Nightingale for clinical trials

Use Nightingale’s biomarkers and risk scores to understand the effects of interventions on disease risk and progression, and stratify trial participants to gauge personalized differences in response.

Nightingale provides a robust biomarker platform widely used in population cohorts and intervention trials with over 1 million samples profiled to date. Examples of profiled randomized trials include various lipid-lowering and antidiabetic drugs, specific nutritional interventions, and broad lifestyle interventions in at-risk populations. Published projects have demonstrated the relevance of Nightingale's metabolic biomarkers for the molecular understanding of disease and risk prediction. Furthermore, these studies have highlighted novel beneficial effects of the interventions for multiple metabolic pathways.

The existing results database from large observational cohorts enables you to put your findings into context and rapidly interpret your intervention effects in terms of health impact by either using individual biomarkers as well as our validated multi-biomarker scores. The robust, batch effect free and scalable nature of the Nightingale method combined with the affordable price allows you to rapidly profile all samples in your trial and save sample material.

How Nightingale's biomarker profiling benefits your clinical trial

250 biomarkers analyzed from a single sample

Nightingale's biomarker panel covers 250 biomarkers, from a single blood sample, of which 39 are clinically validated. The panel includes routine lipids, apolipoproteins, amino acids, fatty acids, lipoprotein particles, inflammation and glycolysis-related metabolites, and many more. These biomarkers reflect the physiology of a plethora of diseases and provide a snapshot of human health.

Obtain dozens of clinical grade biomarkers from one sample in one go

Unlike in routine clinical chemistry, with Nightingale's technology, 39 clinically validated biomarkers are analyzed simultaneously from one sample. Our laboratory has similar quality assurance as any other clinical laboratory and our biomarker measurements are provided in the same format (absolute concentrations) as traditional clinical chemistry measurements. Thus, you can obtain several clinical-grade measurements at once, save precious sample material and receive your results rapidly.

Interpret data from multiple time points with no concern for batch effects

Existing publications and the ongoing UK Biobank analyses have repeatably demonstrated the absence of batch effects and the robustness of our platform to track even subtle intervention effects over several timepoints – a technical challenge facing most other multi-biomarker platforms. Since the entire sample process is highly automated and scalable, we can deliver results rapidly; thousands of samples in a few weeks. Furthermore, we also provide tools for data analysis. Together, these features enable you to measure each time point immediately after sample collection and thus speed up your data analysis.

Utilize multi-biomarker risk scores instead of single biomarkers

Nightingale’s data from multiple large-scale general population cohorts have helped to generate multi-biomarker risk scores with better prediction power than the current commonly used scores. Nightingale’s risk scores can currently be used for the prediction of CVD and type 2 diabetes. Thus, utilizing Nightingale’s risk scores allows you to rapidly understand the effects of your intervention on disease risk and progression and stratify trial participants to gauge personalized differences in response.

Analyze actionable biomarkers to understand true physiology and disease mechanisms

Nightingale’s biomarkers are very sensitive and respond rapidly (in a matter of weeks) to drug and lifestyle interventions. Additionally, the absence of sample extraction in our analysis allows for the preservation of physiological lipoprotein particles integral to chronic diseases and accurately tracking the response to lipid-lowering medication and lifestyle interventions.

Put your findings into health outcome context and get ideas for new trials

The existing results from the UK Biobank and other large observational cohorts can greatly benefit clinical trials by providing information on the associations between each biomarker in the Nightingale panel and future risk for all common diseases, with immense statistical power. This gives you a head start: since all the biomarker-disease associations are known, it allows you to directly interpret your intervention effects in terms of health impact and future health consequences. Your study can also benefit from the metabolite-genome sequencing results from the UK Biobank since these allow you to focus on the genotypes with firmly validated metabolite relations and study these with sufficient power to understand potential genetic differences of your intervention effects. Furthermore, you can use our affordable, high-throughput profiling in your entire trial to select other relevant, but more costly assays for downstream applications.

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