Science that turns care into reality.

Investigating takes curiosity, method and a willingness to revisit hypotheses. Experimenting takes the courage to explore possibilities and the responsibility to assess risks. Moving forward means measuring, comparing, documenting and learning, including when the results do not match what we expected.

We do not mistake innovation for evidence, or technological potential for demonstrated performance. We distinguish between what we know, what the data support and what still needs to be investigated.

We report results according to what was measured and to the limits of the method. We do not stretch conclusions beyond the evidence, treat hypotheses as established facts or present a possibility as a capability that has already been demonstrated.

This responsibility is part of technology development itself. Clarity does not begin with the message that reaches the user; it begins with the questions we ask, the data we produce and the way we assess each result.

Designing for the point of care means considering the real conditions of use: sample collection and preparation, training, setting, time, available resources and integration into the healthcare routine. The experience should be simple and human, without removing steps or information needed for correct use.

That is why we develop in collaboration. Materials science, chemistry, engineering, electronics, software, clinical practice, manufacturing and user experience all need to contribute so that each solution works as a system. Shared knowledge broadens our ability to identify problems, weigh alternatives and improve the end result.

Our commitment to people also shows in how we work: sharing knowledge, welcoming feedback, supporting each professional's development and taking responsibility for what we deliver.

Excellence does not mean assuming we have reached the definitive solution. It means assessing performance, correcting failures, improving processes and pursuing quality with efficiency and with social and environmental responsibility.

A test result should be made available clearly, respecting its purpose, its conditions of use and its limits. When clinical interpretation is needed, it remains tied to each person's context and to the assessment of the healthcare professional.

Biosens exists to develop the technology that brings results closer to where they can contribute to care. We want to be part of a future where science transforms how we care, with solutions built on rigor, integrity, collaboration and continuous improvement.

REASSURED is a set of characteristics proposed in the scientific literature to guide the development of point-of-care tests. It extends the ASSURED framework, formulated under the World Health Organization's TDR program in 2003. In 2019, Land and colleagues proposed the REASSURED extension, adding real-time connectivity and ease of specimen collection.

The framework was developed with particular attention to the diagnostic needs of infectious diseases in resource-limited settings. Applying it to other purposes, such as monitoring chronic conditions, requires considering the intended use, the characteristics of the test and the context of use.

The nine criteria raise questions that matter for development:

• R

  Real-time connectivity.

  How can results and data reach, when needed, the systems and people permitted to use them?

• E

  Ease of specimen collection.

  Are collection and preparation suited to the purpose and to the real conditions of use?

• A

  Affordable.

  Is the cost viable for the user and for the health system in the intended context?

• S

  Sensitive.

  Has the performance in detecting the target been adequately characterized, considering the risk of false-negative results?

• S

  Specific.

  Has the performance in distinguishing the target from other relevant conditions been characterized, considering the risk of false-positive results?

• U

  User-friendly.

  Have the steps, instructions, training needs and possible use errors been considered?

• R

  Rapid and robust.

  Is the time to result appropriate, and does the test withstand the expected conditions of transport, storage and use?

• E

  Equipment-free or simple, environmentally friendly.

  Is the reliance on equipment appropriate to the context? Are materials, disposal and environmental impact considered?

• D

  Deliverable to end-users.

  Do distribution, supply and the operational structure allow the test to reach the people who are meant to use it?

These criteria are not a certification standard, nor do they show, on their own, that a product is fit for use. Nor do they necessarily carry the same relevance or weight in every context. Analytical performance, cost, speed, simplicity, specimen collection, robustness and conditions of use can involve trade-offs that need to be assessed for each purpose.

For Biosens, REASSURED is a reference for asking questions, weighing alternatives and guiding design decisions. It is not a claim of compliance or an achievement taken for granted. Every capability has to be demonstrated by evidence appropriate to the product, its intended use and the conditions in which it will be used.