Most people will at some stage have had to submit a urine sample for one thing or another. One of the most common tests in the doctor’s office, the process hasn’t changed much over the years. However, with new advances in diagnostics, urine samples can now be used to screen for a much wider range of maladies than was once possible, including a range of different cancer types.
That being said, not all pee is created equal: to diagnose certain diseases, a “dirty sample” containing lots of analytes is needed. What the doctors often need is a sample of first-void urine: the first 20 mL of the urine flow. Until recently, there was no easy and accurate way to catch this sample. Not until Novosanis tackled the issue and developed their simple yet brilliant product, the Colli-Pee®.
Designing a clever product
A few years ago, Vanessa Vankerckhoven was working as an innovation manager at the Vaccines and Infectious Disease Institute (VAXINFECTIO) at the University of Antwerp. She oversaw several Master projects on product development, including one that would eventually lead to the development of Colli-Pee® and the founding of Novosanis. Vankerckhoven told us:
“We basically bridged the knowledge and expertise at VAXINFECTIO with the product development group. There were two Master projects that arose from that partnership which eventually led to the main platforms at the heart of our company: the VAX-ID injection device and the Colli-Pee® urine collection device.”
The Master projects were purposefully given a multidisciplinary approach, taking into account not only product development and medical need, but also applied economics and social sciences. This allowed the team to determine the industrial design, clinical applicability and market potential of the devices early on, as well as the public receptiveness for a home-based sampling device like the Colli-Pee®. Once the groundwork was laid, Vankerckhoven then established ties with the design and engineering company Voxdale:
“We got involved with Voxdale pretty early on, which you don’t often see in academia. Usually, for device development at an academic level, you’ll have some research and initial prototyping, but you would not be investing into actual molding or finalized devices. This industry partnership allowed us to get one step ahead, which was very valuable for the company when starting to look for investors.”
In 2013, Novosanis was founded as a University of Antwerp spin-off, with Vankerckhoven as CEO. The company has since then done remarkably well for itself, with multiple partnerships and an acquisition earlier this year by OraSure Technologies. All these successes derive from the insightful, multidisciplinary way that the Colli-Pee® platform was developed from the start.
What makes the Colli-Pee® so special?
Ordinarily, when required to give a urine sample, a patient has to be in a doctor’s office or hospital and pee into a simple container. That container lacks several capabilities: it cannot specifically capture first-void urine, isn’t designed for a specific volume and cannot be used in a home setting (as the urine needs to be mixed with preservatives immediately).
Here’s where the Colli-Pee® comes in. When the Novosanis team were establishing the project that eventually resulted in the Colli-Pee®, they realized that there was a need for a sampling device that could specifically capture first-void urine in a hygienic and volumetric way. The device they developed is simple, yet brilliant: by peeing into a funnel, which is attached to a container with a floatation system, the first 20 mL of urine can be captured while the rest runs into the toilet bowl without any mixing or mess. What’s more, the container can be pre-filled with preservatives, meaning the device can be mailed to the patient using a regular postal service and mailed back without compromising the sample.
Image: the Colli-Pee® urine sampling device (courtesy of Novosanis).
The device was developed both to overcome the technical challenge of capturing a specific volume of first-void urine, as well as patient participation issues. In the initial Master project, their social sciences research uncovered a reluctance towards clinical tests, even for non-invasive ones like urine sampling, that can be overcome by this sort of a home-based, self-sampling system. It lowers the threshold for sampling, particularly for low-income, high-risk and resource-poor communities.
Useful urine
The Colli-Pee® was initially developed to provide a minimally invasive way of following-up on HPV vaccinations in young girls. It then went on to become a useful tool for many different forms of Sexually Transmitted Infections (STIs), including Chlamydia and Gonorrhea.
With the increasing power of diagnostic tools, urine can now also be used to diagnose a range of cancers. To this purpose, the Colli-Pee® can be used to help diagnose bladder cancer, prostate cancer, and even breast and lung cancer. Vankerckhoven commented:
“Non-invasive, home-based sampling is becoming key in oncology due to developments in molecular diagnostics. We spotted this trend pretty early and were therefore well-poised to serve the market regarding biomarker testing.”
Providing solutions to diagnostic companies, which are Novosanis’ primary clients, has led to the development of several new Colli-Pee® size variants. Vankerckhoven explained:
“We now have a larger 45 mL collection tube which is relevant for some cancer types (such as bladder, breast or lung cancer) where you need a larger sample volume because the number of analytes in the urine is low.
Smaller sample sizes, on the other hand, are key for lab purposes, because they can be used to automate the diagnostic process. To serve the lab sector we’ve also developed a 10 mL variant that can be put directly onto the machines. So, no more pipetting, no more manual errors.
Since the start of this year, we’ve also started moving into the research field, providing collection kits to academia for their early-stage developments.”
The Colli-Pee® is being used across the world on almost every continent. The success of this simple sampling solution really comes down to the foresight granted by approaching the initial project from multiple angles, including the incorporation of design at an early stage of the development process. From Master project to international success, budding start-ups would certainly do well to learn from Novosanis’ approach.
