CDx & BioPharma Services
Offering a collaborative CDx partnership approach.
As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safe development of new drugs.
We have a wide range of in-house capabilities, ranging from the selection and patenting of novel biomarkers; manufacture of bio reagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution.
Pharmaceutical and biotech companies are increasingly investing in the research and development of new therapies to address the world’s growing need for earlier and more effective patient treatment.
Randox Biosciences is dedicated to the improvement of personalised diagnostic, prognostic, and predictive assays. We aim to help Pharma Biotechs and CROs move away from a “one treatment fits all” approach and help get a better understanding of the complexity and variability of diseases and increase efficacy of treatment. A key element to realizing the potential for personalized medicine is companion diagnostic (CDx) development. Randox have key expertise in all elements of CDx and diagnostic development and offer a fully flexible partnership to accommodate your needs, providing you with tailored protein & molecular assays.
Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.
Complete CDx Partner Approach
Drug and Diagnostic Development Process Timeline
Randox Biosciences offers an extensive portfolio of over 900 products for a multitude of R&D applications manufactured under ISO13485 accreditation, including more than 500 monoclonal and polyclonal antibodies, 140 human recombinant proteins, as well as antibody fragments such as sdAbs and scFvs. In addition to our range of off-the-shelf raw materials, Randox can custom develop antibodies and proteins for use in new assays.
By using Randox antibodies, the raw material supply chain is controlled in-house which is highly beneficial for CDx development.
Randox offers a range of technologies and platforms for use in clinical trials, including our proprietary multiplex biochip technology that can be used in early exploratory biomarker stages and can be brought through to IVD/CDx grade. Biochip from high throughput to point of care technologies.
With comprehensive Original Equipment Manufacturing (OEM) capabilities, Randox can develop assays on any platform to ensure global reach.
All assays intended for IVD or CDx grade are developed under full design control and ISO13485 accreditation, and we have expertise in a wide range of disease areas and assay formats.
Randox have ISO17025, ISO15189 and GCP accredited laboratories located throughout the UK and Ireland, with US laboratories being mobilised in 2022 and 2023. Our laboratories can be utilised to meet your clinical trial and post approval sample analysis needs. We also have a strong global network with 3rd party laboratories to ensure your clinical trial requirements are met across the world.
Randox performs in depth multi lot verifications following CLSI guidelines to ensure full performance requirements are met and to support regulatory submissions and approvals. We will validate assay performance and reproducibility across multiple sites.
Highly experienced regulatory teams inhouse at Randox can prepare IVD/CDx submissions and applications for approval, thus, providing full regulatory support to help get your drug to the market as quickly as possible.
Development and regulatory teams will work hand-in-hand throughout the whole process and in collaboration with the Pharma partner, to ensure a timely submission while also keeping in line with country specific requirements.
We currently have 954 licenses across the globe and over 3800 licensed products to date, with continuous expansion ongoing including progression to IVDR regulation.
Randox endeavors to start commercialization planning early on in development to ensure all market access requirements are addressed, providing both pre and post-launch support with laboratory, clinician, patient and KOL engagement and can also conduct sample analysis at our clinical laboratories.
We have strong global laboratory and distribution networks, in-house sales and marketing teams, with operations and partners in over 145 countries.
We have capabilities in manufacturing customised sample collection kits and offer CDx specific proficiency testing programmes.
We can provide pre- and post-launch support with laboratory, clinician, patient and KOL engagement and can also conduct sample analysis at our clinical laboratories.