Behavioral Diagnostics and Versiti are partnering to provide objective DNA methylation assays that can improve participant screening and data interpretation.
Behavioral Diagnostics and Versiti Clinical Trial Solutions have announced a partnership to offer epigenetic assays for cancer risk, smoking, and alcohol exposure screening within clinical trial support services.
The collaboration aims to help trial sponsors identify behavioral factors that influence trial safety, participant retention, and data interpretation. By using DNA methylation-based biomarkers, the assays provide biology-based measures of risk for lung cancer and heavy alcohol use, reducing the reliance on self-reported data.
“Clinical trials depend on clean, interpretable data,” says Doug Rains, chief scientific officer, Versiti Clinical Trial Solutions, in a release. “By adding Behavioral Diagnostics’ screening technology to our clinical trial support capabilities, we can help sponsors better understand participant risk factors that may influence safety, adherence and study outcomes.”
The smoking-related assay measures methylation at cg05575921. Research published in the journal Lung Cancer indicates that including these methylation levels with clinical and smoking-history variables in subjects from the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial improved the prediction of lung cancer in current or former smokers compared with existing methods. The Smoke Signature CA test also provides an assessment of smoking intensity for use in precision medicine smoking cessation therapies.
The alcohol assay generates an Alcohol T Score to measure heavy alcohol consumption. Unreported alcohol use in trials can lead to drug-alcohol interactions, medication nonadherence, and variability in safety and efficacy signals.
“Self-report has long been a limitation in assessing behavioral exposure,” says Robert Philibert, MD, PhD, chief medical officer and founder, Behavioral Diagnostics, in a release. “Our assays are designed to give sponsors objective biological information that can support more informed trial design, monitoring and interpretation.”
Versiti Clinical Trial Solutions will use these assays for participant screening, baseline risk assessment, and longitudinal monitoring of behavioral exposure to support the development of cleaner clinical trial datasets.
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