Tasso is a healthcare technology company pioneering remote, patient-centric solutions to improve blood testing access and compliance in clinical trials. Its flagship devices enable the virtually painless collection of clinical-grade blood samples, creating a better experience for trial participants.

In this Q&A, co-founder and CTO Dr. Erwin Berthier addresses how Tasso is driving innovation in decentralized clinical trials—from data accuracy and device usability to regulatory feedback and future expansion into rare disease and pediatric research.

Tasso says its device is virtually painless. How have you measured patient pain and anxiety compared with standard vein puncture, and what were the results?

We run comparative studies where participants undergo a Tasso collection and a traditional “gold-standard” venous draw. After each, participants rate the pain of each collection method using a standard “smiley-face” pain scale from zero to 10. On average, the Tasso+ device scores under 1, the venous draw scores between 2 and 3, and the finger stick lancets score between 3 and 4. These results have been consistent across multiple published studies. In additional to painlessness, we believe that the willingness to repeat and/or perform another blood collection later is of high importance. We ask participants whether they would use the Tasso device again, and about 95% say yes, which is a significantly higher rate than other blood collection methods.

Tasso aims to increase trial access for people in rural areas. What challenges have you seen around sample shipping and stability when patients collect at home?

The challenges vary depending on the specific biomarker being collected and the patient’s location. Some analytes are stable enough to ship via regular USPS mail, while others require tighter temperature control via packaging or logistics solutions. Geography also plays a significant role—shipping samples from remote locations or harsh climates adds complexity. Our work has also extended internationally, including to parts of Africa where logistical barriers multiply. To address these challenges, we design patient-centered programs that consider the patient’s needs for ease of shipping and the realities of the local environment impact on biomarker stability.

The company claims clinical-grade samples. How do you ensure capillary blood from your device matches the accuracy and precision of venous draws for key biomarkers?

We use protocols aligned with standards set by groups like CLIA to ensure data quality. This includes comparing capillary samples from our device with venous samples across a diverse population of users, including people who have biomarkers outside of the normal range. In addition, we validate that no artifacts are introduced by the device’s materials or lab processing steps. The overall goal is to map out any variables that could affect results and ensure they do not compromise the accuracy or precision of the data.

Many sites lack experience with self-collection devices. How does Tasso train trial coordinators and patients to use the device correctly?

Our device is intentionally designed to be intuitive for non-professional users, which helps reduce the training burden. For clinical trial coordinators, we provide a walkthrough of the Instructions for Use (IFUs) and are available to clarify any step-specific questions they might have. Sometimes clinical professionals request more technical detail, and we are happy to provide that as needed. In practice, most participants can collect their sample at a site with minimal guidance.

Regulatory authorities set strict rules on sample handling. What feedback have you received from the FDA or other agencies about using remote collection devices in trials?

We are not a pharmaceutical drug manufacturer and cannot speak definitively on regulatory policy which tends to evolve over time. We recommend that pharmaceutical partners consult the FDA during protocol design, especially if the trial endpoints or populations raise unique concerns. Nonetheless, we have been involved in many trials and have been exposed to how the technology has been implemented in trials that aimed at including patient-centric technologies and how the regulators have perceived the technology. Generally, the FDA has shown support for innovations that improve trial access and diversity, such as enabling data collection during spontaneous events, like migraine onset at home. As long as the scientific rigor is strong and data equivalence is clearly demonstrated, we have found regulators to be receptive.

The company wants to speed up timelines. Can you share an example of a trial where your device actually reduced patient visits or shortened study duration?

One impactful use case for trials that we have seen is accelerating the recruitment phase. Sponsors can use our end-to-end prescreening services to identify eligible participants more quickly from large candidate pools, which helps trials get off the ground faster. Another major benefit is reducing dropout rates by lowering the burden of site visits. We are currently gathering data on how this translates into improved retention, which makes recruitment more efficient and increases the chances of trial success. The non-profit Patient Centric Sampling Interest Group (PCSIG) has recently conducted a study comparing in-clinic sample collection to at-home for patient recruitment and retention, with quite exciting results. That publication is coming soon, but PCSIG has shared some of the data via their online channels already.

Tasso’s technology adds cost upfront. How have sponsors weighed the expense against potential savings in site staff time, travel reimbursements, and dropouts?

In many cases, sponsors find that a Tasso kit’s price is lower than what they would spend reimbursing patients for travel. The overall cost structure depends heavily on biomarker validation. If the biomarker is already validated for use with capillary blood in a central lab, the solution is cost-effective and easy to implement. If a biomarker needs new validation, there is an initial investment, but downstream savings typically can offset it. Speeding up recruitment, improving retention, and reducing trial duration all translate to meaningful financial benefits, especially given how costly delays and recruitment shortfalls can be.

Not every patient is tech-savvy. What user support systems has the company put in place for elderly patients or less literate patients?

We provide a variety of support options to meet patients where they are. Some people prefer printed instructions and find them easy to follow. Others benefit more from digital, step-by-step guides or videos that are accessible through our online portal. For patients who need more direct help, we offer live virtual proctoring sessions where a support team member walks them through the collection process in real time. This level of support isn’t just for older adults—it is available to anyone who feels unsure or wants more guidance.

Clinical trials generate large volumes of data. How does Tasso integrate its device data into existing electronic data capture systems and trials?

We use two primary methods for integration. In some cases, we work directly with the sponsor’s central lab, which is already connected to the trial’s electronic data capture (EDC) system. In other instances, we partner with labs that are integrated into broader central lab infrastructure. Either way, the data flows into existing systems seamlessly, using established, traceable pathways that meet regulatory standards. This minimizes setup time and ensures compliance from the start.

Looking ahead, what unmet needs in blood collection does the company see for rare disease or pediatric trials, and how might your technology evolve to meet them?

Rare disease trials often face significant challenges due to the geographic distance between patients and trial sites, as there is only a small population of participants to draw from. Our goal is to make it possible for these participants to complete full trial visits from home, including safety labs like complete metabolic panels (CMPs) and complete blood counts (CBCs). That is a major focus for us. For pediatric trials, we are developing child-specific collection devices that are designed with both physical and emotional comfort in mind. Parents’ concerns are front and center in our design process, and we are actively working to bring those solutions through clearance and into trials.