TECH OFFER

Non-invasive First-void Urine Device for Rapid Detection of Infectious Diseases and Cancer

KEY INFORMATION

TECHNOLOGY CATEGORY:
Healthcare - Diagnostics
Healthcare - Medical Devices
TECHNOLOGY READINESS LEVEL (TRL):
LOCATION:
Belgium
ID NUMBER:
TO174090

TECHNOLOGY OVERVIEW

The technology offers an effective and hygienic solution for capturing first void urine (typically defined as the first 20 mL of the urine flow) in a standardized volumetric way, thereby guaranteeing significantly increased analytic accuracy and patient comfort over classic urine sampling devices. The technology is highly user-friendly and allows for non-clinician dependent self-sampling in a home based setting. 

Due to the non-invasive character of urine sampling, it offers an alternative to clinician-dependent sampling such as pap smear, cervico-vaginal brushes, etc. 

The technology platform consists of multiple variants capturing a range of urine volumes for different application purposes. To allow for transportation and storage of the urine sample at room temperature, the technology is also available in combination with various urine stabilization chemistries that remove the need for cold-chain transportation and immediate cold storage of the collected samples.

TECHNOLOGY FEATURES & SPECIFICATIONS

The device is comprised of a housing component and a urine sampling tube. The design of the device allows a continuous urine flow and a fully hygienic sample taking and is decisively more user-friendly than a classic urine cup.

For each of the volume variants, the sampling tube is available in a neat fashion, but also prefilled with various urine stabilization chemistries. These stabilization buffers allow for transportation and storage of the urine sample at room temperature, and for an effective preservation of the urine samples, and thereby of the urine analytes of interest (nucleic acids, extracellular vesicles, proteins, cells, bacteria, etc).

POTENTIAL APPLICATIONS

  • Detection of infectious diseases (HPV, Sexually Transmitted Infections).
    • Especially for HPV detection (in the context of cervical cancer screening and monitoring), the technology has already proven its worth as a fully valid alternative to classical HPV detection methods, which tend to be (1) invasive in nature, and (2) clinician-dependent. Highly suitable as a home-based sampling device, the technology can help in lowering the current hurdles seen in cervical cancer screening and increasing the percentage of women participation in screening activities.
  • Detection and identification of oncology-related biomarkers (urological cancers like prostate cancer and bladder cancer, genital tract cancers, breast cancer, lung cancer, etc).
    • The number of analytical methods that use urine as a specimen type has strongly increased over recent years, indicating that urine can be in many applications a strong and valid alternative to strongly invasive tissue biopsies, but also as an alternative liquid biopsy compared to blood & plasma samples.

Market Trends & Opportunities

Several trends are seen in both the infectious diseases and oncology markets:

  • Patients want to take control over their own health
  • Availability of new very sensitive (high-throughput) molecular technologies is increasing rapidly
  • Increased use of lab automation to avoid pre-analytical errors, to reduce manual processing time and to shorten turn-around time
  • Increasing awareness and acceptance of personalized medicine and companion diagnostics
  • Covid-19 pandemic leading to an increased need for home-based solutions as people are going less to the clinics. Screening programs are impacted

The technology is offering the possibility for home-based urine collection, in a way that is compatible with various applications, and also directly compatible with automated high throughput lab systems. By reducing the overall turn-around time from sampling to result, use of personalized medicine can be favoured over the use of generic medicine.

Benefits

The technology

  • Offers a fully standardized volumetric collection of urine samples, in a range of 4 - 45 mL;
  • Is highly user-friendly and allows for continuous and hygienic urine sample taking;
  • Is available in different variants, both in volume and in urine stabilization chemistry, thereby offering a nearly tailor-made solution in multiple disease applications and downstream analysis lab settings. Compatibility with automated
  • Highly suited for home-based urine sample collection. The small volumes variant of the technology is available as a sampling kit that leverages local postal services to allow for a fully clinician-independent, home-based urine collection - a strong advantage to other sampling methods in the (post-)COVID era.

Furthermore, small volume variants of the technology are designed in such a way that the urine collection tube is compatible with various automated, high throughput analysis systems. This removes the need for unnecessary manual sample preparation and handling, and thereby (1) lowers the total cost of the sample analysis, (2) lowers the error rate, generally attributed to manual sample preparation steps, and (3) lowers the overall lead time from sample-to-result.

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