Resources:
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- https://www.ascilion.com/
This episode explores the future of skin biomarkers. Featuring insights from Simon Grant, CEO of Ascilion, and Théo Boyer, Senior Project Coordinator at Indero, the episode examines how dermal interstitial fluid (d-ISF) could revolutionize dermatology. Our guests illuminate the potential of ISF sampling, paving the way for more personalized and innovative approaches to care.
Simon Grant, CEO at Ascilion
Simon Grant has extensive experience in medical devices and identifies significant, untapped potential in d-ISF. ISF contains nearly all blood biomarkers but is challenging to access. Ascilion specializes in extracting ISF in a non-traumatic and repeatable manner, providing real-time insight into the body’s status. This technology enables measurement of thousands of biomarkers for skin diseases and also for cardiovascular conditions, hormones, and other health indicators. ISF reflects most blood biomarkers, including molecular ones such as glucose, hormones, and cardiovascular markers. Simon Grant believes ISF sampling will become widely adopted, offering a minimally invasive way to monitor health.
Théo Boyer, Senior Project Coordinator at Indero
Théo Boyer has 10 years of academic experience in biochemistry and molecular medicine. He believes that future innovations, such as the Ascilion technology, will significantly impact the field. Over the past year, he has contributed to several early phase clinical trials, gaining insights into their unique challenges and the value they bring to clinical research. Théo’s strong academic background gives him a clear grasp of study objectives, while his hands-on project management experience at Indero enables him to tackle these challenges effectively and efficiently.
Connecting Through Innovation
The collaboration between Indero and Ascilion began when a joint customer introduced an exciting opportunity. A client was interested in measuring skin activity without resorting to biopsies or tape stripping, which led both teams to explore a promising new method. Recognizing the innovative potential of the project, Théo was assigned to join the effort. After the project’s initiation, Théo and Simon met in person at the SID annual meeting last May, which provided a valuable chance to discuss the technology and deepen their partnership.
Understanding Dermal Interstitial Fluid
ISF acts as a bridge between the circulatory system and cells, facilitating the passage of nutrients to cells without direct transfer from blood. This fluid expresses nearly all blood biomarkers, enabling the measurement of most biomarkers present in blood through ISF. It transports substances to and from cells and the circulatory system. The body contains more than twice as much ISF as blood but accessing it remains a significant challenge.
Innovations in Minimally Invasive Skin Sampling
The concept originated from recognizing an untapped method for accessing biomarkers in the body. Continuous glucose monitoring serves as an example, as it measures glucose in ISF rather than blood, since continuous blood measurement is challenging. ISF reflects blood content but avoids the complications of blood sampling. Continuous glucose monitoring represents the first major application of ISF, demonstrating its popularity. ISF contains thousands of biomarkers found in blood, offering a minimally invasive approach to access these indicators. The current gold standards for evaluating these biomarkers involve biopsies or tape strip samplings.
Advantages
A microneedle array equipped with extremely fine microneedles gently penetrates the epidermis and reaches the upper dermis, extending only about a third of a millimeter into the skin. This technique causes no pain and results in significantly less trauma compared to traditional biopsies or tape stripping. Its excellent tolerability allows for repeated ISF sampling from the skin, ensuring strong patient compliance, unlike biopsies, which are restricted by their invasiveness. Clinicians widely recognize this approach as far less intrusive than conventional alternatives. Furthermore, ISF sampling enables the monitoring of localized changes in the skin, offering distinct advantages for both research and ongoing health assessment. The blend of minimal invasiveness and repeatability positions this technology as a promising solution for future applications.
Challenges
Current technology development emphasizes both efficiency and ease of use, with sample collection typically requiring just 15 to 20 minutes to yield sufficient ISF for analysis. Efforts are continually underway to increase sample volume and further streamline the extraction process. At the same time, achieving validation and broad scientific acceptance of this novel data type remains a key objective. The ongoing contribution of 18 simultaneous trials is providing valuable evidence about ISF composition and its potential to enhance our physiological understanding. The practice of regular molecular biomarker monitoring, well established through continuous glucose measurement, has already shown significant value in diabetes management, and there is a growing demand for similar approaches to track additional biomarkers such as cortisol and progesterone. Anticipated advances will soon enable routine measurement of both traditional and molecular biomarkers, seamlessly integrating diverse data sources to provide comprehensive health insights. Ultimately, this shift will transition testing from exclusive laboratory or hospital settings to routine use in clinical environments and even at home. Continued progress strives to deliver the data and tools necessary to fully realize the promise of these innovations.
Target Dermatology Conditions
Ascilion’s customer base spans a diverse range of fields, including hormone and cardiovascular research, with at least 1/3 focusing on inflammatory skin diseases. Frequently studied conditions include atopic dermatitis (AD), prurigo nodularis, psoriasis, and seborrheic dermatitis. Research in this area typically follows 2 main approaches: quantifying biomarkers in healthy skin and comparing them to those found in lesions, such as those present in AD. While measuring biomarker changes in lesions presents challenges, ongoing studies continue to advance our understanding of conditions like AD and psoriasis.
This innovative technique empowers clinicians to investigate skin conditions non-traumatically, eliminating the need for biopsies. By sampling ISF from lesions, the areas surrounding lesions, or healthy skin, clinicians can directly compare biomarker profiles, gaining deeper insights into disease progression. Recent data demonstrates that ISF serves as a robust medium for examining skin activity, particularly in evaluating bioavailability.
In addition, oral drug pharmacokinetic (PK) studies greatly benefit from ISF sampling, as it allows for the measurement of drug presence in the epidermis and comparison of these levels to those found in blood. This is especially valuable for pharmaceutical companies, as it helps determine the efficiency of drug delivery to the dermis and assess the impact on relevant biomarkers. This method allows for frequent, non-destructive sampling of the thousands of biomarkers found in ISF, including hormones, drugs, proteins, and peptides, making repeated measurements during studies like PKs possible, unlike traditional biopsies or tape stripping. Ultimately, this minimally invasive approach broadens the potential for targeted biomarker analysis and advances PK studies in skin research.
Condition-Specific Challenges
Sampling requires access to a relatively flat area of skin. Sampling from bony or uneven regions, such as fingers or the back of the hand, presents challenges. Sampling is possible from most body areas, including the scalp after a small area is shaved, which may be useful for conditions like alopecia areata. The palms and soles are typically unsuitable due to the thickness of the skin. Older patients often yield larger sample volumes, although variation occurs between subjects. Average sample volume is currently 15 microliters in 15 minutes, which is sufficient for numerous analyses and represents improvement over previous years. Method selection must consider volume requirements for specific analyses, such as proteomics studies that need only a few microliters. Support is provided throughout the process to ensure studies are structured for optimal results.
Multiple indications can benefit from this technology due to the ability to sample various areas. Analysis sensitivity depends on the biomarker, but results have shown high reliability. This approach enables real-time monitoring of biomarkers with minimal skin trauma, using microneedles that penetrate only 1/3 of a millimeter. The technology is applicable beyond dermatological indications, including cardiovascular and hormone studies, such as large-scale cortisol research conducted entirely through skin sampling. Most biomarkers are detectable in ISF, and ongoing research aims to correlate skin levels with systemic levels. Future developments are expected to link ISF findings to broader health monitoring, enabling non-laboratory, real-time measurement. Current efforts focus on clinical trials and knowledge development, with the expectation that ISF sampling will become integral to wearables, molecular diagnostics, and biomarker monitoring.
Applications
This technology offers broad application with significant value for studies, particularly as a replacement for traditional sampling methods such as tape strips and biopsies commonly used in clinical trials. Biopsy recruitment presents challenges due to participant reluctance and increased infection risk. The minimally invasive nature of this method facilitates equipment use and study execution. Obtaining ethical approval for multiple biopsies has become increasingly challenging, as regulatory agencies now advise limiting biopsy use to cases where it is absolutely necessary. The method provides a more favorable pathway for regulatory and ethical approval. Accessibility of biomarkers in ISF opens new possibilities, as certain biomarkers are inaccessible in blood. Innovation in this technology enhances the value of clinical trials. Looking ahead, ISF extraction for analysis will continue, with growing interest from companies and researchers in microinvasive measurement methods that do not require blood sampling. If biomarkers are reflected in ISF, the technology presents clear advantages. The market trend indicates increased demand for monitoring diverse biomarkers, expanding beyond metabolic health applications such as continuous glucose monitoring. Extracting ISF enables access to thousands of biomarkers without multiple sensors. The system is designed for versatile use, supporting various applications. Anticipated growth in molecular biomarker monitoring will position this technology as central to future developments in the field.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
