bSens.INR
Coagulation · PT/INR
In preparation for registration
Care. Anytime. Anywhere.
bSens.INR is in preparation for the Anvisa registration process. It is not yet on sale.
bSens.INR, the first test on the bSens platform.
bSens.INR
In preparation for registration- What is it?
- Point-of-care strip test that uses graphene to measure prothrombin time, expressed as the PT/INR value (International Normalized Ratio).
- What does it measure?
- bSens.INR measures clotting time from a single drop of blood, on the bSens One reader. INR is a value related to blood clotting.
- How does the measurement work?
- In three steps, from the drop to the INR value, described just below.
- What does the reader show?
- The bSens One reader shows only the measured INR value.
- What stage is it at?
- bSens.INR is being prepared for the Anvisa registration process and is not available for sale. bSens.INR performance data are not public yet. See what is done and what is in progress
- Where can I ask for more?
- Health professionals, institutions and partners can write to Biosens to see the system or request the technical material.
bSens.INR reports the measured INR value. The healthcare professional interprets the value in the context of the individual patient and the applicable clinical workflow.
How it works
Three steps between the drop and the result.
bSens.INR is designed to take the coagulation test (INR) from the laboratory to where care happens.
- 1
Prepare the strip and the sample.
The bSens.INR strip goes into the bSens One reader, which gets ready to measure. One drop of blood goes on the sample area, at the tip of the strip.
- 2
Measure clotting time.
The drop reacts with the chemistry on the strip, and the printed electrode turns the reaction into a signal. The reader measures that signal and calculates INR.
- 3
Read the INR value.
The reader shows the measured INR value. Its interpretation depends on each person's clinical context and is made by the healthcare professional.
INR
2.4DEMO
Behind the three steps are the layers of the platform: the strip's chemistry and electrode, the bSens One reader and the software that calculates INR. bSens Cloud, for the history of results, is in development. See the platform layers
bSens platform
We build every layer, from biomarker to app.
A measurement passes through five layers, from the biomarker to the reader's software. The sixth, bSens Cloud, is in development. When all of them are ours, we know where every number on the screen comes from.
Biomarker: What the drop reveals. For bSens.INR, clotting time.
Reagent: The chemistry on the strip that reacts with the sample.
Electrode: The sensor printed on the strip that turns the reaction into a signal.
Device: The bSens One reader, which takes the strip and runs the measurement.
Firmware: The reader's software, which reads the signal and calculates INR.
Cloud: bSens Cloud, in development, designed to keep each result in a history over time.
One platform, designed for several tests.
The same reader and the same architecture are designed to grow from INR to other tests.
TRL, or technology readiness level, is a scale from 1 to 9 that shows a technology's stage of development. It does not indicate how a test performs.
bSens.LAC
Lactate
RoadmapTechnology readiness level 5 of 9Lactate, planned for the same bSens One reader and architecture.
bSens.SYPH
Syphilis
RoadmapTechnology readiness level 5 of 9A point-of-care strip test with nanoparticles, in development for syphilis.
bSens.SMA
Spinal muscular atrophy (SMA)
RoadmapTechnology readiness level 4 of 9A point-of-care strip test with single-domain antibodies, in development for spinal muscular atrophy.
bSens.CARBA
Carbapenem-resistant bacteria
RoadmapTechnology readiness level 3 of 9A point-of-care strip test with CRISPR, in development for carbapenem-resistant bacteria.
For whom
One platform, five conversations.
Choose the path that describes you and see what to ask Biosens.
For patients and caregivers
If you take the coagulation (INR) test, you know the weight of the blood draw, the wait and the trip to the lab. bSens.INR measures coagulation from a single drop of blood and shows only the measured INR value. INR is a value related to blood clotting, and it is interpreted by the healthcare professional, in the context of each person's clinical situation. bSens.INR is not on sale yet.
Ask what the test measures, how the measurement works and what stage the product is at.
For health professionals
To assess a test, you need its intended use, method, performance data, limitations and instructions for use. Today the available technical material describes the system and the method. The intended use, the performance data and the instructions for use are not public yet.
Request the available technical material.
For hospitals, institutions and distributors
bSens.INR is not on sale yet. To plan adoption or distribution, the questions are workflow fit, training, consumables, support, supply continuity and the total cost of operation. These terms are not defined yet, and the conversation can start now.
Tell us your operation's requirements and your adoption plans.
For technology and manufacturing partners
We develop the diagnostic system as a whole, from sensing chemistry and electrode to device and software. We already make electrochemical sensor strips for research, bSens.SPEX. We can discuss architecture, interfaces, manufacturing, reliability, quality and the regulatory work behind a new test.
Propose a technical or manufacturing conversation.
For investors and strategic partners
We develop the system as a whole, from sensing chemistry to software, and we keep what is done apart from what is planned.
Today
- Biosens was incorporated in 2020, after years of research at Unisinos.
- Patent application at INPI, and the team's published research, in Publications.
- bSens.SPEX is available for research use only.
Still in progress
- bSens.INR is being prepared for the Anvisa registration process.
- bSens.LAC, bSens.SYPH, bSens.SMA and bSens.CARBA, in development, from TRL 3 to TRL 5. TRL shows the stage of development, not how a test performs.
Planned
- Demonstrate the expected performance of bSens.INR and complete the applicable regulatory milestones.
Transparency
What we can state today, and what we cannot yet.
When we show a number, we will show the method and the sample size next to it.
Today
Origin: Biosens was incorporated on 12 May 2020 at the Tecnosinos technology park in São Leopoldo, after years of research at Unisinos.
Science: The team's articles, abstracts and patent application are listed in Publications.
For research: bSens.SPEX, a standard electrochemical sensor strip, is available for research use only.
Result: bSens.INR is designed to report the measured INR value without interpreting it. Interpretation belongs to the healthcare professional, in the context of each patient.
Still in progress
Anvisa registration: The product is being prepared for the Anvisa registration process.
Availability: bSens.INR is not on sale yet.
Performance: bSens.INR performance data are not public yet. When they are, they will come with the method and the sample size.
Biosens processes and practices are developed with reference to technical standards (for example ISO 17593) and internationally recognized good practices, where applicable.
About
From research to the point of care.
Origin.
Biosens was born inside Unisinos, after years of academic research and development. It was incorporated on 12 May 2020, in a small room at the Tecnosinos technology park in São Leopoldo, Rio Grande do Sul.
Why we do it.
We want to bring diagnostic information closer to health decisions, through technology and with care. For us, care starts with measuring it right and saying where the measurement ends.
How we work.
We build every layer, from biomarker to app. We show the method and the limits. We say where we are and we do not sell what does not exist yet.
Contact
Results at the Point of Care
Get in touch to learn about the bSens system.
Please do not send health information by e-mail. Biosens does not interpret test results or guide treatment.
Address
Av. Theodomiro Porto da Fonseca 3101, Building 3, Room 1, 93022-715, São Leopoldo, RS, Brazil