Accelerating Your Companion Diagnostics Path To Regulatory Approval
Companion diagnostics (CDx) represent one of the most technically and regulatorily complex pathways in the diagnostic industry. The coordination required between drug development programs, diagnostic validation, and parallel regulatory submissions creates challenges that few companion diagnostics CDMOs are equipped to navigate successfully.
Abingdon Health specialises in moving companion diagnostic projects from initial biomarker concepts through FDA approval and commercial manufacturing. Our integrated approach as an in vitro diagnostics development partner addresses the unique complexities of CDx development, where technical performance, regulatory strategy, and manufacturing scalability must advance in parallel from day one.
Why Companion Diagnostics Demand a Different Approach
Unlike standalone diagnostics, companion diagnostic development operates under fundamentally different constraints. Your timeline is determined by your drug development program. Your regulatory submission must demonstrate not just analytical validity but clinical validity within the context of specific therapeutic decisions. Your manufacturing processes must scale to match drug launch volumes with zero tolerance for supply interruptions.
These constraints mean that technical decisions made during early development have cascading implications for regulatory approval timelines and commercial manufacturing feasibility. Choosing antibodies that perform brilliantly in research-grade assays but cannot be manufactured consistently at scale creates problems that emerge months or years later. Designing test formats that work perfectly in controlled laboratory settings but fail reliability requirements in real-world clinical use leads to expensive redesigns during validation.
We’ve built our companion diagnostics development capabilities around this reality. Our development team includes scientists with direct experience in CDx programs who understand that “good enough for research” is fundamentally different from “acceptable for FDA submission.”
Integrated Development Expertise:
Our regulatory specialists have navigated the specific requirements of Pre-Market Approval (PMA) submissions for companion diagnostics, including the coordination required with parallel drug application reviews.
Biomarker Assessment & Feasibility
Early-stage evaluation of whether your biomarker concept can be translated into a manufacturable lateral flow format. We assess antibody availability, sample matrix compatibility, required sensitivity and specificity parameters, and manufacturing scalability before significant investment occurs.
Assay Development & Optimization
Design for manufacturing is embedded from initial development. We optimise assay architectures that deliver required clinical performance while maintaining manufacturing robustness. Our lateral flow assay development services include rigorous design review checkpoints that catch potential manufacturing or regulatory issues before they become expensive problems.
Clinical Trial Support
Companion diagnostics require successful performance in clinical trial settings under real-world conditions. We provide clinical-grade test manufacturing, lot-to-lot consistency documentation, stability data for trial durations, and technical support for clinical sites. Our quality systems generate the documentation FDA expects to see in your PMA submission.
Analytical & Clinical Validation
Comprehensive validation studies designed to meet FDA’s expectations for analytical validity (precision, accuracy, sensitivity, specificity, interfering substances) and clinical validity (performance in intended-use populations). We design validation protocols that generate approvable data efficiently for companion diagnostic assays and multiplex immunoassay formats.
The regulatory pathway for companion diagnostics is notably more complex than standalone diagnostics. Your submission must address not just analytical performance but clinical utility within the context of specific therapeutic decisions.
Regulatory Navigation for CDx Programs
Our regulatory team has direct experience with PMA submissions for companion diagnostics, including:
- Pre-submission meetings with FDA to establish validation requirements and study designs
- Technical file build incorporating both analytical validation data and clinical trial performance
- Stability studies designed to support shelf-life claims matching therapeutic product timelines
- Post-approval change management as drug indications expand or manufacturing processes evolve
We understand that notified body approval for CDx products isn’t just about meeting minimum technical requirements. It’s about building a compelling case that your test reliably identifies patients most likely to benefit from the associated therapy in precision medicine companion diagnostics applications.
Manufacturing Designed for Therapeutic Launch Scale
Companion diagnostic manufacturing faces unique challenges compared to standalone diagnostic tests. Your volumes must align with drug launch projections, often requiring rapid scaling from validation batches to commercial production measured in hundreds of thousands or millions of tests annually. Supply interruptions aren’t just business problems – they directly impact patient access to potentially life-saving therapies.
Our manufacturing approach addresses these realities:
Scalable Processes from Development
Manufacturing considerations inform development decisions from the outset. We design immunodiagnostic assays that can be manufactured consistently at scale, not just produced successfully in small research batches.
Flexible Capacity
Our dual-facility strategy (Madison, Wisconsin and York, UK) provides manufacturing redundancy and geographic flexibility. If tariffs, regulatory requirements, or supply chain considerations favour one location over another, we can accommodate shifts without process revalidation.
Quality Systems Built for FDA Inspection
ISO 13485-certified quality management systems with documented design controls, process validations, and post-market surveillance capabilities. Our quality infrastructure meets FDA expectations because it’s built on that foundation, not retrofitted to minimum compliance levels. As one of the top lateral flow CDMO companies specialising in IVD development, we understand the unique requirements of developing in vitro companion diagnostic devices.
We provide realistic assessments based on direct experience with similar programs. If we don’t believe we can deliver what your program requires, we’ll tell you directly and explain why – that honesty early saves everyone time and resources.
Case Example: Immunology CDx Development Program
A pharmaceutical company developing a novel immunotherapy approached us after preliminary biomarker identification in clinical samples. Their challenge: translate a research-grade immunoassay into a companion diagnostic device suitable for FDA approval and commercial launch aligned with their drug approval timeline.
The Solution: Our team developed a lateral flow immunoassay format optimised for the required sample type, designed validation studies that generated approvable analytical and clinical performance data, and established manufacturing processes capable of scaling from clinical trial supplies through anticipated commercial volumes.
While we cannot disclose specific customer names or proprietary details, this example illustrates our approach: technical expertise combined with regulatory knowledge and manufacturing capability, all coordinated under integrated project management. Refer to our Case Studies page for further examples.
Start With a Technical Feasibility Assessment
Companion diagnostic projects require careful evaluation before significant investment occurs. Not every biomarker concept translates successfully into a manufacturable diagnostic format. Not every lateral flow architecture can meet the performance requirements your clinical program demands.
Our initial consultation as your CDx development partner addresses these fundamental questions:
- Is your biomarker concept compatible with lateral flow technology given sample matrix and performance requirements?
- What regulatory pathway and validation strategy will notified bodies expect for your device’s intended use?
- What timeline and cost structure should you anticipate from feasibility through approval?
- What manufacturing considerations will influence development decisions?
Abingdon Health is proud of being approachable and values its long-term collaborative partnerships. Dedicated account managers and experienced teams of R&D, tech transfer and manufacturing experts work hard to ensure the delivery of optimum rapid test solutions for the life cycle of product portfolios.
We’re passionate about imparting our knowledge and expertise to help you hit your goals.
Contact our team to see how can take your CDx assay from idea to commercial success.
