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November 21, 2022

Validating Our Blood Testing Innovation

By Dr. James Jacobson

At Babson Diagnostics, we pride ourselves on being a “science-first” company. What does that mean? To us, it means that everything we do is grounded in rigorous scientific research with no compromises. Our vison of reimagining blood testing to make it more convenient, less invasive, and more accessible is nothing without accuracy, quality and trust.

Our company was founded on the vision of conducting a wide range of blood tests from a microsample of blood drawn from a fingertip. No more big tubes and needles. No phlebotomist or nurse required to draw tubes of blood from a vein. Simpler, easier, and potentially less stressful blood collection means testing could be expanded to new care settings such as retail pharmacies or even at home. Blood tests that are easier to access and more affordable can have profound effects on preventive care. Each drop tells a lot about our health and about what the future may hold.

So what does this journey look like? As we have all recently learned, there’s no such thing as “fake it till you make it” when it comes to medical innovation. The gap between vision and reality can only be closed with an evidence-based approach to research and development. There are no shortcuts. We are innovating with integrity to produce accurate, repeatable results that patients and clinicians can trust to make decisions about care.

Producing technologies the right way

The process that brings a new medical service from the research laboratory to the marketplace is a long and careful one.  Careful, because we must ensure patient safety and follow strict government regulations in evaluating the safety and efficacy of the device. Long, because this takes time….

One of the most important steps in the development process is the clinical trial, which is a study with people who volunteer to have their blood collected and analyzed with our proprietary technologies. Babson has united proprietary technologies across collection, sample preparation and analysis. We are privileged to work in collaboration on these technologies with leading, global MedTech companies who share our scientific rigor: BD (Becton, Dickinson and Company) and Siemens Healthineers.

The goal of our clinical studies is to validate that the results from our blood testing ecosystem using capillary blood are equivalent to traditional analysis with venous blood, the specimen of choice for most routine laboratory tests.

Capillary blood collection has been around for decades, often used with certain patients, such as infants, the elderly and those who have veins that are inaccessible. Diabetics also routinely check their blood sugar levels with a finger stick.

Providing a broad range of tests from a finger stick presents challenges because capillary blood is not identical to venous blood and a limited amount of blood can be drawn from a finger. Capillary samples can sometimes be contaminated with other fluids if the finger is squeezed too much. This type of collection also can cause hemolysis, or the damage to red blood cells, which can affect results.

To overcome these challenges, Babson developed a technological ecosystem that represents a leap forward in each aspect of the testing process:

  • A proprietary finger-collection device, under development by BD, orients the finger-puncture in the optimal location and facilitates the collection.
  • Our sample-preparation device controls preanalytical processes, eliminates the variability of human intervention, and maintains optimal conditions at all times. This allows us to produce consistent samples that maximize quality no matter where they are collected. Test tubes are not sitting in a storage locker subject to the temperature changes and other uncontrolled variables.
  • Our CLIA-certified lab uses best-in-class analyzers and assays, including proprietary miniaturized assays, to optimize testing for each microsample.

Babson’s clinical research began in November 2015 and to date, we’ve completed 25 clinical studies involving more than 1,400 study subjects, and more than 367,000 laboratory tests. Since early 2020, I have been the principal investigator for these studies charged with conducting objective research that generates independent, high quality, and reproducible results. As principal investigator, I am responsible for the management and integrity of the design, conduct and reporting of the research and for managing, monitoring, and ensuring the integrity of any collaborative relationships.

Many of our clinical studies are taking place in retail settings, which is important for us to perfect our offering and ensure it works for the patient and the staff giving the service. We are the first company to generate large panels of test results using a capillary sample collected in a retail setting.

Our early research comparing our end-to-end ecosystem versus conventional venous blood testing gave us a lot of confidence in our science and technologies. Now we are executing studies that will support applications to the U.S. Food and Drug Administration. A part of our ecosystem that needs government clearance is the BD capillary blood collection device.

We are executing four studies of the BD capillary blood collection device:

  1. The first is to show clinical equivalence across a range of conditions.
  2. Once we collect samples, we are evaluating them to ensure they remain stable in the sample preparation device as well as during the time it takes to transport to the lab. We refer to this study as the analyte stability study.
  3. The third study was designed to detect if there are any differences in the test results based on who collected the sample. The samples should be consistent from operator to operator.
  4. The fourth study is designed to show that the manufacturing of the device will be consistent from lot to lot.

Results of these studies will be foundational in our commercialization activities. Our clinical studies and laboratory teams have worked incredibly hard to do this important work to ensure medically accurate, quality results in varying collection and testing situations. Leading through science, we intend to set a new standard in the diagnostics industry. Stay tuned!