Randox CDx Capabilities

Randox Molecular MachinesThe Precision Medicine concept has significantly changed the way drug development is being handled and companion diagnostics have come to the forefront of medical innovation, by enabling targeted treatments in a variety of therapeutic areas.

Assay development skills, Market access capabilities and Regulatory competencies are the key elements to bring a drug-tailored assay to life, built to Sponsor’s specifications and delivered on time to support the successful release of the newly approved drug. With a long recognized expertise in the development of esoteric assays, and more than 500 IVD products available globally, Randox is a partner of choice to support your CDx needs, primarily but not only in the field of Immuno-assays.

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 can be your CDx and biomarker assay development partner from early phase trials right through to drug launch, addressing all assay requirements in between, including, development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.

Examples of Assay Development at Randox

IL-22 Assay

Interleukin 22 (IL-22), initially associated with inflammatory processes through the activation of the TH17 pathway, has more recently been shown to protect against epithelial cell damage in a variety of organs including liver, pancreas, gut, kidney and lung. This has triggered a revival of interest for IL-22 as a biomarker, as well as a therapeutic agent. Randox have developed an IL-22 assay to a CTA grade under full design control, ready to support IL-22 assessment in phase II-III stages of clinical development.

Key benefits of the IL-22 assay include a highly sensitive LOQ from 0.1 pg/ml (Biochip 4 plex) to 1.4 pg/ml, an established assay range from 1.4 to 100 pg/ml (automated platform), no significant interference and the availability of control & calibrator material.

ApoE4 2-plex array

The apolipoprotein E4 (ApoE4) gene is established as the strongest genetic risk factor for Alzheimer’s Disease (AD). Assessment of ApoE4 allele expression is a powerful tool for AD risk prediction enabling stratification of at-risk populations.

At Randox Laboratories, we believe that measuring ApoE4 protein expression in plasma is the way forward to screen those individuals at increased risk of Alzheimer Disease, as new beta amyloid-targeting therapies for this condition are being expected.

The ApoE4 2-plex Array simultaneously measures both total ApoE and ApoE4 protein levels directly from a blood plasma sample and has 100% concordance to genotyping methods. The Apo E4/total ApoE ratio can classify the ApoE4 status of the plasma sample as negative or positive.

Furthermore, the Array has demonstrated potential to classify ApoE4 positive plasma samples as being derived from a heterozygous (one copy of ApoE4 gene) or a homozygous (two copies of ApoE4 gene) individual.

The key benefits of the ApoE4 2-plex arrays is the cost effective and efficient multiplex testing over other ELISA or PCR methods, limited sample volume and handling requirements and an assay time within 3 hours.

To learn more about Randox's CDx capabilities, visit their website or contact them at info@randoxbiosciences.com.