Biomarker Development

Testing Services to Support Your Preclinical and Phase I-IV Drug Programs

Nexelis provides biomarker assay services in inflammation and immunology, oncology, organ injury (renal), nutritional health, cardiovascular, metabolic (NASH/NAFLD) and infectious diseases. Our scientists approach your projects with flexible and creative solutions, developing fit-for-purpose to validated assays that support your protocol.

With 30+ years of experience, our CAP/CLIA-certified laboratory offers biomarker testing services to aid our pharmaceutical and biotech client programs from preclinical through Phase IV. With our vast experience in biomarkers to guide your program by offering direction on the best assay for your primary, secondary, or exploratory endpoints for your clinical trial. 

We perform multiplex assays to measure numerous analytes in a single sample, increasing the speed and throughput, as well as optimizing sample volume. This significantly increases the efficiency when generating critical sample data. Nexelis’ vast history means we established best practices and strategies to troubleshoot or optimize low performing assays and execute assays with low sample volume pipetting techniques. Our validation procedures apply to our menu of available assays and novel biomarkers. You can also rely on our expert data analysis and reporting.

Whether it is routine, customized, or an esoteric assay, our scientists can help you.

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CAP/CLIA Labs for Biomarkers Analysis

Whether you’re identifying inflammatory cytokines and chemokines, hormones, tumor antigens, or angiogenesis biomarkers, look to our extensive biomarker portfolio. Nexelis clinical biomarker services provide both off-the-shelf and custom assay options to aid in your drug development. Our scientific team works collaboratively with our sponsors to select or design the biomarker best suited to their program.

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Key Therapeutic Areas for Biomarker Services

Organ Specific/Injury

Nexelis has assessed renal toxicity (AKI) for over 40 drug programs since 2010. Our FDA-qualified tubular injury safety biomarker panel was approved for Phase I trials to aid in the detection of kidney tubular injury. This new gold standard includes six urinary biomarkers: Clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-beta-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and Osteopontin (OPN).

Immuno-Oncology

Global preclinical and clinical exploratory solutions, decades of experience, and multiplatform approaches improve decision-making in your oncology development program. Rely on our comprehensive portfolio of biomarker assays for cytokines, chemokines, inflammatory markers, cellular pathway targets, and immuno-oncology multiplex panels.

Metabolism and Inflammation

We participated in more than 35 studies (Phase I-III) in the last four years with a NASH or related indication (primary biliary cirrhosis, chronic hepatitis B, alcoholic hepatitis, hepatobiliary disorders). Among other areas, our expertise includes:

  • NAFLD/NASH and other dyslipidemias
  • Insulin Resistance and Type 2 Diabetes Mellitus (T2DM)
  • Obesity
  • Gut hormones

Infectious Disease

From recent acquisitions to our award-winning work on SARS-CoV-2, Nexelis continues our long-standing dedication in developing biomarker assays for measuring inflammatory response in various infectious diseases and vaccines. We continue to invest in our laboratories and expand our biomarker portfolio for infectious diseases.