T-06: Investigating the Utility of Minimally Invasive Sample Collection Technologies and Their Role in Clinical Trials

Poster Presenter

Maria Cusano

Novartis Institute of Biomedical Research
United States

Objectives

Evaluate minimally invasive blood collection devices, quantifying any discrepancies in biomarker data from the capillary blood collected vs a traditional venipuncture. Describe an approach to replacing clinic visits using these home collection devices in clinical trials.

ORAL PRESENTATION: 12:30PM

Method

Novartis is conducting a pilot study to evaluate a minimally-invasive blood sampling technologies supplied by 7th Sense, comparing the biomarker assay results of capillary blood collected to venous blood collected by a phlebotomist.

Results

We are measuring a broad panel of biomarkers (5,000 proteins) from each sample type/method using a SomaScan and evaluating which tests yield results precisely and accurately when compared to traditional venipuncture. From there, we will cross-validate this sample type and collection device for its use in a clinical trial setting. As this study is on track and actively recruiting, we will be able to share results in March of 2018.

Conclusion

In this presentation, we will discuss the findings of the pilot study. As the study is on track and currently recruiting, results will be reflected in the conclusion upon availability in March 2018. We are confident that measuring over 5,000 biomarkers with SomaScan, we will be able to gather promising results for which markers can be measured using the 7th Sense TAP device. Some of the benefits of assessing these technologies include increased patient recruitment, retention, and the simplification of trial design and conduct. Most importantly, the benefit to the patient lies in the minimally invasive, virtually painless sample collection. Patients will be able to collect the blood at home, and there is massive promise in collecting follow-up samples from patients for an extended period of time post-study conduct. Improving the patient’s experience will also encourage them to return for clinical trials in the future. Additionally, it increases pharma’s reach to patient populations in more isolated areas, facilitating the recruitment of a broader patient population.