New technologies and IVD capabilities

Molecular and hybrid lateral flow, biosensors, novel labels and multiplex formats, taken from feasibility to an IVD product that can be made at volume.

New technologies

Lateral flow is still the quickest route to a simple, low-cost result. Some clinical and field questions need more, though: a lower limit of detection, a measured value rather than a yes or no, a nucleic acid target, or several analytes from one sample. Programmes often stall here, because the technology they need sits between platforms.

We bring the same design-for-manufacture discipline to emerging formats that we apply to established ones. Feasibility work gives you an honest view of which format will meet your claims, and a development plan that a production line can actually follow.

New technologies and IVD capabilities

Molecular and hybrid lateral flow

Pairing nucleic acid amplification with a lateral flow read-out gives molecular-level specificity in a simple, near-patient format.

Nucleic acid lateral flow test customisation

Abingdon Health’s assay development experience combined with a flexible manufacturing capacity means single or multiple target nucleic acid lateral flow tests can be produced to specific specifications and volumes. We are delighted to be supporting decentralised molecular testing with the provision of straightforward nucleic acid companion diagnostics.

Biosensors

Electrochemical and optical biosensors can deliver quantitative results from small sample volumes. We support feasibility, prototyping and the material and process choices that decide whether a biosensor can be made consistently at scale.

Novel labels and nanoparticles

Beyond colloidal gold, carbon and latex, we evaluate new labels and nanoparticles, including through university research partnerships in the US, to lift sensitivity without making the test harder to use.

Not sure which format fits your target?

Our feasibility studies compare options against intended use, sample type and cost of goods before you commit to full development.

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Helping you achieve your goals

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 we can take your assay from R&D to end-users.

Companion diagnostics

Accelerating your CDx path to regulatory approval

Integrated companion diagnostics development and manufacturing. Diagnostics expertise from biomarker validation through FDA approval and commercial launch.

Companion diagnostics (CDx) represent one of the most technically and regulatorily complex pathways in the diagnostic industry. The coordination required between drug development programmes, 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.

Lateral flow is not always the right answer for a CDx claim. Where a programme needs quantitative results or a nucleic acid target, we assess molecular and reader-based formats in parallel during feasibility.

Scientists working in the development laboratory

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 programme. 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 programmes 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.

  1. Step 1 of 4: 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.

  2. Step 2 of 4: Assay development & optimisation

    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.

  3. Step 3 of 4: 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.

  4. Step 4 of 4: Analytical & clinical validation

    Comprehensive validation & verification 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.

    Clinical performance studies can also be designed and run through Abingdon Analytical, keeping analytical and clinical data in one traceable record.

Regulatory navigation for CDx programmes

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.

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 regulatory 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.

Scientist pipetting onto a lateral flow strip
Case example

Immunology CDx development programme

We provide realistic assessments based on direct experience with similar programmes. If we don’t believe we can deliver what your programme requires, we’ll tell you directly and explain why. That honesty early saves everyone time and resources.

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. 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 programme 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 regulators 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?

Quality and accreditations

Abingdon Health is certified to ISO 9001 and ISO 13485, and is compliant to FDA 21 CFR 820 (QMSR) and GMP. Abingdon Health also meets regulatory requirements of UK MDR 2002, the IVDD 98/79/EC and the IVDR 2017/746. In addition, our facilities have an establishment registration with the FDA.

From the Knowledge Centre

Read more on New technologies and IVD capabilities

Practical guidance from the specialists who deliver this work every day.

Article Innovation in Signal Generation: Labels Lateral Flow Market 2.0: CEO, Chris Yates highlights the increasing range of labels used within lateral flow tests to drive improved performance. 1 Mar 2023 · 5 min read

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Case study

MiraVista Diagnostics Assay Development for Systemic Mycoses

Discover how Abingdon Health partnered with MiraVista Diagnostics on lateral flow assay development, manufacturing and CDMO services.

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Talk to our CDMO team about your programme

Contact our team to see how we can take your diagnostic from idea to commercial success.

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