I recently had the opportunity to visit our new sister company, Novosanis⁺ in Antwerp, Belgium, to talk about urine as a sample type. Novosanis is dedicated to solving urine sampling challenges through its product Colli-Pee™ - an award-winning device designed to efficiently and hygienically capture first-void urine (the first 20ml of a urine sample). 

I spoke with CEO and co-founder, Vanessa Vankerckhoven. You may also listen to our full interview on our podcast: Molecules, Microbes and Multiomics.  

The key takeaways of our discussion

Why is first-void urine such an important sample type for researchers and clinicians?

First-void urine is very rich in DNA, RNA and proteins, ideally suited for molecular analysis and diagnostic purposes, such as the detection of sexually transmitted infections (STI’s), Human Papillomavirus (HPV) - which can cause cervical cancer - and biomarkers for early stage cancer detections (specifically urological - prostate).

“We’re already seeing commercial assays available in the United States using urine for early stage prostate cancer detection. Other possibilities include tuberculosis (TB) testing and vaginal microbiome discovery.”

What has been the impact of Colli-Pee on cancer biomarker discovery?

Current cancer detection is performed mainly through biopsies where tissue has to be taken from a patient. This can be both difficult to obtain and painful for the patient and in some cases not even feasible. When “tissue is an issue”, researchers and clinicians revert to liquid biopsies – mainly, blood. However, blood is still an invasive sample and, especially in the oncology space, more and more people are moving to urine as a sample type. “Yellow is the new Red.”

Colli-Pee has already been adopted by MDxHealth®, Exosome Diagnostics, and Diagnolita as the sample method for their assays in prostate cancer detection.  Additionally, recent literature is showing a huge variety of cancer biomarkers in urine - kidney^[1], bladder^[1], pancreas^[2], lung^[3] and even breast^[4].

How does Novosanis solve the challenges with collecting first-void urine?

When collecting a first-void urine sample, obtaining a volumetric and standardized sample is critical for optimizing downstream analysis.

“The biggest challenge with first-void urine is from the user’s perspective – it is very challenging to stop urinating after the first 20 ml and also difficult to aim and urinate properly into a small collection cup.” 

Colli-Pee is a novel collection device that allows the capture of first-void urine in a volumetric and standardized way. It is convenient and very easy to use – it solves the problem with aim as the collector includes a large funnel and there is no need to interrupt the urine flow (after the initial 20 ml is collected, the remainder passes freely through the device into the toilet).

“Cancer researchers, diagnostic companies, laboratories, and users all benefit from this technology.”

What do you think is the future of first-void urine as a sample type?

“The key to drive more research and diagnostics is non-invasive, easy-to-use sampling. Additionally, sample stabilization and preservation is key in detecting these analytes."

Novosanis is working on developing a home-based collection solution, including sample stabilization and easy sample shipping to improve patient access and research recruitment. 

Conclusion

The potential of first-void urine is vast and only somewhat known; but it is apparent to be a true multiomic sample type - crossing cancer genomics, infectious diseases, drug metabolites, and the microbiome.  We look forward to following the developments and applications of first-void urine sample.

For more information on first-void urine as a sample type and to request a free collection kit for evaluation, please email us at info@dnagenotek.com.

⁺Novosanis is a wholly owned subsidiary of OraSure Technologies Inc. ^‡ Colli-Pee is CE marked for in-vitro diagnostics in the EU and FDA listed as a Class I device in the USA.

References

[1] Lin SY, et al., Emerging Utility of Urinary Cell-free Nucleic Acid Biomarkers for Prostate, Bladder, and Renal Cancers. Eur Urol Focus (2017)
[2] R Roy et al., Urinary TIMP-1 and MMP-2 levels detect the presence of pancreatic malignancies. British Journal of Cancer (2014)
[3] Aleksandra Franovic, et al., Urine test for EGFR analysis in patients with non-small cell lung cancer J Thorac Dis (2017)
[4] Z. Liu et al., Association of urinary and plasma DNA in early breast cancer patients and its links to disease relapse. Clinical and Translational Oncology (2018)