDE) regulations. Discovery provides support across the full IDE process:
- Study risk determination strategy and documentation
- IDE filing preparation and submission support
- Agency communications and response drafting
IVDR Health Institution Advantage
Under EU IVDR, any device used for medical purposes in a clinical trial must be CE-IVD approved or, if no approved device exists, deployed either through a Health Institution exemption or under a Performance Study Application (PSA).
Discovery’s laboratory in Kassel, Germany holds Health Institution designation, which provides a significant regulatory and timeline advantage: novel assays can be deployed as LDTs without the need for a PSA.
MHRA Technical Submission
Since 2025, biomarker assays used for medical purposes in UK clinical trials require a dedicated technical submission to the MHRA as part of the clinical trial application. Depending on the assay’s validation status, this may include a Study Checklist, Tabular Summary, or both.
Discovery has direct experience preparing MHRA technical documentation and responding to Agency inquiries across multiple studies since the current regulations came into effect. We can support preparation of submission-ready documentation and manage MHRA correspondence throughout the study.
>95% of clinical trial assays developed by Discovery and submitted for FDA review are determined to be non-significant risk, reducing IDE burden and accelerating study timelines.
DISCOVERY – HEALTH INSTITUTION LDT
6-8 Months
From project start to first patient sample. No Performance Study Application required.
PERFORMANCE STUDY APPLICATION ROUTE
8-12 Months
Typically adds 6 or more months on top of standard development timelines.
Discovery’s IVDR track record since May 2022:
- More than 40 projects initiated across IHC, ISH, NGS, PCR, RT-PCR, and Sanger sequencing
- Coverage across 23 EU member states plus Switzerland and the UK
- 22 unique biomarkers developed and deployed
- Both novel biomarkers and re-purposed or re-validated CE-IVD assays
- All LDTs analytically validated to CLSI standards under full Design History File controls
Supported Platforms for Clinical Trial Assay Development
| IHC / ISH | PCR | NGS/Sequencing | Immunoassay |
|---|---|---|---|
| Leica Bond III | Thermo Fisher Quantstudio 7 | Ilumina MiSeq | Manual ELISA |
| Leica Bond Rx | Biocartis Idylla | Illumina MiSeq i100 | |
| Dako Omnis | Roche Cobas 5800 | Illumina NextSeq 550 | |
| Dako Link 48 Autostainer | Roche Cobas z80 | Thermo Fisher Genetic Analyzer | |
| Ventana Benchmark Ultra | Qaigen Rotor-Gene Q MDx | | |
| Ventana Benchmark Ultra Plus | | | |
| Ventana Discovery | | | |
CDx Strategy Consultation: From Biomarker Discovery to Commercialization
Most drug teams hit the same three or four CDx decisions for the first time on their first program. Platform, manufacturing partner, regulatory pathway, and LDT versus commercial commitment all set the budget and timeline for everything that follows.
As of 2025, Discovery initiates approximately 15 to 20 new prototype CDx studies per year. Our scientists, regulatory affairs experts, and commercial leads are available to help development teams navigate the full arc from biomarker discovery to CDx commercialization.
Key strategic questions we help development teams address:
- When do regulators expect a CDx development program to begin, and what does ‘contemporaneous development’ require in practice?
- Which platform and technology choices today will limit or enable a commercial CDx pathway tomorrow?
- What are the regulatory implications of an LDT-first strategy vs. a commercial CDx from the outset?
- How do EU IVDR Health Institution pathways affect study timelines and budget compared to a Performance Study Application?
- What manufacturing partnerships should be initiated before Phase II?
- How to quickly develop a Clinical Trial Assay to support accelerated oncology development and approval?
