Novosanis brings Colli-Pee UAS FV-5040 with CE mark to the market offering a solution for oncology screening
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Novosanis now has a CE-mark for their Colli-Pee® device containing a prefilled tube with UAS® chemistry, which is designed to stabilize urinary analytes e.g. cfDNA, EV RNA. Together with our sister company DNA Genotek, we launched last year as RUO our novel stabilization chemistry, UAS, for the preservation of extracellular vesicle (EV) RNA, and cell-free DNA (cfDNA) in urine, collected with Colli-Pee. We are pleased to inform you that our product now has a CE-mark, offering solutions in the field of IVD and oncology research applications.
The award winning Colli-Pee now containing UAS preservative allows for instant preservation, standardized and volumetric collection of urine. The device architecture enables immediate mixing of urine with the preservative UAS, that prevents microbial growth and physiochemical changes.
Yellow is the new red | Urine for oncology screening
The use of non-invasive liquid biopsies for cancer research has gained interest over the past years. Several studies have shown the potential of urine as a sample type. Urine sampling offers several benefits:
- Easily accessible and available in larger quantities (approx. 40 mL)
- Applicable for home collection
- Cost efficient
- Ability to follow up disease or treatment by repeat sampling in time (compared to blood or biopsy)
- Not limited by the health status of a patient
- Does not entail any risk of transmission of blood-borne pathogens
UAS preservative is a solution with potential for oncology screening
UAS preservative has shown to prevent degradation of EV-RNA and cfDNA in first void urine collected with Colli-Pee® UAS® FV-5040 device.
UAS preservative offers the following characteristics:
- Prevents microbial growth for at least 7 days when stored at room temperature
- Preservative to sample ratio 2:5 for optimal preservation performance across a wide spectrum of urinary samples and applications
Next to technical assessment, UAS preservative has been evaluated on urine samples from the URODETECT project, which uses urine as a non-invasive liquid biopsy for prostate and breast cancer biomarker detection. First studies have already shown extraction compatibility for cfDNA filtration, centrifugation, and precipitation (Jordaens, 2022). Additional research projects are ongoing on characterization of EVs and patient cohort performance testing. Importantly, upon immediate mixing of urine with UAS, urine samples have shown stability of cfDNA and EV-RNA for at least 7 days at room temperature.
"Development of a urine preservative that can maintain the composition and integrity of a urine sample opens new avenues for cancer biomarker research" says Koen Beyers, CTO at Novosanis. “A big thank you to the teams at both Novosanis in Belgium and DNA Genotek in Canada. We’re all really excited about this CE launch.”