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Fit The Curve Blog

State of bioanalytical microsampling

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Home / Blog / State of bioanalytical microsampling

Did you know there are now over 40 commercially available technologies for patient-centric blood sampling, focusing on microsampling rather than traditional venipuncture and vacutainers? I would have guessed less than half that number if I hadn’t consulted the Patient Centric Sampling Interest Group website. I suspect there have been one or two new additions to the technologies listing since last year as well.

 

This highlights the current activity in our bioanalytical community around microsampling in the clinical space. Recently, the PBSS Online Symposium “Patient Centric Blood Sampling for Facilitating Decentralized Clinical Trials” provided an engaging overview of the potential for clinical microsampling:

 

  • Reduction in patient burden
  • Obtaining additional data for PK and biomarkers
  • Collecting data from challenging clinical events (e.g., migraine, asthma, epilepsy, adverse events)
  • Improved clinical trial recruitment (e.g., diversity and timelines)

 

The symposium also addressed the challenges of bridging capillary whole blood micro-samples to traditional bioanalytical samples (e.g., for PK assay support), as well as laboratory and collection/shipping logistics and metadata integrity. However, it was encouraging to hear the enthusiasm from the regulatory perspective (FDA) for patient-centric sampling and decentralized clinical trials. This motivates us to persevere and tackle the remaining obstacles to make microsampling a routine bioanalytical strategy.

 

If you’re looking for a resource on clinical microsampling, I highly recommend visiting the PCSIG website and exploring the content. There are also a couple of upcoming free webinars in November and December that can help you stay updated on progress and practical applications.
Stephen Lowes, Ph.D.
Stephen Lowes, Ph.D.

Senior Director, Bioanalytical Services Welcome! I'm Steve Lowes, and I'm thrilled to share my journey, thoughts, and insights with you through this blog. As the Senior Director of Scientific Affairs at IQVIA Laboratories in Ithaca, NY, I've dedicated over 30 years to the fascinating field of regulated bioanalysis. Throughout my career, I've had the privilege of presenting at numerous conferences and authoring publications that aim to advance our science and foster dialogue within our discipline. I'm proud to be the co-editor of the book "Regulated Bioanalysis: Fundamentals and Practice," and I enjoy sharing my knowledge and experience from the lab, as well as troubleshooting bioanalytical data. Recently, my interests have focused on the exciting applications of LC-MS in modern drug modalities and biomarker bioanalysis. This has expanded into biologic molecules, adding new dimensions to the future potential and importance of the bioanalyst's role in bringing safe and effective therapies to market. Outside of work, I cherish life with my wife and two wonderful teenage daughters. You can often find me fly fishing on trout streams and salmon rivers or hiking the beautiful gorges and forests of central NY with my black Labrador, Josie. I look forward to diving into and exploring current bioanalytical topics and more with you!

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